Neurobiological Effects of Oxytocin in Schizophrenia - Imaging Study

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Drug: oxytocin

• Registration Number: NCT04158167
• Lead Sponsor: National Institute of Mental Health and Neuro Sciences, India

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-01
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2019-11
• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-06
• Last Update Submitted: 2019-11-06
• Study First Posted: 2019-11-08
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Schizophrenia subjects:

Inclusion criteria 1) Males between 18 and 50 years 2) Diagnosis of DSM-IV schizophrenia, schizoaffective or schizophreniform disorder 3) capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research Exclusion 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:

Inclusion criteria

1. Males between 18 and 50 years
2. Capacity to provide informed consent Exclusion criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
fMRI changes with oxytocin	Upto 90 minutes after administration	changes in functional brain connectivity

Trial Locations

Locations (1)

National Institute of Mental Health and Neurosciences; 🇮🇳 Bangalore, Karnataka, India