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CompletedNCT04176835Updated Sep 29, 2022

Oxytocin and Social Decision Making in Schizophrenia

An interventional study of Oxytocin nasal spray and Placebo in Schizophrenia, sponsored by National Institute of Mental Health and Neuro Sciences, India. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-29.

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

Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Male
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Study 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.

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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. Males between 18 and 45 years with at least 7 years of education
  2. The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder
  3. capacity to provide informed consent

Exclusion Criteria:

  1. Current comorbid DSM-IV axis I diagnosis
  2. General impaired intellectual functioning
  3. history of alcohol or substance abuse or dependence in the last 12 months
  4. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
  5. past history of head injury resulting in loss of consciousness or neurosurgery
  6. concomitant severe medical conditions
  7. 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 45 years with at-least 7 years education
  2. Capacity to provide informed consent
  3. absence of past or present psychiatric illnesses including substance abuse/dependence

Exclusion criteria:

  1. General impaired intellectual functioning
  2. contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
  3. past history of head injury resulting in loss of consciousness or neurosurgery
  4. concomitant severe medical conditions
  5. metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.
  6. Family history of schizophrenia or schizoaffective or schizophreniform disorder in a first-degree relative
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    oxytocin

    Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order

    Drug: Oxytocin nasal spray

  • Placebo comparator
    Placebo

    Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order

    Drug: Placebo

Interventions

  • DrugOxytocin nasal spray

    Single-dose oxytocin will be administered intranasally

  • DrugPlacebo
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What researchers measure

Primary outcomes

  1. fMRI changes with oxytocin while performing ultimatum game and at rest

    Changes in brain activity and functional connectivity

    Time frame: 90 minutes

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT04176835
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 25, 2019
Start date
Apr 2016
Primary completion
Sep 2019
Completion
Sep 2019
Last update
Sep 29, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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