search
Back to results

Oxytocin and Social Decision Making in Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxytocin nasal spray
Placebo
Sponsored by
National Institute of Mental Health and Neuro Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Schizophrenia group -

Inclusion Criteria:

  1. Males between 18 and 45 years with at least 7 years of education
  2. The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder
  3. capacity to provide informed consent

Exclusion Criteria:

  1. Current comorbid DSM-IV axis I diagnosis
  2. General impaired intellectual functioning
  3. history of alcohol or substance abuse or dependence in the last 12 months
  4. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
  5. past history of head injury resulting in loss of consciousness or neurosurgery
  6. concomitant severe medical conditions
  7. 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 45 years with at-least 7 years education
  2. Capacity to provide informed consent
  3. absence of past or present psychiatric illnesses including substance abuse/dependence

Exclusion criteria:

  1. General impaired intellectual functioning
  2. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
  3. past history of head injury resulting in loss of consciousness or neurosurgery
  4. concomitant severe medical conditions
  5. metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.
  6. Family history of schizophrenia or schizoaffective or schizophreniform disorder in a first-degree relative

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    oxytocin

    Placebo

    Arm Description

    Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order

    Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order

    Outcomes

    Primary Outcome Measures

    fMRI changes with oxytocin while performing ultimatum game and at rest
    Changes in brain activity and functional connectivity

    Secondary Outcome Measures

    Full Information

    First Posted
    November 22, 2019
    Last Updated
    September 27, 2022
    Sponsor
    National Institute of Mental Health and Neuro Sciences, India
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04176835
    Brief Title
    Oxytocin and Social Decision Making in Schizophrenia
    Official Title
    Neurobiological Effects of Oxytocin on Social Decision Making in Schizophrenia: A Pharmacological MRI Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    September 2019 (Actual)
    Study Completion Date
    September 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Institute of Mental Health and Neuro Sciences, India

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    schizophrenia patients and healthy volunteers will be included. 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 fMRI scans. In one scan subjects will receive a single dose of intranasal oxytocin and in another scan, they will receive intranasal saline. The order of administration of oxytocin or saline will be counterbalanced so that they are not administered in the same order to all subjects. Subjects will be blind to the drug administered.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    oxytocin
    Arm Type
    Experimental
    Arm Description
    Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin nasal spray
    Intervention Description
    Single-dose oxytocin will be administered intranasally
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    fMRI changes with oxytocin while performing ultimatum game and at rest
    Description
    Changes in brain activity and functional connectivity
    Time Frame
    90 minutes

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Schizophrenia group - Inclusion Criteria: Males between 18 and 45 years with at least 7 years of education The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder capacity to provide informed consent Exclusion Criteria: Current comorbid DSM-IV axis I diagnosis General impaired intellectual functioning history of alcohol or substance abuse or dependence in the last 12 months 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: Males between 18 and 45 years with at-least 7 years education Capacity to provide informed consent absence of past or present psychiatric illnesses including substance abuse/dependence Exclusion criteria: General impaired intellectual functioning 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. Family history of schizophrenia or schizoaffective or schizophreniform disorder in a first-degree relative

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Oxytocin and Social Decision Making in Schizophrenia

    We'll reach out to this number within 24 hrs