Oxytocin Treatment of Social Cognitive and Functional Deficits in Schizophrenia (OTS-12WK)

This study is currently recruiting participants.
Verified February 2014 by University of North Carolina, Chapel Hill
Sponsor:
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: February 3, 2014
Last verified: February 2014
  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 2015
Estimated Primary Completion Date: January 2015 (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 (including dialysis, 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: February 3, 2014
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 April 17, 2014