| ID | Type | Description | Link |
|---|---|---|---|
| R34MH091285 | U.S. NIH Grant/Contract | View source |
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Break in funding
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms despite being on adequate treatment with antipsychotic medication.
This is two-site clinical study taking place at UCSD and UCI. Approximately 71 patients at each site will be randomly assigned to either intranasal oxytocin or vehicle placebo at this site.
The total duration for each individual subject will be 6 weeks on study medication (placebo or oxytocin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin: Low Dose | Experimental | 42 IU BID for the six weeks |
|
| Oxytocin: High Dose | Experimental | 84 IU BID for six weeks |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 42 IU BID for six weeks |
| |
| Oxytocin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint | The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment of Functioning (GAF) | The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning). | 6 weeks |
| Clinical Global Impression-Severity of Illness (CGI-S) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Permitted:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| David Feifel, MD, Ph.D | UCSD | Principal Investigator |
| Steven Potkin, MD | UCI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92037 | United States | ||
| University of California, San Diego |
The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| 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 | Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint | The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances. | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
Not provided
The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
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 | All Participants | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. |
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The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Feifel | UCSD | (858) 412-4130 | dfeifel@kadimanp.com |
Not provided
| 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 | Jul 22, 2013 | Aug 20, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Not provided
| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
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| Drug |
84 IU BID for six weeks |
|
| Placebo | Drug | Vehicle placebo |
|
The CGI-S is used to evaluate changes in overall severity of illness. Scores range from 1 (not at all) to 7 (among the most extremely ill). |
| 6 weeks |
| Clinical Global Impression-Global Improvement (CGI-I) | The CGI-I is a global assessment to evaluate the subject's improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse). | 6 weeks |
| Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®) | The CMINDS ® consists of "construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™). | 6 weeks |
| Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEITâ„¢ ME) | The MSCEITâ„¢ ME is a multiple choice test that asses how individuals manage their emotions. | 6 weeks |
| Calgary Depression Scale for Schizophrenia (CDSS) | The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient. | 6 weeks |
| Hamilton-Anxiety Scale (HAM-A) | The HAM-A is a clinician administered scale for the evaluation of anxiety symptoms. It consists of 14 items of which each item is scored 0 (not present) to 4 (very severe). | 6 weeks |
| Paranoid Thoughts Scale (PTS) | The PTS is a self-rated scale to assess current paranoia symptoms. The PTS consists of 32 items that the subject rates from 1 (not at all) to 5 (totally). | 6 weeks |
| Treatment Satisfaction Questionnaire for Medication (TSQM) | The TSMQ is a brief questionnaire asking patients about how satisfied they were with the ease, timing, etc. of the study medication giving a good indication of adherence | 6 weeks |
| Childhood Trauma Questionnaire (CTQ) | The CTQ is a validated measure of adverse early experiences characterized on a measure of Anxiety Sensitivity Index and retrospective childhood maltreatment. A 5-point frequency of occurrence scale is utilized: (1) never true, (2) rarely true, (3) sometimes true, (4) often true, and (5) very often true. Each sub-scale score ranges from 5 (no history of abuse or neglect) to 25 (very extreme history of abuse and neglect). | 6 weeks |
| Experience Close Relationships (ECR) | The ECR is a self-rated questionnaire designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure vs. secure about the extent to which their partner's availability and responsiveness) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others vs. secure depending on others) . | 6 weeks |
| Arizona Sexual Experience Scale (ASEX) | The ASEX is a self-rated scale to assess sexual functioning. The ASEX consists of 5 items that the subject will rate from 1 ("extremely strong", "easily", or "satisfying") to 6 ("absent" or "never") based on how he/she feels at the time. | 6 weeks |
| Social Phobia Inventory (SPIN) | The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations. | 6 weeks |
| Penn Emotion Recognition Test (ER-40) | The ER-40 is a computerized emotion discrimination test presenting 40 color photographs of evoked happy, sad, anger, fear and neutral expressions balanced for poser gender and ethnicity. | 6 weeks |
| San Diego |
| California |
| 92103 |
| United States |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
|
| Secondary | Global Assessment of Functioning (GAF) | The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning). | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Clinical Global Impression-Severity of Illness (CGI-S) | The CGI-S is used to evaluate changes in overall severity of illness. Scores range from 1 (not at all) to 7 (among the most extremely ill). | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Clinical Global Impression-Global Improvement (CGI-I) | The CGI-I is a global assessment to evaluate the subject's improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse). | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®) | The CMINDS ® consists of "construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™). | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEITâ„¢ ME) | The MSCEITâ„¢ ME is a multiple choice test that asses how individuals manage their emotions. | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Calgary Depression Scale for Schizophrenia (CDSS) | The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient. | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Hamilton-Anxiety Scale (HAM-A) | The HAM-A is a clinician administered scale for the evaluation of anxiety symptoms. It consists of 14 items of which each item is scored 0 (not present) to 4 (very severe). | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Paranoid Thoughts Scale (PTS) | The PTS is a self-rated scale to assess current paranoia symptoms. The PTS consists of 32 items that the subject rates from 1 (not at all) to 5 (totally). | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Treatment Satisfaction Questionnaire for Medication (TSQM) | The TSMQ is a brief questionnaire asking patients about how satisfied they were with the ease, timing, etc. of the study medication giving a good indication of adherence | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Childhood Trauma Questionnaire (CTQ) | The CTQ is a validated measure of adverse early experiences characterized on a measure of Anxiety Sensitivity Index and retrospective childhood maltreatment. A 5-point frequency of occurrence scale is utilized: (1) never true, (2) rarely true, (3) sometimes true, (4) often true, and (5) very often true. Each sub-scale score ranges from 5 (no history of abuse or neglect) to 25 (very extreme history of abuse and neglect). | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Experience Close Relationships (ECR) | The ECR is a self-rated questionnaire designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure vs. secure about the extent to which their partner's availability and responsiveness) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others vs. secure depending on others) . | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Arizona Sexual Experience Scale (ASEX) | The ASEX is a self-rated scale to assess sexual functioning. The ASEX consists of 5 items that the subject will rate from 1 ("extremely strong", "easily", or "satisfying") to 6 ("absent" or "never") based on how he/she feels at the time. | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Social Phobia Inventory (SPIN) | The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations. | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| Secondary | Penn Emotion Recognition Test (ER-40) | The ER-40 is a computerized emotion discrimination test presenting 40 color photographs of evoked happy, sad, anger, fear and neutral expressions balanced for poser gender and ethnicity. | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 6 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |