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Sponsors and Collaborators: |
University of Maryland National Institute on Drug Abuse (NIDA) |
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Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00884897 |
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 | Intervention | Phase |
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Social Cognition Social Anxiety Emotional Intelligence |
Drug: Oxytocin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Oxytocin and Social Cognition in Schizophrenia |
Estimated Enrollment: | 30 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Oxytocin: Experimental
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.
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Drug: Oxytocin
Oxytocin given as 20 IU BID
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Placebo: Placebo Comparator
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.
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Drug: Placebo
Placebo given as 20 IU BID
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
All participants must:
Exclusion criteria:
Participants will be excluded if they have evidence of:
Pregnancy, planning to become pregnant, or breastfeeding. In addition, women of childbearing age are required to use an effective form of birth control for the duration of the study. Effective forms of birth control include:
Justification: Inflammation of nasal mucosa could interfere with mucosal absorption of intranasally administered OT. Current rhinitis from an upper respiratory infection should be resolved prior to enrollment in study.
Contact: Ann Kearns, BS | 410-402-6854 | akearns@mprc.umaryland.edu |
Contact: Stephanie Feldman, LCSWC | 410-402-6885 | sfeldman@mprc.umaryland.edu |
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 | Maryland Psychiatric Research Center |
Responsible Party: | University of Maryland, Maryland Psychiatric Research Center ( Deanna L. Kelly, Pharm.D., BCPP ) |
Study ID Numbers: | HP-00041024 |
Study First Received: | April 20, 2009 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00884897 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Social Cognition Shcizophrenia Oxytocin |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Oxytocin |
Schizophrenia Oxytocics Mental Disorders Therapeutic Uses Physiological Effects of Drugs |
Reproductive Control Agents Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features Oxytocin |