Neurobiological Effects of Oxytocin in Schizophrenia

Understanding the Neurobiological Effects of Oxytocin on Social Trust Deficits in Schizophrenia: A Multimodal Imaging - Genetics Study

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Oxytocin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naren P Rao, MD; Phone Number: 08026995879; Email: narenrao@nimhans.ac.in

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560029
      • Recruiting
      • National Institute of Mental Health and Neurosciecnes
      • Contact: Naren P Rao, MD; Phone Number: 08026995879; Email: narenrao@nimhans.ac.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Schizophrenia group

Inclusion Criteria:

1. Diagnosis of schizophrenia or schizoaffective disorder
2. Males between 18 and 45 years
3. capacity to provide informed consent

Exclusion Criteria:

1. current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine)
2. Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
3. Contraindication to MRI like implants/claustrophobia
4. Past history of head injury resulting in loss of consciousness or neurosurgery
5. Concomitant severe medical conditions
6. On treatment with benzodiazepine medications for at least 8 weeks
7. Contraindication to Positron emission tomography

Healthy volunteers

Inclusion Criteria:

1. Males between 18 and 45 years
2. capacity to provide informed consent

Exclusion Criteria:

1. Lifetime diagnosis of psychiatric illness including substance dependence
2. contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
3. contraindication to MRI like implants/claustrophobia
4. past history of head injury resulting in loss of consciousness or neurosurgery
5. concomitant severe medical conditions
6. on treatment with benzodiazepine medications for at least 8 weeks
7. contraindication to Positron emission tomography
8. Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxytocin; Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced	Drug: Oxytocin; oxytocin will be given intranasally. The order of administration will be counterbalanced
Placebo Comparator: Placebo; Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced	Drug: Placebo; Saline placebo will be given intranasally. The order of administration will be counterbalanced

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2019
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 00908 (Other Identifier: Funder)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No