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Neurobiological Effects of Oxytocin in Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Oxytocin
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. 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

Sites / Locations

  • National Institute of Mental Health and NeurosciecnesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxytocin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

PET
changes in [18F] flumazenil specific binding
fMRI changes
changes in brain functional connectivity
MRS
Changes in brain chemistry measured using MRS

Secondary Outcome Measures

Full Information

First Posted
November 22, 2019
Last Updated
August 30, 2021
Sponsor
National Institute of Mental Health and Neuro Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT04177719
Brief Title
Neurobiological Effects of Oxytocin in Schizophrenia
Official Title
Understanding the Neurobiological Effects of Oxytocin on Social Trust Deficits in Schizophrenia: A Multimodal Imaging - Genetics Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 8, 2019 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

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
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.

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
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
oxytocin will be given intranasally. The order of administration will be counterbalanced
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline placebo will be given intranasally. The order of administration will be counterbalanced
Primary Outcome Measure Information:
Title
PET
Description
changes in [18F] flumazenil specific binding
Time Frame
90 minues
Title
fMRI changes
Description
changes in brain functional connectivity
Time Frame
90 minutes
Title
MRS
Description
Changes in brain chemistry measured using MRS
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: Diagnosis of schizophrenia or schizoaffective disorder Males between 18 and 45 years capacity to provide informed consent Exclusion Criteria: 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 Inclusion Criteria: Males between 18 and 45 years capacity to provide informed consent Exclusion Criteria: 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 on treatment with benzodiazepine medications for at least 8 weeks contraindication to Positron emission tomography Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naren P Rao, MD
Phone
08026995879
Email
narenrao@nimhans.ac.in
Facility Information:
Facility Name
National Institute of Mental Health and Neurosciecnes
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naren P Rao, MD
Phone
08026995879
Email
narenrao@nimhans.ac.in

12. IPD Sharing Statement

Plan to Share IPD
No

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Neurobiological Effects of Oxytocin in Schizophrenia

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