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Neurobiological Effects of Oxytocin in Schizophrenia - Imaging Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158167
Recruitment Status : Completed
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Naren P Rao, National Institute of Mental Health and Neuro Sciences, India

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: oxytocin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Neurobiological Effects of Oxytocin on Metacognitive Deficits in Schizophrenia: A Pharmacological - Imaging Genetics Study
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Oxytocin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. fMRI changes with oxytocin [ Time Frame: Upto 90 minutes after administration ]
    changes in functional brain connectivity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

  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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158167


Locations
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India
National Institute of Mental Health and Neurosciences
Bangalore, Karnataka, India, 560029
Sponsors and Collaborators
National Institute of Mental Health and Neuro Sciences, India
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Responsible Party: Dr Naren P Rao, Additional Professor, National Institute of Mental Health and Neuro Sciences, India
ClinicalTrials.gov Identifier: NCT04158167    
Other Study ID Numbers: 00807
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs