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Oxytocin Treatment of Schizophrenia (OTS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by University of North Carolina, Chapel Hill.
Recruitment status was:  Active, not recruiting
Information provided by:
University of North Carolina, Chapel Hill Identifier:
First received: December 4, 2009
Last updated: September 7, 2012
Last verified: September 2012

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
Drug: intranasal oxytocin spray
Other: formulated solution containing all ingredients as Syntocinon Spray except for oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

Secondary Outcome Measures:
  • Social cognition, skill task performance and ratings of social functioning [ Time Frame: 6 week trial ]

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


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01028677

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
Principal Investigator: Cort A Pedersen, M.D. University of North Carolina, Chapel Hill
  More Information

Additional Information:
Responsible Party: Cort Andrew Pedersen, The University of North Carolina, Chapel Hill, Department of Psychiatry Identifier: NCT01028677     History of Changes
Other Study ID Numbers: 07-0879
Study First Received: December 4, 2009
Last Updated: September 7, 2012

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

Additional relevant MeSH terms:
Paranoid Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Reproductive Control Agents
Physiological Effects of Drugs processed this record on March 29, 2017