Oxytocin Treatment of Social Cognitive and Functional Deficits in Schizophrenia (OTS-12WK)
This study is currently recruiting participants.
Verified March 2013 by University of North Carolina, Chapel Hill
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Information provided by (Responsible Party):
Cort Pedersen, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01394471
First received: July 11, 2011
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, psychotic symptoms and social functioning in schizophrenia.
Participants: 80 adults with schizophrenia or schizoaffective disorder for at least one year.
Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray for 12 weeks. Before, during and at the end of the trial, each subject will undergo psychiatric symptom ratings and tests of mental abilities used in social functioning, cognition, and social competence.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder |
Drug: Intranasal Oxytocin Spray |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Oxytocin Treatment of Social Cognitive and Functional Deficits in Schizophrenia |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Change in social cognition scores from baseline to 6 and 12 week time points [ Time Frame: Baseline, Week 6, and Week 12 visits ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in social functioning measures from baseline to 6 and 12 week time points [ Time Frame: Baseline, Week 6, and Week 12 visits ] [ Designated as safety issue: No ]
- Change in PANSS total and subscale scores from baseline to 6 and 12 week time points. [ Time Frame: Baseline, Week 6 and Week 12 visits ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: oxytocin
Twice daily treatment of oxytocin will be administered by subjects
|
Drug: Intranasal Oxytocin Spray
6 insufflations (24IU of oxytocin total) given twice daily for 12 weeks
Other Name: Syntocinon spray
|
|
Placebo Comparator: Control spray
Self administration twice daily of intranasal spray that does not contain oxytocin
|
Drug: Intranasal Oxytocin Spray
6 insufflations (24IU of oxytocin total) given twice daily for 12 weeks
Other Name: Syntocinon spray
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18-65 yrs of age;
- currently meeting DSM-IV criteria for schizophrenia or schizoaffective disorder with onset occurring > 1 year prior to enrollment in the study;
- score of <24 on the Reading the Mind in the Eyes Test ("Eyes Test", Baron-Cohen, et al 2001), which represents 0.5 SD below the mean in a large normative sample OR
- get a minimum score of "3" on at least two of the following "social" items on the PANSS ratings: suspiciousness/persecution (ideation), hostility, passive/apathetic social withdrawal, uncooperativeness, active social avoidance,
- stable symptoms as well as being on the same medication and psychosocial therapy regimen for > 1 month.
Exclusion Criteria:
- current or lifetime history of schizoaffective (bipolar type), delusional, other psychotic (shared, substance-induced, due to a medical disorder) disorders, bipolar, cyclothymic, somatoform, dissociative, eating or personality disorders, unipolar major depressive episodes with psychotic features, dementia;
- history of mania or hypomania within the past two years
- substance use or abuse disorder during the past 3 months (except tobacco, caffeine);
- treatment currently or within the past 6 months with high dose sedative-hypnotics, stimulants, chronic glucocorticoids (other medications that are adequately controlling acute or chronic disorders [e.g., hypertension, diabetes, hypo or hyperthyroidism, asthma, allergies, mild infections etc.] are allowed);
- debilitating or inadequately controlled medical conditions (HIV infection without AIDS is not exclusionary);
- major surgery/trauma in the past 4 months;
- pregnancy, childbirth or breast-feeding in the past year;
- significant physical exam, laboratory or EKG abnormalities;
- reading level < 5th grade on the Wide Range Achievement Test (WRAT, Wilkinson 1993);
- inability to read English well enough to complete study questionnaires.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394471
Locations
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Cort A Pedersen, MD 919-966-4447 cort_pedersen@med.unc.edu | |
| Contact: Tonya L Elliott, MS 919-966-3915 tlelliot@med.unc.edu | |
| Principal Investigator: Cort A Pedersen, MD | |
| Principal Investigator: David L Penn, Ph.D. | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
| Principal Investigator: | Cort A Pedersen, MD | University of North Carolina, Chapel Hill |
| Principal Investigator: | David L Penn, PhD | University of North Carolina, Chapel Hill |
More Information
Publications:
Randolph, C. (1998). Repeatable Battery for the Assessment of Neuropsychological Status Manual. San Antonio, TX: Psychological Corporation.
| Responsible Party: | Cort Pedersen, MD, Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01394471 History of Changes |
| Other Study ID Numbers: | 11-0259, R01MH093529 |
| Study First Received: | July 11, 2011 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
schizophrenia schizoaffective disorder oxytocin OT social cognition social functioning |
paranoia psychosis psychotic symptoms social deficits intranasal administration |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Oxytocin |
Oxytocics Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013