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Oxytocin Treatment of Schizophrenia

NCT01028677 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-04-18

Study results available
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Summary

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

Participants: Up to 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 social cognitive measures (primary outcomes) and psychiatric symptom ratings (secondary outcomes).

Conditions

Interventions

DRUG

intranasal spray with oxytocin

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

OTHER

nasal spray without oxytocin

6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Cort A Pedersen, M.D. · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-03-31
Completion
2011-03-31

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 NCT01028677 on ClinicalTrials.gov