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Break in funding
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The Objective of this study is to investigate the long-term efficacy of intranasal oxytocin in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute being on adequate treatment with antipsychotic medication.
Approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin: 24 IU - 168 IU | Experimental | Oxytocin twice daily for 3 weeks |
|
| Vehicle placebo | Sham Comparator | Placebo for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin: 24IU - 168 IU | Drug | Oxytocin: 24IU - 168 IU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks | 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. | baseline and 28 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). | 28 weeks |
| Clinical Global Impression-Severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center - Hillcrest | San Diego | California | 92103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | This study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The PI has left the institution and this study was terminated due to loss of funding. The age of the participants enrolled cannot be located. |
| 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 28 Weeks | 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 | baseline and 28 weeks |
|
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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 | All Participants | This study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study. |
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This study was halted due to an indefinite break in funding. The Principal Investigator has left the institution and there is no way to determine the arms/groups of this study. The study data was never analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Feifel | UCSD | dfeifel@kadimanp.com |
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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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| Placebo | Drug | placebo drug |
|
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). |
| 28 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). | 28 Weeks |
| Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®) | 28 weeks |
| Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME) | 28 Weeks |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| 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 | 28 weeks |
|
|
| Secondary | Clinical Global Impression-Severity | 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 | 28 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 | 28 Weeks |
|
|
| Secondary | Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®) | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 28 weeks |
|
|
| Secondary | Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME) | The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed. | Posted | 28 Weeks |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |