Administrating Oxytocin to Treat Treatment Schizophrenia and Schizo-affective Patients

• Status: Unknown status
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of the study are:

1. To evaluate the effect of OT compared to placebo, as add-on to anti-psychotics, on social functioning in schizophrenia.

2. To evaluate the effect of socially oriented CBT administered to patients immediately after they receive OT, compared to patients who receive OT with not-socially oriented CBT, and compared to patients who receive socially oriented CBT without OT. The investigators hypothesize that OT and socially oriented CBT will have a synergistic effect, and will be better than OT or CBT alone.

3. Use a detailed, in depth analysis of social interaction to assess these putative effects of OT. The investigators hypothesize that the use of this analysis will show larger treatment effects of OT than previously shown in less sensitive assessments, such as PANSS.

4. To assess the effect of epigenetic status on response to OT. The investigators hypothesize that epigenetic variants associated with lower OT plasma levels will be associated with greater response to OT treatment.

5. To assess in the relationships between levels of salivary OT and vasopressin, and social interactions in schizophrenia.

6. To assess in the relationships between levels of salivary OT and vasopressin, and response to OT treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

1. Male or female, 18-65 years of age, inclusive

2. Females who are abstinent or practicing an established method of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]).

3. Willing and able to provide informed consent, after the nature of the study has been fully explained

4. Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID.

5. Symptoms: PANSS total score ≤75

6. A score of 4 (moderate) or higher on at least one, or more of the following PANSS negative items: emotional withdrawal, poor rapport, passive-apathetic social withdrawal

7. Receiving the same antipsychotic medication for 2 weeks before randomization.

8. Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission, provided no medication change since hospitalization.

9. Adjunctive treatment with anticholinergic agents, beta-blockers, mood stabilizers, antidepressants; and anxiolytics will be allowed provided that patients have been on the medication for at least 2 weeks prior to entry into the screening phase of the study.

Exclusion Criteria:

1. Unwilling or unable, in the opinion of the Investigator, to comply with study instructions.

2. Pregnant or breast-feeding.

3. Clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).

4. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.

5. Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.

6. Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.

7. Patients with significantly impaired renal or liver function, defined as GOP and or GPT levels >3 times above highest normal value, and or blood creatinine levels above 1.5 will be excluded.