Oxytocin and Social Cognition in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00884897|
Recruitment Status : Completed
First Posted : April 21, 2009
Results First Posted : June 1, 2017
Last Update Posted : October 2, 2019
Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in patients with schizophrenia and these are not remediated by antipsychotic medications or psychosocial interventions. Social cognition is associated with functional outcome, an important step in striving for recovery in this population. The hormone and neurotransmitter, oxytocin, which has been associated with social bonding and trust has been shown to improve measures of some aspects of social cognition in humans. The study will assess the effect of acute administration of intranasal oxytocin on measures of social cognition and functioning as well as on emotional intelligence and symptoms.
Study population: The study population will include patients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6 weeks. We will enroll a total of 30 subjects (N=15 placebo and N=15 oxytocin groups).
Experimental design and methods: After a one week lead in phase, participants will undergo 3 weeks of oxytocin (20 IU BID) or placebo administration (double blind) in addition to their existing medication regimen. Outcome measures will be administered during the lead in phase, and at the end of the study drug administration phase (under the acute effect of OT). The primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Maryland Assessment of Social Competence (MASC). Secondary measures include rating from the domains of social cognition (emotion perception, attributional style, theory of mind and social perception), symptom rating and measures of social anxiety and quality of life. Side effects and symptoms will be measured weekly.
|Condition or disease||Intervention/treatment||Phase|
|Social Cognition Social Anxiety Emotional Intelligence||Drug: Oxytocin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Oxytocin and Social Cognition in Schizophrenia|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Oxytocin given as 20 IU BID
Placebo Comparator: Placebo
We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.
Placebo given as 20 IU BID
- To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients [ Time Frame: participants are assessed at baseline and end point ]Mayer-Salovay Caruso Emotional Intelligence Test (Mayer et al., 2002; MSCEIT) This is a self report instrument that consists of 141 items and 8 ability subscales, which assess four components (branches) of emotion processing: identifying emotions, using emotions, understanding emotions, and managing emotions. For this study we will focus on the managing emotions and understanding emotions components. There are 29 total items assessed with a total score ranging from 5-145. The higher the score the better the outcome.
- To Determine Whether OT Improves Measures of Social Anxiety. [ Time Frame: Outcomes are compared between Baseline and endpoint ]To determine whether OT improves measures of social anxiety as measured by the Social Interaction Anxiety Scale. This assessment has 20 items scored 0-4 for a total minimum score of 0 and maximum score of 80. The lower the score the better the outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884897
|United States, Maryland|
|Maryland Psychiatric Research Center (MPRC) Outpatient Research Program (ORP); the MPRC Treatment Research Program (TRP)|
|Catonsville, Maryland, United States, 21228|
|Principal Investigator:||Deanna L Kelly, Pharm.D, BCPP||University of Maryland, College Park|
|Principal Investigator:||Mary Lee, MD||National Institute on Drug Abuse (NIDA)|