Neurobiological Effects of Oxytocin on Metacognitive Deficits in Schizophrenia: A Pharmacological - Imaging Genetics Study

National Institute of Mental Health and Neuro Sciences, India1 site in 1 country90 target enrollmentSeptember 1, 2013

ConditionsSchizophrenia

Interventionsoxytocin

Drugsoxytocin

Overview

Phase: Not Applicable
Intervention: oxytocin
Conditions: Schizophrenia
Sponsor: National Institute of Mental Health and Neuro Sciences, India
Enrollment: 90
Locations: 1
Primary Endpoint: fMRI changes with oxytocin
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 1, 2013

End Date

December 30, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

National Institute of Mental Health and Neuro Sciences, India

Responsible Party

Principal Investigator

Dr Naren P Rao

Additional Professor

National Institute of Mental Health and Neuro Sciences, India

Eligibility Criteria

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