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Status unknownNCT04177719Updated Aug 31, 2021

Neurobiological Effects of Oxytocin in Schizophrenia

An interventional study of Oxytocin and Placebo in Schizophrenia, sponsored by National Institute of Mental Health and Neuro Sciences, India. Status unknown at 1 site in India. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-31.

Sponsored by National Institute of Mental Health and Neuro Sciences, India · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Schizophrenia

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03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Oxytocin

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

    Drug: Oxytocin

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugOxytocin

    oxytocin will be given intranasally. The order of administration will be counterbalanced

  • DrugPlacebo

    Saline placebo will be given intranasally. The order of administration will be counterbalanced

05

What researchers measure

Primary outcomes

  1. PET

    changes in \[18F\] flumazenil specific binding

    Time frame: 90 minues

  2. fMRI changes

    changes in brain functional connectivity

    Time frame: 90 minutes

  3. MRS

    Changes in brain chemistry measured using MRS

    Time frame: 90 minutes

06

Study locations

1 of 1 sites recruiting
  • National Institute of Mental Health and Neurosciecnes
    Bangalore, Karnataka 560029, India
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04177719
Lead sponsor
National Institute of Mental Health and Neuro Sciences, India
Responsible party
Dr Naren P Rao (Additional Professor of Psychiatry, National Institute of Mental Health and Neuro Sciences, India) — Principal investigator
First posted
Nov 26, 2019
Start date
Nov 8, 2019
Primary completion
Apr 2022 (estimated)
Completion
Apr 2022 (estimated)
Last update
Aug 31, 2021

Study contacts

Naren P Rao, MD
Contact
narenrao@nimhans.ac.in
08026995879

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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