SchizophreniaNCT04176835
Oxytocin and Social Decision Making in Schizophrenia
A study testing Oxytocin nasal spray in people with Schizophrenia, run by National Institute of Mental Health and Neuro Sciences, India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males between 18 and 45 years with at least 7 years of education
- The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder
- capacity to provide informed consent
- Males between 18 and 45 years with at-least 7 years education
- Capacity to provide informed consent
- absence of past or present psychiatric illnesses including substance abuse/dependence
Who cannot join
- Current comorbid DSM-IV axis I diagnosis
- General impaired intellectual functioning
- history of alcohol or substance abuse or dependence in the last 12 months
- contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- past history of head injury resulting in loss of consciousness or neurosurgery
- concomitant severe medical conditions
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- metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.
- Healthy volunteers:
- General impaired intellectual functioning
- contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- past history of head injury resulting in loss of consciousness or neurosurgery
- concomitant severe medical conditions
- metal implants or paramagnetic objects within the body or claustrophobia which may interfere with the MRI.
- Family history of schizophrenia or schizoaffective or schizophreniform disorder in a first-degree relative
About this study
Official title: Neurobiological Effects of Oxytocin on Social Decision Making in Schizophrenia: A Pharmacological MRI Study
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.
- Conditions
- Schizophrenia
- Being tested
- Oxytocin nasal spray, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Single-dose oxytocin will be administered intranasally
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order Receives: Drug: Oxytocin nasal spray |
| Placebo | Placebo comparator | Single-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI changes with oxytocin while performing ultimatum game and at rest
Changes in brain activity and functional connectivity
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study startApr 2016
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Naren P Rao, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176835
- Sponsor's protocol ID
- 00861
- Status last verified
- Sep 2022
- First submitted
- 22 Nov 2019
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Effects of Oxytocin on Social Decision Making in Schizophrenia: A Pharmacological MRI Study
- ClinicalTrials.gov ID
- NCT04176835
- Acronym / sponsor ID
- 00861
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: Oxytocin nasal spraySingle-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order |
| Placebo | Placebo comparator | Drug: PlaceboSingle-dose intranasal oxytocin or intranasal placebo administered in counterbalanced order |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males between 18 and 45 years with at least 7 years of education
- The DSM-IV diagnosis of Schizophrenia or schizoaffective or schizophreniform disorder
- capacity to provide informed consent
- Males between 18 and 45 years with at-least 7 years education
- Capacity to provide informed consent
Key exclusion criteria (14 listed)
- Current comorbid DSM-IV axis I diagnosis
- General impaired intellectual functioning
- history of alcohol or substance abuse or dependence in the last 12 months
- contraindication to Oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- past history of head injury resulting in loss of consciousness or neurosurgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin nasal spraySingle-dose oxytocin will be administered intranasally | Drug | oxytocin |
| Placebo | Drug | Placebo |
Primary outcome
fMRI changes with oxytocin while performing ultimatum game and at rest
Time frame: 90 minutes
Changes in brain activity and functional connectivity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin nasal spray in people with Schizophrenia, run by National Institute of Mental Health and Neuro Sciences, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI changes with oxytocin while performing ultimatum game and at rest (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.