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OpenTrials
Completed

NCT Number: NCT00796497

Ondansetron in Treatment Resistant Obsessive Compulsive Disorder (OCD)

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Neuroscience

Florence, Italy, 50122

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults aged 18 to 55
  • 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

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

Treatment and study plan

ondansetron

Drug

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.

Other names: Zofran

Primary outcomes

  1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: 6th 12th week

Secondary outcomes

  1. clinical global impression (CGI)

    Time frame: 6th e 12th

Sponsors and collaborators

Lead sponsor

Institute of Neuroscience, Florence, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 24, 2008
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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