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More info
You can access this
clinical trial
if you have
Oxytocin + Non Specific Counselling, Oxytocin + Social Skills Training, Placebo + Non Specific Counselling or Placebo + Social Skills Training
and you are
between 18 and 65
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: Oxytocin
  • Behavioral: Social Skills Training
  • Behavioral: Placebo + Non Specific Counselling

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01598623. The sponsor of the trial is Sheba Medical Center and it is looking for 48 volunteers for the current phase.
Official trial title:
A Randomized Trial Administering Oxytocin vs Placebo as add-on to Antipsychotics in Patients With Schizophrenia and Schizo-affective Disorder