Oxytocin Treatment of Schizophrenia (OTS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of North Carolina, Chapel Hill.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01028677
First received: December 4, 2009
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, social functioning and decreases paranoia and other psychotic symptoms in schizophrenia.

Participants: 80 adults with schizophrenia for at least one year and with a high rating for paranoia.

Procedures (methods): Oxytocin or placebo will be administered twice daily in an intranasal spray (6 insufflations/dose or 24 IU) for 6 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 and social competence and subjects and an informant will complete ratings of social functioning.


Condition Intervention
Social Cognition Deficits
Social Dysfunction
Paranoia
Schizophrenia
Drug: intranasal oxytocin spray
Other: formulated solution containing all ingredients as Syntocinon Spray except for oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxytocin Treatment of Social Deficits and Paranoia in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • PANSS total and subscores [ Time Frame: 6 week trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social cognition, skill task performance and ratings of social functioning [ Time Frame: 6 week trial ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxytocin
Twice daily oxytocin treatments will be self-administered by subjects.
Drug: intranasal oxytocin spray
6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
Other Name: Syntocinon Spray
Placebo Comparator: control spray
Self administration twice daily of intranasal spray that does not contain oxytocin.
Other: formulated solution containing all ingredients as Syntocinon Spray except for oxytocin
Treatment consists of 6 insufflations (0.1 metered dose/insufflation) twice daily for 6 weeks of a formulated solution that contains all ingredients in Syntocinon Spray except for oxytocin.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meeting DSM-IV criteria for paranoid or undifferentiated schizophrenia for at least 1 year.
  • Scoring > or equal to 4 on the suspiciousness/persecution (paranoia) subscale of the Positive and Negative Symptoms Scale (PANSS), a full PANSS score > or equal to 60: stability of symptom severity and on the same medication(s) and dose(s) for at least 1 month; low to moderate depressive symptoms.

Exclusion Criteria:

  • Low literacy as indicated by an inability to read and understand the consent form.
  • Dependence on substances other than tobacco or caffeine.
  • Positive urine drug screen for illegal substances or drugs that have not been prescribed.
  • Debilitating medical conditions (including AIDS; HIV infection alone will not be grounds for exclusion).
  • Major surgery or trauma in the past year will be grounds for exclusion although subjects determined to be recovered and stable may be included at the discretion of the PI.
  • Pregnancy, breast-feeding.
  • Having given birth in the past 6 months or breast-feeding in the past 3 months.
  • Individuals judged unable to learn self-administration of intranasal treatments and/or not sufficiently reliable to do so will be excluded.
  • Abnormalities found during medical evaluation will be grounds for exclusion although subjects with laboratory measures barely outside the normal range may be included at the discretion of the Principal Investigator.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01028677

Locations
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Cort A Pedersen, M.D. University of North Carolina, Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: Cort Andrew Pedersen, The University of North Carolina, Chapel Hill, Department of Psychiatry
ClinicalTrials.gov Identifier: NCT01028677     History of Changes
Other Study ID Numbers: 07-0879
Study First Received: December 4, 2009
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
oxytocin
social cognition
social skill
social functioning
paranoia
psychotic symptoms
schizophrenia
social deficits
intranasal administration

Additional relevant MeSH terms:
Schizophrenia
Paranoid Disorders
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 October 19, 2014