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| ID | Type | Description | Link |
|---|---|---|---|
| 19-27265 | Other Identifier | University of California, San Francisco | |
| 1I01CX001761-01A2 | U.S. NIH Grant/Contract | View source |
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Inadequate Subject Recruitment
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| VA Greater Los Angeles Healthcare System | FED |
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Schizophrenia has a devastating and disproportionate effect on veterans compared to the general US population. Some of the most disabling symptoms, such as low motivation, difficulty expressing emotions, and decreased ability to infer the mental states of others, cause poor social functioning. This means that veterans with schizophrenia have trouble navigating interpersonal interactions and building meaningful relationships in the community. Unfortunately, current antipsychotic medications typically only improve positive symptoms but fail to improve social functioning deficits, which are strong predictors of poor quality of life and functional outcomes. Oxytocin, a peptide found in the brain, plays an important role in social behavior and is known to moderate affiliation, stress, and learning across taxa. In this study, the investigators will test whether oxytocin could be an effective treatment for social functioning deficits in schizophrenia. The investigators will examine changes in brain activation to understand how oxytocin affects behavior and to predict which individuals may benefit from oxytocin treatment.
The study uses a combined within- and between-subject placebo-controlled study design.
Within subjects phase: After screening, participants will be randomized into two study arms for the fMRI phase of the study. In each study arm, participants will complete a placebo-controlled, within-subject, pharmaco-fMRI paradigm with one of two possible dosages of oxytocin (20 or 40IU) and placebo. Following the fMRI phase of the study, participants will be randomized for the next phase of the study
Between subjects phase: Participants will receive the same dosage of oxytocin the participant received in the fMRI phase, or placebo, twice daily for 3 weeks. Before and after the three weeks of drug administration, participants will be assessed for social functioning, social ability, negative symptoms, and theory of mind. More participants will be randomized to receive chronically administered oxytocin than placebo to maximize the study's power to test the investigators' hypothesis that acute oxytocin-induced increases in right temporo-parietal junction activity will be positively correlated with improvements in social functioning (primary outcome), social ability, negative symptoms, and theory of mind over three weeks of oxytocin administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Oxytocin | Experimental | Dosages of oxytocin: 20IU or 40IU. |
|
| Placebo | Placebo Comparator | Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Intranasal administration of oxytocin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Social Functioning Score | The Social Functioning Scale is a 79-item semi-structured interview based assessment that includes [a global summary score (primary outcome)] The subscale scores of social engagement, interpersonal communication, and prosocial were expected the change in 3 weeks, while other subscales were not expected to change (e.g. employment) and thus were not collected during the chronic period. Scale ranges from 0 to lower functioning to 90 higher functioning. | Baseline visit: Full assessment is collected prior to any treatments fMRI phase: assessment not collected Chronic phase: partial assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration |
| Measure | Description | Time Frame |
|---|---|---|
| CAINS Score (Clinical Assessment Interview for Negative Symptoms) | Negative symptoms will be assessed with the CAINS (clinical assessment interview for negative symptoms) comprised of several subscales that will be summed for a global score. Each item is assessed from 0-no impairment to 4-severe deficit. The total score from 0 to 52 where higher scores represent more significant impairment. | Baseline visit: assessment is collected prior to any treatments fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration |
| Measure | Description | Time Frame |
|---|---|---|
| QLS Scale (Quality of Life) | Quality of Life will be assessed with the Quality of Life Scale (QLS), a 9-item assessment that measures domains such as interpersonal relations, occupation role functioning, and intrapsychic foundations. Each item is rated from 0 to 6 with the lower values indicating greater severity of symptoms. As such, the total score ranges from 0-54 (higher scores indicate good quality of life). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josh Woolley, BS | San Francisco VA Medical Center, San Francisco, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | 94121-1563 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | fMRI phase: 2 fMRI scans - 20IU single administration oxytocin and placebo Chronic Phase: 20IU oxytocin for 3 weeks |
| FG001 | Arm 2 | fMRI phase (within subject): 2 fMRI scans - 20IU single administration oxytocin + placebo Chronic Phase: placebo for 3 weeks |
| FG002 | Arm 3 | fMRI phase: 2 fMRI scans - 40IU single administration oxytocin + placebo Chronic Phase: 40IU oxytocin for 3 weeks |
| FG003 | Arm 4 | fMRI phase: 2 fMRI scans - 40IU single administration oxytocin + placebo Chronic Phase: placebo for 3 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only individuals who completed all outcome assessment timepoints were included in the results calculation
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | fMRI phase: 20IU single administration oxytocin Chronic phase: 20IU oxytocin for 3 weeks |
| BG001 | Arm 2 | fMRI phase: 20IU single administration oxytocin Chronic phase: placebo for 3 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Social Functioning Score | The Social Functioning Scale is a 79-item semi-structured interview based assessment that includes [a global summary score (primary outcome)] The subscale scores of social engagement, interpersonal communication, and prosocial were expected the change in 3 weeks, while other subscales were not expected to change (e.g. employment) and thus were not collected during the chronic period. Scale ranges from 0 to lower functioning to 90 higher functioning. | Data for an individual was only included if both assessment timepoints were completed in full (i.e. no missing values) | Posted | Mean | Full Range | score on a scale | Baseline visit: Full assessment is collected prior to any treatments fMRI phase: assessment not collected Chronic phase: partial assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration |
|
approx. 6 weeks: from first visit to final visit
Note: Participants completed 2 phases of the same arm. Including 1 fMRI phase and 1 Chronic Phase. Thus participants are reported twice in this section
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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 | Arm 1 fMRI Phase | fMRI phase: 20IU single administration oxytocin | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic Mass | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | pt reported a growth near the pelvis and planned to follow up with their regular care team. Growth had been know to the pt prior to receiving study drug, however had not been disclosed during participation |
Study did not reach target enrollment numbers needed to achieve target power and statistically reliable results
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Josh Woolley | San Francisco VA Medical Center | 415-221-4810 | 24117 | joshua.woolley@va.gov |
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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 | Jan 25, 2023 | Mar 26, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2022 | Jul 11, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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The study uses a combined within- and between-subject placebo-controlled study design. After screening, participants will be randomized into two study arms for the fMRI phase of the study. In each study arm, participants will complete a placebo-controlled, within-subject, pharmaco fMRI paradigm with one of two possible dosages of oxytocin (20 or 40IU) and placebo. 75 participants will be randomized to receive 20IU oxytocin and placebo and 75 will be randomized to receive 40IU oxytocin and placebo, with the order of administration randomized and separated by two weeks. Following the fMRI phase of the study, participants will be randomized to receive the same dosage of oxytocin the participant received in the fMRI phase, or placebo, twice daily for 3 weeks.
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Double Blind
| Placebo | Drug | Placebo |
|
| Baseline visit: assessment not collected fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration |
| Hinting Task | Theory of Mind (ToM) will be assessed using The Hinting Task, a well-validated tool where participants make social inferences after hearing 10 fictional conversations. Each conversation ends with one character's utterance and the participant is asked to determine its meaning. Each item is scored from 0 to 2. The summed values of the scale from 0 to 20, where higher values represent better theory of mind / higher functioning | Baseline visit: assessment not collected fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA |
| West Los Angeles |
| California |
| 90073 |
| United States |
| BG002 | Arm 3 | fMRI phase: 40IU single administration oxytocin Chronic phase: 40IU oxytocin for 3 weeks |
| BG003 | Arm 4 | fMRI phase: 40IU single administration oxytocin Chronic phase: placebo for 3 weeks |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
fMRI phase: 20IU single administration oxytocin Chronic Phase: 20IU oxytocin for 3 weeks
| OG001 | Arm 2 | fMRI phase (within subject): 20IU single administration oxytocin Chronic Phase: placebo for 3 weeks |
| OG002 | Arm 3 | fMRI phase: 40IU single administration oxytocin Chronic Phase: 40IU oxytocin for 3 weeks |
| OG003 | Arm 4 | fMRI phase: 40IU single administration oxytocin Chronic Phase: placebo for 3 weeks |
|
|
| Secondary | CAINS Score (Clinical Assessment Interview for Negative Symptoms) | Negative symptoms will be assessed with the CAINS (clinical assessment interview for negative symptoms) comprised of several subscales that will be summed for a global score. Each item is assessed from 0-no impairment to 4-severe deficit. The total score from 0 to 52 where higher scores represent more significant impairment. | Data for an individual was only included if the assessment was completed in full | Posted | Mean | Full Range | score on a scale | Baseline visit: assessment is collected prior to any treatments fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration |
|
|
|
| Other Pre-specified | QLS Scale (Quality of Life) | Quality of Life will be assessed with the Quality of Life Scale (QLS), a 9-item assessment that measures domains such as interpersonal relations, occupation role functioning, and intrapsychic foundations. Each item is rated from 0 to 6 with the lower values indicating greater severity of symptoms. As such, the total score ranges from 0-54 (higher scores indicate good quality of life). | Data for an individual was only included if the assessment was completed in full | Posted | Mean | Full Range | score on a scale | Baseline visit: assessment not collected fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration |
|
|
|
| Other Pre-specified | Hinting Task | Theory of Mind (ToM) will be assessed using The Hinting Task, a well-validated tool where participants make social inferences after hearing 10 fictional conversations. Each conversation ends with one character's utterance and the participant is asked to determine its meaning. Each item is scored from 0 to 2. The summed values of the scale from 0 to 20, where higher values represent better theory of mind / higher functioning | Data for an individual was only included if the assessment was completed in full | Posted | Mean | Full Range | score on a scale | Baseline visit: assessment not collected fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration |
|
|
|
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Arm 2 fMRI Phase | fMRI phase: 20IU single administration oxytocin | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Arm 3 fMRI Phase | fMRI phase: 40IU single administration oxytocin | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Arm 4 fMRI Phase | fMRI phase: 40IU single administration oxytocin | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | Arm 1 Chronic Phase | Chronic Phase: 20IU oxytocin for 3 weeks | 0 | 2 | 0 | 2 | 0 | 2 |
| EG005 | Arm 2 Chronic Phase | Chronic Phase: placebo for 3 weeks | 0 | 2 | 0 | 2 | 0 | 2 |
| EG006 | Arm 3 Chronic Phase | Chronic Phase: 40IU oxytocin for 3 weeks | 0 | 6 | 0 | 6 | 1 | 6 |
| EG007 | Arm 4 Chronic Phase | Chronic Phase: placebo for 3 weeks | 0 | 3 | 0 | 3 | 0 | 3 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| A1 |
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| A2 |
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| A2 |
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| A2 |
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