Neurobiological Effects of Oxytocin in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-01

Study Completion Date

2018-12-30

Brief Summary

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To investigate whether 24IU oxytocin can result in changes in functional brain connectivity in patients with schizophrenia and healthy individuals using functional magnetic resonance imaging (fMRI). The study will also examine the effect of oxytocin receptor gene polymorphism on the functional connectivity

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

After completion of clinical and cognitive assessments, all subjects will undergo a baseline fMRI scan. Later subjects will receive24IU oxytocin and saline placebo in counterbalanced order on two separate days and undergo repeat fMRI scans.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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oxytocin

All subjects will receive both oxytocin and placebo in a counterbalanced design

Group Type OTHER

oxytocin

Intervention Type DRUG

24 International units of oxytocin or palcebo will be given intranasally. The order of administration will be counterbalanced

Interventions

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oxytocin

24 International units of oxytocin or palcebo will be given intranasally. The order of administration will be counterbalanced

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. General impairment in intellectual functioning
2. History of alcohol or substance dependence in the last 12 months (with the exception of nicotine)
3. Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
4. Past history of head injury resulting in loss of consciousness or neurosurgery
5. Concomitant severe medical conditions
6. Metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.

Healthy volunteers:

1. Males between 18 and 50 years

Exclusion Criteria

Schizophrenia subjects:

1\) Life-time diagnosis of psychiatric illnesses including substance abuse 2) General impairment in intellectual functioning 3) Past history of head injury resulting in loss of consciousness or neurosurgery 4) Concomitant severe medical or neurological conditions 5) Metal implants or paramagnetic objects or claustrophobia 6) Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member (sibling, parent or offspring) 7) Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes