Effect of Ondansetron in Obsessive Compulsive Disorder

A Study of Ondansetron Add-on to Fluoxetine in Obsessive Compulsive Disorder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009896

Enrollment

Registered

2017-09-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Obsessive Compulsive Disorder

Interventions

Intervention1: Fluoxetine and Ondansetron: 40 to 80 mg per day for 12 weeks and 2 mg BD for 12 weeks respectively Control Intervention1: placebo: Empty capsule

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 to 50 years. 2. Written informed consent from Patient. 3. Diagnosis of OCD as per ICD- 10, DCR. 4. CGI-S score >= 4 ( moderately ill)

Exclusion criteria

Exclusion criteria: 1. Any other comorbid psychiatric disorders except depression and nicotine dependence. 2. Treatment resistant OCD. (>=2 SSRIs trial) 3. History of intolerance to Fluoxetine. 4. History of non-response to prior trial of Fluoxetine with Ondansetron. 5. Use of psychotropic medications within 8 weeks of the screening visit. 6. Patients having clinically significant medical co-morbidity or taking treatment for same. 7. Any clinically significant abnormality in baseline investigation (Hb, TLC, DLC, RBS, S.Urea, S.Creatinine, LFT) 8. Pregnant and lactating females.

Design outcomes

Primary

Measure	Time frame
Yale brown obsessive compulsive scaleTimepoint: at 12 week	—

Secondary

Measure	Time frame
SOFAS, WHOQOL-BREFTimepoint: at 12 week	—

Countries

India

Contacts

Public ContactJamshed Ahmad

King Georges Medical University, Lucknow

an.kgmu@gmail.com9935719000

Outcome results

None listed

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