Antipsychotic Effects of Oxytocin
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Antipsychotic Effects of Oxytocin|
- Change in Total score in the Positive and Negative Syndrome Scale (PANSS)from baseline to endpoint [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
- Global Assessment of Functioning (GAF) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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).
- Clinical Global Impression-Severity of Illness (CGI-S) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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).
- Clinical Global Impression-Global Improvement (CGI-I) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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).
- Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The CMINDS ® consists of "construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™).
- Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The MSCEIT™ ME is a multiple choice test that asses how individuals manage their emotions.
- Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient.
- Hamilton-Anxiety Scale (HAM-A) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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).
- Paranoid Thoughts Scale (PTS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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).
- Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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
- Childhood Trauma Questionnaire (CTQ) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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).
- Experience Close Relationships (ECR) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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) .
- Arizona Sexual Experience Scale (ASEX) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
- Social Phobia Inventory (SPIN) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations.
- Penn Emotion Recognition Test (ER-40) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2011|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Oxytocin: Low Dose
42 IU BID for the six weeks
42 IU BID for six weeks
Experimental: Oxytocin: High Dose
84 IU BID for six weeks
84 IU BID for six weeks
|Placebo Comparator: Placebo||
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621737
|United States, California|
|University of California, Irvine|
|Irvine, California, United States, 92037|
|University of California, San Diego|
|San Diego, California, United States, 92103|
|Principal Investigator:||David Feifel, MD, Ph.D||UCSD|
|Principal Investigator:||Steven Potkin, MD||UCI|