SchizophreniaNCT04177719
Neurobiological Effects of Oxytocin in Schizophrenia
A study testing Oxytocin in people with Schizophrenia, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
Trial 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. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIndia
- Study dates
- 8 Nov 2019to Apr 2022
- 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
- Diagnosis of schizophrenia or schizoaffective disorder
- Males between 18 and 45 years
- capacity to provide informed consent
- Males between 18 and 45 years
- capacity to provide informed consent
Who cannot join
- current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine)
- Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- Contraindication to MRI like implants/claustrophobia
- Past history of head injury resulting in loss of consciousness or neurosurgery
- Concomitant severe medical conditions
- On treatment with benzodiazepine medications for at least 8 weeks
Show all 16Show fewer
- Contraindication to Positron emission tomography
- Healthy volunteers
- Lifetime diagnosis of psychiatric illness including substance dependence
- contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- contraindication to MRI like implants/claustrophobia
- past history of head injury resulting in loss of consciousness or neurosurgery
- concomitant severe medical conditions
- on treatment with benzodiazepine medications for at least 8 weeks
- contraindication to Positron emission tomography
- Family history of schizophrenia, schizoaffective or schizophreniform disorder in family member
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
National Institute of Mental Health and Neurosciecnes
Bangalore, Karnataka, 560029
Naren P Rao, MD, 08026995879, narenrao@nimhans.ac.in
About this study
Official title: Understanding the Neurobiological Effects of Oxytocin on Social Trust Deficits in Schizophrenia: A Multimodal Imaging - Genetics Study
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.
- Conditions
- Schizophrenia
- Being tested
- Oxytocin, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
oxytocin will be given intranasally. The order of administration will be counterbalanced
PlaceboDrug
Saline placebo will be given intranasally. The order of administration will be counterbalanced
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET
changes in [18F] flumazenil specific binding
Measured: 90 minues
fMRI changes
changes in brain functional connectivity
Measured: 90 minutes
MRS
Changes in brain chemistry measured using MRS
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 posted26 Nov 2019
- Study start8 Nov 2019
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
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
- NCT04177719
- Sponsor's protocol ID
- 00908
- Status last verified
- Aug 2021
- First submitted
- 22 Nov 2019
- Last updated
- 31 Aug 2021
- 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Neurobiological Effects of Oxytocin on Social Trust Deficits in Schizophrenia: A Multimodal Imaging - Genetics Study
- ClinicalTrials.gov ID
- NCT04177719
- Acronym / sponsor ID
- 00908
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 26 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinSingle-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced |
| Placebo | Placebo comparator | Drug: PlaceboSingle-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- Males between 18 and 45 years
- capacity to provide informed consent
- Males between 18 and 45 years
- capacity to provide informed consent
Key exclusion criteria (16 listed)
- current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine)
- Contraindication to oxytocin like hypersensitivity, vascular disease, chronic nephritis, epilepsy, asthma
- Contraindication to MRI like implants/claustrophobia
- Past history of head injury resulting in loss of consciousness or neurosurgery
- Concomitant severe medical conditions
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 |
|---|---|---|
| Oxytocinoxytocin will be given intranasally. The order of administration will be counterbalanced | Drug | Oxytocin |
| PlaceboSaline placebo will be given intranasally. The order of administration will be counterbalanced | Drug | Placebo |
Primary outcome
PET
Time frame: 90 minues
changes in [18F] flumazenil specific binding
fMRI changes
Time frame: 90 minutes
changes in brain functional connectivity
MRS
Time frame: 90 minutes
Changes in brain chemistry measured using MRS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Schizophrenia, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naren P Rao, MD (08026995879, narenrao@nimhans.ac.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET (time frame: 90 minues). The study lists 3 primary outcomes in all. 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 31 Aug 2021.