Neurobiological Effects of Oxytocin in Schizophrenia

NCT ID: NCT04177719

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-08
• Study Completion Date: 2022-04-30

Brief 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Oxytocin

Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

oxytocin will be given intranasally. The order of administration will be counterbalanced

Placebo

Single-dose oxytocin or placebo will be given intranasally on separate scan days. The order of administration will be counterbalanced

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Saline placebo will be given intranasally. The order of administration will be counterbalanced

Interventions

Oxytocin

oxytocin will be given intranasally. The order of administration will be counterbalanced

Intervention Type: DRUG

Placebo

Saline placebo will be given intranasally. The order of administration will be counterbalanced

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of schizophrenia or schizoaffective disorder

2. Males between 18 and 45 years

3. capacity to provide informed consent

1. Males between 18 and 45 years

2. capacity to provide informed consent

Exclusion Criteria

1. current comorbid axis I diagnosis and no alcohol/substance abuse/dependence in the last 12 months (except nicotine)

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

Healthy volunteers

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Dr Naren P Rao

Additional Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Institute of Mental Health and Neurosciecnes

Bangalore, Karnataka, India

Site Status: RECRUITING

Countries

India

Central Contacts

Naren P Rao, MD

Role: CONTACT

narenrao@nimhans.ac.in

08026995879

Facility Contacts

Naren P Rao, MD

Role: primary

narenrao@nimhans.ac.in

08026995879

Other Identifiers

00908

Identifier Type: -

Identifier Source: org_study_id