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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

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Apr 2016, registered Nov 2019).
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

In context

Schizophrenia

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

This study's enrollment of 55 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. Males between 18 and 45 years with at least 7 years of education
  2. The diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder
  3. capacity to provide

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. to Oxytocin like , 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
Terms in these criteria, in plain language(4)

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.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

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
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

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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.

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

Ran from Apr 2016 to primary completion in Sep 2019, 41 months.

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 41 months is above 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 25, 2019
StartActual
Apr 2016
Primary completionActual
Sep 2019
CompletionActual
Sep 2019
Last update
Sep 29, 2022
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 Sep 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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 ↗

Not currently enrolling

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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Discussion

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