Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

Ondansetron Augmentation in Treatment Resistant Obsessive Compulsive Disorder: A Preliminary Single-Blind Prospective Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00796497

Enrollment

Registered

2008-11-24

Start date

2008-03-31

Completion date

2008-12-31

Last updated

2011-02-24

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

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder, 5-ht3, ondansetron

Brief summary

Given that 5-HT3 receptors are indirect inhibitors of cortico-mesolimbic DA release, the 5-HT3 receptor antagonist ondansetron augmentation might potentially have efficacy in the treatment of resistant Obsessive Comulsive Disorder (OCD) patients on combined SRIs and antipsychotics.

Detailed description

METHOD: Fourteen patients with a DSM-IV diagnosis of treatment resistant OCD, under stable treatment with SSRI's and neuroleptic augmentation will enter an 12-week single blind trial of ondansetron initiated at a dose of 0.25 mg twice daily for 6 weeks, that will be titrated to 0.5 mg twice daily for 6 weeks.

Interventions

DRUGondansetron

ondansetron hydrochloride (oral solution) dosage of 0.25 mg twice a day for 6 weeks followed by 0,5 mg twice a day for 6 weeks for a total observation period of 12 weeks.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

1. adults aged 18 to 55 2. a Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of ≥ 20 after ≥ 12 weeks of treatment with an established effective dose of an Selective Serotonin Reuptake Inhibitors or clomipramine and after ≥ 10 weeks of augmentation treatment with antipsychotics (risperidone at least 2 mg/day quetiapine at least 150 mg/day; olanzapine at least 5mg/day; haloperidol titrated at least 10 mg/day; aripiprazole at least 10 mg/day)

Exclusion criteria

1. a history of alcohol or substance abuse 2. current severe depressive symptoms, bipolar disorder, panic disorder, schizophrenia, or other psychiatric conditions 3. heart disease, arrhythmia, liver problems, including cirrhosis, seizures, glaucoma or serious medical disease 4. hoarding as only Obsessive Compulsive symptom 5. women of childbearing potential not using a medically acceptable contraceptive method.

Design outcomes

Primary

Measure	Time frame
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	6th 12th week

Secondary

Measure	Time frame
clinical global impression (CGI)	6th e 12th

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026