Back to resultsOxytocin 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
About this trial
This is an interventional other trial for Schizophrenia
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
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
NCT ID
NCT04176835
First Posted
November 22, 2019
Last Updated
September 27, 2022
Sponsor
National Institute of Mental Health and Neuro Sciences, India
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
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