OXY-S-01
A Randomized Trial Administering Oxytocin vs Placebo as add-on to Antipsychotics in Patients With Schizophrenia and Schizo-affective Disorder
Sponsor study identifier
interventional
48
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The objectives of the study are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 3, 2012
Actual (reported)May 15, 2012
Actual (reported)February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Total score of structured assessment of social interaction
Change from baseline in the total score of structured assessment of social interaction in Oxytocin compared with placebo on all patients.
Baseline and week 3
Total score of structured assessment of social interaction
Total score of structured assessment of social interaction at week 3
PANSS positive, negative and general psychopathology scales scores
PANSS positive, negative and general psychopathology scales scores at week 1
Total score of structured assessment of social interaction and PANSS scores, genetic and epigenetic status
Total score of structured assessment of social interaction and PANSS scores, genetic and epigenetic status at week 3
Levels of salivary OT,genetic,epigenetic status and total score of structured assessment of social interaction and PANSS scores.
Levels of salivary OT,genetic and epigenetic status at week 3
PANSS positive, negative and general psychopathology scales scores
PANSS positive, negative and general psychopathology scales scores at week 2
24 IU Intranasal, three times daily (morning, noon and evening, before meals) for 3 weeks (21 days).
three times a week for three weeks.
Sheba medical center
Ramat Gan, 52621, Israel
Saporta-Wiesel L, Feldman R, Levi L, Davidson M, Burshtein S, Gur R, Zagoory-Sharon O, Amiaz R, Park J, Davis JM, Weiser M. Intranasal Oxytocin Combined With Social Skills Training for Schizophrenia: An Add-on Randomized Controlled Trial. Schizophr Bull Open. 2024 Oct 21;5(1):sgae022. doi: 10.1093/schizbullopen/sgae022. eCollection 2024 Jan.
Mark Weiser, MD
Sheba Medical Center
First Submitted
May 3, 2012
First Posted
May 15, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 25, 2013
Record last verified: 2013-11
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Source: ClinicalTrials.gov.
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