Neurobiological Effects of Oxytocin in Schizophrenia - Imaging Study

NCT04158167 | Completed

• 1 other identifier: 00807
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• fMRI changes with oxytocin

  changes in functional brain connectivity

  Upto 90 minutes after administration

Study Arms (1)

oxytocin

OTHER

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

Drug: oxytocin

Interventions

oxytocin DRUG

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

oxytocin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Schizophrenia subjects:
• 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:
• Males between 18 and 50 years
• \) 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.

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead

Study Sites (1)

National Institute of Mental Health and Neurosciences

Bangalore, Karnataka, 560029, India

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 8, 2019
• Study Start: September 1, 2013
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

IN (1)