Ondansetron Augmentation in Treatment-resistant OCD

Institute of Neuroscience, Florence, Italy

Status and phase: Completed; Phase 4

Conditions: Obsessive Compulsive Disorder

Treatments: Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01303536

OND2

Details and patient eligibility

About

The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms among obsessive compulsive disorder resistant patients.

Enrollment: 21 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• a diagnosis of OCD established by clinical interview with a licensed psychiatrist;
• a score of ≥ 24 at the Yale Brown Obsessive Compulsive Scale
• a Clinical Global Inventory score ≥ 4, after over 12 weeks of treatment with an adequate trial of an selective serotonin reuptake inhibitor at a moderate to high dose

Exclusion criteria

• diagnoses of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, current substance dependence or abuse, and current major depressive episode preceding the onset of obsessive compulsive disorder
• undergoing concomitant behavior therapy
• or having significant cardiovascular, hepatic, renal or pulmonary diseases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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21 participants in 1 patient group

obsessive compulsive disorder

Experimental group

Description:

obsessive compulsive patients resistant to selective serotonin reuptake inhibitor therapy, in addition to their continued stable dose of FDA approved selective serotonin reuptake inhibitors, received oral ondansetron 0.25 mg in two daily administrations (0.5 mg daily) for 2 weeks. Subsequently, the dose was titrated to 0.5 mg in two daily administrations (1 mg/day total) for another 10 weeks. ondansetron was discontinued and the patients were followed for an additional 4 week with biweekly

Treatment:

Drug: Ondansetron