Skip to content

A study to see if adding ondansetron to fluoxetine helps reduce symptoms of obsessive-compulsive disorder (OCD).

Evaluating The Efficacy And Safety Of Ondansetron As Augmentation Of Fluoxetine In Obsessive-Compulsive Disorder: A Comparative Study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090034
Enrollment
80
Registered
2025-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: F422- Mixed obsessional thoughts and acts

Interventions

Intervention1: Tab Ondansetron: tab ondansetron 4mg-8mg will be given orally in 2 divided dose for 8 weeks Control Intervention1: Tab Fluoxetine: only standard treatment for OCD will be given(Tab Fluo

Sponsors

SN Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient willing to participate in the study and has given written informed consent. 2.Age group 18-60 years. 3.Patients diagnosed with Obsessive-Compulsive Disorder according to DSM-5 TR.(12) 4.Currently na ve or off any psychotropic medication for at least 6 weeks.

Exclusion criteria

Exclusion criteria: 1.Treatment resistant OCD (2 adequate SSRI trial for 12 weeks) 2.History of non response to prior trial of fluoxetine with ondansetron. 3.Patient having severe psychiatric or medical comorbidities except depression. 4.Substance use disorder except nicotine and caffeine. 5.Pregnancy or lactation. 6.Patients with history of adverse reaction to study medications. 7.Inability to provide informed consent. 8.Patient with psychotic symptoms due to other organic illness.

Design outcomes

Primary

MeasureTime frame
Improvement in YBOCS,MADRS,CGI-I, HAM-A ,UKU Scales Timepoint: Improvement in YBOCS,MADRS,CGI-I, HAM-A ,UKU Scales

Secondary

MeasureTime frame
NILTimepoint:

Countries

India

Contacts

Public ContactNidhi Kulhar

SN Medical College Agra

drashutoshkg@gmail.com9837092520

Outcome results

None listed

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