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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has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.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

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

This study's planned enrollment of 44 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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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

Exclusion Criteria:

  1. current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine)
  2. to oxytocin like , 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

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

06

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

07

Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2019 (actual). Primary completion is estimated for Apr 2022, 29 months after the start.

Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 29 months is below that.

Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 22, 2019
First posted
Nov 26, 2019
StartActual
Nov 8, 2019
Primary completionEst.
Apr 2022
CompletionEst.
Apr 2022
Last update
Aug 31, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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