Ondansetron Augmentation in Treatment-resistant OCD

NCT01303536 | Completed Phase 4 DMC

• 1 other identifier: OND2
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (9)

• Yale Brown Obsessive Compulsive Scale

  baseline

• Yale Brown Obsessive Compulsive Scale

  week 2

• Yale Brown Obsessive Compulsive Scale

  week 4

• Yale Brown Obsessive Compulsive Scale

  week 6

• Yale Brown Obsessive Compulsive Scale

  week 8

• Yale Brown Obsessive Compulsive Scale

  week 10

• Yale Brown Obsessive Compulsive Scale

  week 12

• Yale Brown Obsessive Compulsive Scale

  week 14

• Yale Brown Obsessive Compulsive Scale

  week 16

Secondary Outcomes (9)

• The Drug Effect scale

  week 0

• The Drug Effect scale

  week 2

• The Drug Effect scale

  week 4

• The Drug Effect scale

  week 6

• The Drug Effect scale

  week 8

Study Arms (1)

obsessive compulsive disorder

EXPERIMENTAL

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

Drug: Ondansetron

Interventions

Ondansetron DRUG

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

obsessive compulsive disorder

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Neuroscience, Florence, Italy: lead

Study Sites (1)

Institute of Neuroscience

Florence, Florence, 50137, Italy

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Stefano Pallanti, MD

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: December 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 24, 2011

Record last verified: 2011-02

Locations

IT (1)