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This study will evaluate the effect of 8 doses of intranasal oxytocin or placebo on two proposed measures of target engagement in brain. The targets are (1) the suppression of a particular wave form (mu) on the electroencephalogram (EEG) while subjects observe a socially relevant form of motion and (2) pupil dilation will subjects identify faces showing different emotions.
Subjects with schizophrenia spectrum disorders will be randomly assigned to one of 8 doses of oxytocin. After screening and informed consent subjects will receive either their assigned dose or a placebo. Thirty minutes following the drug administration patients will be evaluated on the EEG and pupillometry tasks followed by two tests that evaluate social salience. One week later subjects will have a second challenge in the alternative (drug or placebo) condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin 6-84 IU | Experimental | Subjects will be randomly assigned to one of eight doses of intranasal oxytocin. |
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| Placebo | Placebo Comparator | Subjects will be administered intranasal placebo using the same spray volume as experimental condition |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Oxytocin | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Mu Suppression on EEG | This primary outcome measure is mu suppression recorded during a biological motion task. In this task, participants view point-light walker (PLW) animations of a human; the PLWs were either male or female, happy or sad, or walking towards or away from the viewer. In addition to the humans, there was a control condition which consisted of a circle moving either left or right. In separate blocks, participants had to identify either the gender, the emotion, or intention (i.e., direction) of the walker, or the direction of the circle, while their EEG was recorded. The primary measure was mu activity (8-12 Hz) recorded over 3 central electrodes. Mu suppression was calculated as the log10 transformed ratio of mu power to one of the three human conditions compared to the circle: log10(human/circle). A negative value indicates suppression of mu activity to human walkers vs. circles. We are presenting the mean (SD) of this suppression ratio collapsed over the 3 human conditions. | Baseline, 1 Week |
| Pupil Dilation While Observing Faces | This primary outcome measure is pupil size recorded during a facial affect identification task. In this task, participants view faces portraying happy, afraid, or neutral faces; scrambled images of the faces were also shown. There were 64 trials: 16 trials per each image type. The primary measure was the difference in pupil size averaged over the happy and fearful faces from the scrambled face condition. A positive value indicates greater pupil dilation relative to the scrambled face; a negative value indicates greater pupil constriction relative to the scrambled face. Baseline was defined as the median pupil width 1 second prior to stimulus onset. Pupil sizes during each trial were baseline-corrected by dividing them by baseline median width. Resulting pupil size timecourses were averaged within-subject for each type of stimulus (happy, afraid, neutral, scrambled). The primary dependent variable was computed by taking the average of the change in pupil size between 1 and 3 s. | Baseline, 1 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 8IU Oxytocin | Subjects received either 8IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| FG001 | 12IU Oxytocin | Subjects received either 12IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| FG002 | 24IU Oxytocin | Subjects received either 24IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| FG003 | 36IU Oxytocin | Subjects received either 36IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| FG004 | 48IU Oxytocin | Subjects received either 48IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| FG005 | 60IU Oxytocin | Subjects received either 60IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| FG006 | 72IU Oxytocin | Subjects received either 72IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| FG007 | 84IU Oxytocin | Subjects received either 84IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who completed both study visits
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| ID | Title | Description |
|---|---|---|
| BG000 | 8IU Oxytocin | Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| BG001 | 12IU Oxytocin |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mu Suppression on EEG | This primary outcome measure is mu suppression recorded during a biological motion task. In this task, participants view point-light walker (PLW) animations of a human; the PLWs were either male or female, happy or sad, or walking towards or away from the viewer. In addition to the humans, there was a control condition which consisted of a circle moving either left or right. In separate blocks, participants had to identify either the gender, the emotion, or intention (i.e., direction) of the walker, or the direction of the circle, while their EEG was recorded. The primary measure was mu activity (8-12 Hz) recorded over 3 central electrodes. Mu suppression was calculated as the log10 transformed ratio of mu power to one of the three human conditions compared to the circle: log10(human/circle). A negative value indicates suppression of mu activity to human walkers vs. circles. We are presenting the mean (SD) of this suppression ratio collapsed over the 3 human conditions. | Posted | Mean | Standard Deviation | log10 transformed ratio (Hz) | Baseline, 1 Week |
|
One week. Participants were only enrolled for a one week period in which placebo or drug were administered (in random order) either at baseline or 1-week follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 8IU Oxytocin | Subjects received either 8IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen R. Marder | University of California, Los Angeles | 3104783711 | 83647 | SMarder@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 9, 2016 | Oct 4, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Equipment failure |
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| Withdrawal by Subject |
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Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later.
| BG002 | 24IU Oxytocin | Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| BG003 | 36IU Oxytocin | Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| BG004 | 48IU Oxytocin | Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| BG005 | 60IU Oxytocin | Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| BG006 | 72IU Oxytocin | Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| BG007 | 84IU Oxytocin | Subjects received either the assigned Oxytocin dose or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. |
| BG008 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Each row corresponds to a dose of oxytocin. The sum of the participants in each row totals 47, which is the overall analyzed population. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 8IU Oxytocin |
8 international units (IU) of Oxytocin |
| OG001 | 12IU Oxytocin | 12 international units (IU) of Oxytocin |
| OG002 | 24IU Oxytocin | 24 international units (IU) of Oxytocin |
| OG003 | 36IU Oxytocin | 36 international units (IU) of Oxytocin |
| OG004 | 48IU Oxytocin | 48 international units (IU) of Oxytocin |
| OG005 | 60IU Oxytocin | 60 international units (IU) of Oxytocin |
| OG006 | 72IU Oxytocin | 72 international units (IU) of Oxytocin |
| OG007 | 84IU Oxytocin | 84 international units (IU) of Oxytocin |
| OG008 | Placebo | Placebo condition. This represents the placebo data summarized across all participants regardless as to which dose of oxytocin (OT) they received. |
|
|
| Primary | Pupil Dilation While Observing Faces | This primary outcome measure is pupil size recorded during a facial affect identification task. In this task, participants view faces portraying happy, afraid, or neutral faces; scrambled images of the faces were also shown. There were 64 trials: 16 trials per each image type. The primary measure was the difference in pupil size averaged over the happy and fearful faces from the scrambled face condition. A positive value indicates greater pupil dilation relative to the scrambled face; a negative value indicates greater pupil constriction relative to the scrambled face. Baseline was defined as the median pupil width 1 second prior to stimulus onset. Pupil sizes during each trial were baseline-corrected by dividing them by baseline median width. Resulting pupil size timecourses were averaged within-subject for each type of stimulus (happy, afraid, neutral, scrambled). The primary dependent variable was computed by taking the average of the change in pupil size between 1 and 3 s. | Posted | Mean | Standard Deviation | arbitrary units | Baseline, 1 Week |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 12IU Oxytocin | Subjects received either 12IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 24IU Oxytocin | Subjects received either 24IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | 36IU Oxytocin | Subjects received either 36IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | 48IU Oxytocin | Subjects received either 48IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | 60IU Oxytocin | Subjects received either 60IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG006 | 72IU Oxytocin | Subjects received either 72IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG007 | 84IU Oxytocin | Subjects received either 84IU Oxytocin or placebo 30 minutes prior to study assessments, and a second challenge in the alternative (drug or placebo) condition one week later. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG008 | Placebo | Placebo condition. This represents the placebo data summarized across all participants regardless as to which dose of oxytocin (OT) they received. | 0 | 47 | 0 | 47 | 0 | 47 |
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