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Administrating Oxytocin to Treat Treatment Schizophrenia and Schizo-affective Patients

NCT01598623 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-11-25

No results posted yet for this study

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.

Conditions

  • Oxytocin + Non Specific Counselling
  • Oxytocin + Social Skills Training
  • Placebo + Non Specific Counselling
  • Placebo + Social Skills Training

Interventions

DRUG

Oxytocin

24 IU Intranasal, three times daily (morning, noon and evening, before meals) for 3 weeks (21 days).

BEHAVIORAL

Social Skills Training

three times a week for three weeks.

BEHAVIORAL

Placebo + Non Specific Counselling

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Mark Weiser, MD · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-02-28
Completion
2014-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01598623 on ClinicalTrials.gov