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Efficacy and Safety Study of Low-Dose Ondansetron For Adjunctive Therapy In Adult Patients With Obsessive-Compulsive Disorder

NCT01275248 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2013-01-18

No results posted yet for this study

Summary

This study is to assess the efficacy and safety of two doses of ondansetron (0.5 mg and 0.75 mg) relative to placebo when administered twice daily as adjunctive therapy for adult patients with Obsessive-Compulsive Disorder (OCD) who have not adequately responded to treatment with a serotonin reuptake inhibitor (SRI).

Conditions

  • Obsessive-compulsive Disorder

Interventions

DRUG

Ondansetron

Oral tablets in 0.5mg or 0.75mg strength

DRUG

Placebo

Oral tablet to match the experimental interventions

Sponsors & Collaborators

  • Transcept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Eric Hollander, MD · Montefiore Medical Center, Bronx, NY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States
  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01275248 on ClinicalTrials.gov