Neurobiological Effects of Oxytocin in Schizophrenia

NCT04177719 | Unknown

• 1 other identifier: 00908
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

22 male patients with schizophrenia and 22 male healthy volunteers will be included in the study. Subjects who meet the inclusion and exclusion criteria for the study will be recruited. After completion of clinical assessments and neuropsychological assessments, all subjects will undergo two multi-modal imaging sessions. In one scan they will receive intranasal oxytocin and in another scan will receive intranasal saline as control. The order of administration of the medication will be counterbalanced and subjects will be blind to the medication administered. Using the simultaneous PET-MRI scanner, PET and fMRI data will be collected simultaneously. Blood will be collected for analysis of oxytocin receptor gene polymorphism and its potential effect on brain activity.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (3)

• PET

  changes in \[18F\] flumazenil specific binding

  90 minues

• fMRI changes

  changes in brain functional connectivity

  90 minutes

• MRS

  Changes in brain chemistry measured using MRS

  90 minutes

Study Arms (2)

Oxytocin

EXPERIMENTAL

Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced

Drug: Placebo

Interventions

Oxytocin DRUG

oxytocin will be given intranasally. The order of administration will be counterbalanced

Oxytocin

Placebo DRUG

Saline placebo will be given intranasally. The order of administration will be counterbalanced

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia or schizoaffective disorder
• Males between 18 and 45 years
• capacity to provide informed consent

You may not qualify if:

• current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine)
• Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
• Contraindication to MRI like implants/claustrophobia
• Past history of head injury resulting in loss of consciousness or neurosurgery
• Concomitant severe medical conditions
• On treatment with benzodiazepine medications for at least 8 weeks
• Contraindication to Positron emission tomography
• Healthy volunteers
• Males between 18 and 45 years
• capacity to provide informed consent
• Lifetime diagnosis of psychiatric illness including substance dependence
• contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
• contraindication to MRI like implants/claustrophobia
• past history of head injury resulting in loss of consciousness or neurosurgery
• concomitant severe medical conditions

Sponsors & Collaborators

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

Study Sites (1)

National Institute of Mental Health and Neurosciecnes

Bangalore, Karnataka, 560029, India

RECRUITING

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

Central Study Contacts

Naren P Rao, MD

CONTACT

08026995879; narenrao@nimhans.ac.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor of Psychiatry

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: November 8, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)