Back to resultsNeurobiological Effects of Oxytocin in Schizophrenia - Imaging Study
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
oxytocin
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
Eligibility Criteria
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
- General impairment in intellectual functioning
- History of alcohol or substance dependence in the last 12 months (with the exception of nicotine)
- 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 50 years
- 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.
Sites / Locations
- National Institute of Mental Health and Neurosciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
oxytocin
Arm Description
All subjects will receive both oxytocin and placebo in a counterbalanced design
Outcomes
Primary Outcome Measures
fMRI changes with oxytocin
changes in functional brain connectivity
Secondary Outcome Measures
Full Information
NCT ID
NCT04158167
First Posted
November 1, 2019
Last Updated
November 6, 2019
Sponsor
National Institute of Mental Health and Neuro Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT04158167
Brief Title
Neurobiological Effects of Oxytocin in Schizophrenia - Imaging Study
Official Title
Neurobiological Effects of Oxytocin on Metacognitive Deficits in Schizophrenia: A Pharmacological - Imaging Genetics Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2013 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (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
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
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
Single Group Assignment
Model Description
After completion of clinical and cognitive assessments, all subjects will undergo a baseline fMRI scan. Later subjects will receive24IU oxytocin and saline placebo in counterbalanced order on two separate days and undergo repeat fMRI scans.
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxytocin
Arm Type
Other
Arm Description
All subjects will receive both oxytocin and placebo in a counterbalanced design
Intervention Type
Drug
Intervention Name(s)
oxytocin
Intervention Description
24 International units of oxytocin or palcebo will be given intranasally. The order of administration will be counterbalanced
Primary Outcome Measure Information:
Title
fMRI changes with oxytocin
Description
changes in functional brain connectivity
Time Frame
Upto 90 minutes after administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
General impairment in intellectual functioning
History of alcohol or substance dependence in the last 12 months (with the exception of nicotine)
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 50 years
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.
Facility Information:
Facility Name
National Institute of Mental Health and Neurosciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560029
Country
India
12. IPD Sharing Statement
Learn more about this trial
Neurobiological Effects of Oxytocin in Schizophrenia - Imaging Study
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