A Clinical trial to study the effects of Intranasal Oxytocin Therapy for Treatment of Negative Symptoms in Schizophrenia

Adjunctive Intranasal Oxytocin Therapy for Treatment of Negative Symptoms in Schizophrenia: A DTI Study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060817

Enrollment

Registered

2023-12-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F209- Schizophrenia, unspecified Health Condition 2: F203- Undifferentiated schizophrenia

Interventions

Intervention1: Intranasal Oxytocin: Patients will be divided into two groups, Group 1 and Group 2. Group 1 will receive Intranasal Oxytocin as adjunct to ongoing treatment for period of 1 week at dose

Eligibility

Inclusion criteria

Inclusion criteria: 1) Schizophrenia diagnosed patients according to The ICD 11 Classification of Mental and Behavioural Disorders, Diagnostic criteria for research. 2) 20–55 years of age. 3) Disease course >2years. 4) PANSS negative symptoms score =4 in at least four items or =15 combined. 5) PANSS positive symptoms score=4 in at least three items or =10 combined. 8 6) CDSS score 7) Patients receiving treatment for schizophrenia with preferably second generation anti-psychotic 8) No substance use or addiction (except nicotine and caffeine) 9) No medical co-morbidities. 10) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine. 2) Significant medical or neurological illness including severe cardiovascular, hepatic, renal, [serum creatinine > 1.5 mg/dl], anaemia [Haemoglobin 3) History of substantial brain damage or any neurological disorders. 4) Pregnancy 5) Allergic rhinitis or other inflammation of nasal mucosa for past 6 months 6) Patients receiving treatment with any first-generation anti-psychotic/depot or long-acting anti-psychotic/anti-depressant. 7) Not willing to give written informed consent.

Design outcomes

Primary

Measure	Time frame
Reduction in scores of Negative symptoms of Schizophrenia as rated by Positive and Negative Syndrome scale - Negative Syndrome scale (PANSS-NSS), Positive and Negative Syndrome Scale - Factor Score for Negative Symptoms (PANSS- FSNS) and Scale for the Assessment of Negative Symptoms (SANS) after Intranasal Oxytocin treatment.Timepoint: 1, 2, 3 and 4 weeks	—

Secondary

Measure	Time frame
Changes in Fractional Anisotropy(FA) as measured by DTI after Intranasal Oxtytocin treatment.Timepoint: 1 week	—

Countries

India

Contacts

Public ContactDr Anjanik Kumar Rajan

Central Institute of Psychiatry

dranjanikkumarcip@gmail.com7766817961

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026