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Oxytocin Treatment of Social Cognitive and Functional Deficits in Schizophrenia

NCT01394471 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2015-06-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Intranasal Oxytocin Spray

6 insufflations (24IU of oxytocin total) given twice daily for 12 weeks

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Cort A Pedersen, MD · University of North Carolina, Chapel Hill

  • David L Penn, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394471 on ClinicalTrials.gov