Neurobiological Effects of Oxytocin in Schizophrenia - Imaging Study

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: oxytocin

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560029
      • National Institute of Mental Health and Neurosciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion and 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: oxytocin; All subjects will receive both oxytocin and placebo in a counterbalanced design	Drug: oxytocin; 24 International units of oxytocin or palcebo 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
fMRI changes with oxytocin	changes in functional brain connectivity	Upto 90 minutes after administration

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

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: 00807

Drug and device information, study documents

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