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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH118634-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to better understand mental illness and will test the hypotheses that, while viewing affective stimuli, patient groups will show increased blood oxygenation level dependent (BOLD) signal by fMRI after lorazepam.
This study will enroll participants between the ages of 16 and 60, who have a psychotic illness (such as psychosis which includes conditions like schizophrenia, schizoaffective disorder, and mood disorders like bipolar disorder). The study will also enroll eligible participants between the ages of 18 and 60 without any psychiatric illness to compare their brains.
The study will require participants to have 3-4 sessions over a few weeks. The initial assessments (may be over two visits) will include a diagnostic interview and several questionnaires (qols) to assess eligibility. Subsequently, there will be two separate functional magnetic resonance imaging (fMRI) sessions in which lorazepam or placebo will be given prior to the fMRI. During the fMRI, the participants will also be asked to answer questions. Additionally, the participants will have their blood drawn, vital signs will be taken, they will be asked to complete more qols, and women of childbearing potential will have a urine pregnancy test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Placebo Comparator |
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| Early Psychosis patients | Experimental |
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| Schizophrenia or Schizoaffective disorder patients | Experimental |
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| Bipolar disorder patients | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo and fMRI | Other | There will be two fMRIs done after the initial assessment and approximately 28 days apart. Females may need to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo will be given approximately 80-90 minutes prior to entering the fMRI scanner. Participants will complete assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants will be asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Oxygen Level Dependent (BOLD) Change in Medial Frontal Cortex While Viewing Affective Pictures | Change in brain activity in the medial frontal cortex after being given lorazepam, a medication that changes the activity of GABAergic neurons. Results reflect the difference/change in brain signal between the lorazepam scan and the placebo scan. BOLD change in the dorsomedial prefrontal cortex (dmPFC) was summarized using MATLAB (MatrixLaboratory)'s SPM (Statistical Parametric Mapping) package for eigenvariate extraction, which extracts the first principal component of the voxel time series within an region of interest (ROI). The resulting values are in arbitrary units (AU) reflecting variance-normalized signal after temporal filtering and serial correlation correction, which removes absolute signal scaling. While AU values are not directly interpretable as percent signal change, they preserve relative differences in BOLD change across conditions and are appropriate for statistical comparison. | Approximately 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Levels of Negative Affect | Levels of negative affect were calculated from a PCA of self-report scales: Psychological Stress Index (PSI9; 9-item, Min=0, Max=36, higher=more stress), negative emotions from Modified Differential Emotions Scale (mDES; 8-item subscale, Min=0, Max=32, higher=more negative emotion), Beck Depression Inventory (BDI; 21-item, Min=0, Max=63, higher=more depression). Each measure was completed twice (pre-placebo and pre-drug). The PCA used the prcomp function in R (version 4.5.3), with variables from each scale centered and scaled to unit variance. The 1st principal component of PCA was used as index of general negative affect. This component explained 79% of the total variance across the 6 input measures. Individual component scores were extracted for each participant (Range Min=-3.352, Max=7.067, arbitrary units, higher values=more negative affect/worse outcome). |
Early psychosis (EP) patients:
Inclusion Criteria:
Exclusion Criteria:
Schizophrenia/schizoaffective (SCZ) and bipolar affective disorder (BAD) patients:
Inclusion Criteria:
Exclusion Criteria:
Healthy control subjects:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Taylor, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
The PI will share information about this/these trial(s) via timely registration, updates, and results reporting in ClinicalTrials.gov in accordance with NIH policy.
The PI will also upload data gathered in this proposal to an National Institute of Mental Health (NIMH)-designated central data, NIMH Data Archive (NDA), as prescribed by NOT-MH-15-012, working with NIMH program to determine the timing and extent of data sharing. This includes formulation of an enrollment strategy that will obtain the information necessary to generate a Global Unique Identifier (GUID) for each participant.
The consent form will include language indicating the intention to upload de-identified data into the central archive, and permission will be obtained from University of Michigan Institutional Review Board to do so. The budget includes a data manager to cover the costs of managing the data, building the data dictionary and harmonizing it with data structures.
De-identified data will be entered into the NDA within 1 year of the conclusion of the study.
No additional access restrictions will be placed on the de-identified data beyond those that are standard for the NDA.
Of the 240 participants consented, 97 were determined to be ineligible for the trial, leaving 143 total enrolled (17 Early Psychosis patients, 35 Schizophrenia or Schizoaffective disorder patients, 30 Bipolar disorder patients, 61 Healthy controls). Of those 143 enrolled, 24 participants were never randomized to a treatment order. 8 withdrew; 9 were lost to follow-up, and 7 were removed due to physician decision (ex, a change in participant eligibility).
Participants were targeted for recruitment from clinical sites (ex, Program for Risk Evaluation and Prevention (PREP) clinic) using medical record review and/or clinician referral. They were also recruited through research registries (ex, UMHealthResearch.org, departmental psychiatric research registry), via community advertisements (ex, flyers), internet sources such as social media (ex, Facebook/Instagram/Google AdWords paid campaigns), and email blasts.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Psychosis Patients - Lorazepam 0.01 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First fMRI Visit |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2024 |
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The two MRI sessions will be scheduled approximately 28 days apart. If you are a woman, we may need to schedule the scanning session to coincide with a certain phase of your menstrual cycle.
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Study coordinator and participant are blinded to medication administration.
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| Lorazepam and fMRI | Drug | There will be two fMRIs done after the initial assessment and approximately 28 days apart. Females may need to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam (assigned to one of two dose levels between subjects: 0.01 mg/kg or 0.02 mg/kg) will be given approximately 80-90 minutes prior to entering the fMRI scanner. Participants will complete assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants will be asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
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| Approximately 28 days |
| FG001 | Early Psychosis Patients - Lorazepam 0.02 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG002 | Early Psychosis Patients - Placebo First, Lorazepam 0.01 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG003 | Early Psychosis Patients - Placebo First, Lorazepam 0.02 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG004 | Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.01 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG005 | Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG006 | Schizophrenia or Schizoaffective Disorder Patients - Placebo First, Lorazepam 0.01 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG007 | Schizophrenia or Schizoaffective Disorder Patients - Placebo First, Lorazepam 0.02 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG008 | Bipolar Disorder Patients - Lorazepam 0.01 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG009 | Bipolar Disorder Patients - Lorazepam 0.02 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG010 | Bipolar Disorder Patients - Placebo First, Lorazepam 0.01 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG011 | Bipolar Disorder Patients - Placebo First, Lorazepam 0.02 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG012 | Healthy Controls - Lorazepam 0.01 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG013 | Healthy Controls - Lorazepam 0.02 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG014 | Healthy Controls - Placebo First, Lorazepam 0.01 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| FG015 | Healthy Controls - Placebo First, Lorazepam 0.02 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
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| Time Between fMRI Visits |
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| Second fMRI Visit |
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Psychosis Patients - Lorazepam 0.01 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG001 | Early Psychosis Patients - Lorazepam 0.02 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG002 | Early Psychosis Patients - Placebo First, Lorazepam 0.01 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG003 | Early Psychosis Patients - Placebo First, Lorazepam 0.02 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG004 | Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.01 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG005 | Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG006 | Schizophrenia or Schizoaffective Disorder Patients - Placebo First, Lorazepam 0.01 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG007 | Schizophrenia or Schizoaffective Disorder Patients - Placebo First, Lorazepam 0.02 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG008 | Bipolar Disorder Patients - Lorazepam 0.01 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG009 | Bipolar Disorder Patients - Lorazepam 0.02 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG010 | Bipolar Disorder Patients - Placebo First, Lorazepam 0.01 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG011 | Bipolar Disorder Patients - Placebo First, Lorazepam 0.02 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG012 | Healthy Controls - Lorazepam 0.01 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG013 | Healthy Controls - Lorazepam 0.02 mg/kg First, Placebo Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG014 | Healthy Controls - Placebo First, Lorazepam 0.01 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG015 | Healthy Controls - Placebo First, Lorazepam 0.02 mg/kg Second | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| BG016 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Oxygen Level Dependent (BOLD) Change in Medial Frontal Cortex While Viewing Affective Pictures | Change in brain activity in the medial frontal cortex after being given lorazepam, a medication that changes the activity of GABAergic neurons. Results reflect the difference/change in brain signal between the lorazepam scan and the placebo scan. BOLD change in the dorsomedial prefrontal cortex (dmPFC) was summarized using MATLAB (MatrixLaboratory)'s SPM (Statistical Parametric Mapping) package for eigenvariate extraction, which extracts the first principal component of the voxel time series within an region of interest (ROI). The resulting values are in arbitrary units (AU) reflecting variance-normalized signal after temporal filtering and serial correlation correction, which removes absolute signal scaling. While AU values are not directly interpretable as percent signal change, they preserve relative differences in BOLD change across conditions and are appropriate for statistical comparison. | Both fMRI scans are necessary to calculate the difference/change in brain signal between the lorazepam scan and the placebo scan, so participants were not analyzed if they did not provide usable data at both fMRIs. Reasons for unusable data included withdrawal (for example, due to no longer being eligible), loss to follow-up, unresponsiveness during the image viewing task, excessive movement, and fMRI image distortion. | Posted | Mean | Standard Deviation | AU | Approximately 28 days |
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| Other Pre-specified | Levels of Negative Affect | Levels of negative affect were calculated from a PCA of self-report scales: Psychological Stress Index (PSI9; 9-item, Min=0, Max=36, higher=more stress), negative emotions from Modified Differential Emotions Scale (mDES; 8-item subscale, Min=0, Max=32, higher=more negative emotion), Beck Depression Inventory (BDI; 21-item, Min=0, Max=63, higher=more depression). Each measure was completed twice (pre-placebo and pre-drug). The PCA used the prcomp function in R (version 4.5.3), with variables from each scale centered and scaled to unit variance. The 1st principal component of PCA was used as index of general negative affect. This component explained 79% of the total variance across the 6 input measures. Individual component scores were extracted for each participant (Range Min=-3.352, Max=7.067, arbitrary units, higher values=more negative affect/worse outcome). | Both fMRI scans are necessary to calculate the difference/change in brain signal between the lorazepam scan and the placebo scan, so participants were not analyzed if they did not provide usable data at both fMRIs. Reasons for unusable data included withdrawal (for example, due to no longer being eligible), loss to follow-up, unresponsiveness during the image viewing task, excessive movement, and fMRI image distortion. | Posted | Mean | Standard Deviation | Principal Component Analysis Score | Approximately 28 days |
|
From treatment administration (randomized Lorazepam or Placebo) until their trial completion or withdrawal, approximately 40 weeks
Although all 119 were administered a treatment, not all were administered both Lorazepam and Placebo, due to incompletion (ex, loss to follow-up). 113 were administered Lorazepam; 114 were administered Placebo. Serious Adverse Events were identified systematically via medical record alert, but any participant self-reported events were also logged. Some participants' adverse event time frames were extended due to failed attempts to reignite contact prior to their eventual withdrawal.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lorazepam 0.01 mg/kg Window | Approximately 80-90 minutes prior to entering the fMRI scanner, a dose of Lorazepam 0.01 mg/kg was given. If administered at the first fMRI, there were approximately 28 days before the second fMRI. If administered at the second fMRI, the participant's participation ended after the scan. This delivery order was randomly assigned, and the study coordinator and participant were blinded to its administration. | 0 | 57 | 1 | 57 | 1 | 57 |
| EG001 | Lorazepam 0.02 mg/kg Window | Approximately 80-90 minutes prior to entering the fMRI scanner, a dose of Lorazepam 0.02 mg/kg was given. If administered at the first fMRI, there were approximately 28 days before the second fMRI. If administered at the second fMRI, the participant's participation ended after the scan. This delivery order was randomly assigned, and the study coordinator and participant were blinded to its administration. | 0 | 56 | 1 | 56 | 6 | 56 |
| EG002 | Placebo Window | Approximately 80-90 minutes prior to entering the fMRI scanner, a dose of Placebo was given. If administered at the first fMRI, there were approximately 28 days before the second fMRI. If administered at the second fMRI, the participant's participation ended after the scan. This delivery order was randomly assigned, and the study coordinator and participant were blinded to its administration. | 0 | 114 | 0 | 114 | 5 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dizziness | General disorders | Non-systematic Assessment |
| ||
| Incidental Finding | Nervous system disorders | Systematic Assessment |
| ||
| Symptom worsening | Psychiatric disorders | Systematic Assessment |
| ||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan Taylor | University of Michigan | (734) 936-4955 | sftaylor@med.umich.edu |
| Nov 18, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2024 | Mar 10, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG004 | Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg | Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG005 | Schizophrenia or Schizoaffective Disorder Patients - Placebo | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG006 | Bipolar Disorder Patients - Lorazepam 0.01 mg/kg | Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG007 | Bipolar Disorder Patients - Lorazepam 0.02 mg/kg | Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG008 | Bipolar Disorder Patients - Placebo | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG009 | Healthy Controls - Lorazepam 0.01 mg/kg | Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG010 | Healthy Controls - Lorazepam 0.02 mg/kg | Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG011 | Healthy Controls - Placebo | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG001 | Early Psychosis Patients - Lorazepam 0.02 mg/kg | Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG002 | Early Psychosis Patients - Placebo | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG003 | Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.01 mg/kg | Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG004 | Schizophrenia or Schizoaffective Disorder Patients - Lorazepam 0.02 mg/kg | Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG005 | Schizophrenia or Schizoaffective Disorder Patients - Placebo | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG006 | Bipolar Disorder Patients - Lorazepam 0.01 mg/kg | Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG007 | Bipolar Disorder Patients - Lorazepam 0.02 mg/kg | Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG008 | Bipolar Disorder Patients - Placebo | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG009 | Healthy Controls - Lorazepam 0.01 mg/kg | Lorazepam and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.01 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG010 | Healthy Controls - Lorazepam 0.02 mg/kg | Lorazepam and fMRI: There were wo fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Lorazepam 0.02 mg/kg was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
| OG011 | Healthy Controls - Placebo | Placebo and fMRI: There were two fMRIs done after the initial assessment and approximately 28 days apart. Females may have needed to have this scheduled to coincide with a certain phase of their menstrual cycle. A dose of Placebo was given approximately 80-90 minutes prior to entering the fMRI scanner. Participants completed assessments (vitals, questionnaires) and an optional blood draw prior to having each fMRI. Participants were asked to rate pleasant/unpleasant pictures during their initial assessment visit and to view them during the fMRI. |
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