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

NCT01275248 | Terminated Phase 2 DMC

• 1 other identifier: OND-003
• Study Type: interventional
• Target: 130
• Locations: 2 countries
• Sites: 32

Brief 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

Keywords

OCD; Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (2)

• Core Period: Change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total at Month 3 score

  Day -1 (baseline), Month 3

• Extension Period: Participants with Safety Adverse Experiences

  up to Month 33

Secondary Outcomes (3)

• Core Period: Participants Considered Responders as Measured by the Clinical Global Impression-Improvement (CGI-I) Score

  Month 3

• Core Period: Change from Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Month 3

  Day -1 (baseline), Month 3

• Core Period: Change from Baseline in the Sheehan Disability Scale (SDS) Score at Month 3

  Day -1 (baseline), Month 3

Study Arms (3)

Ondansetron 0.5 mg

EXPERIMENTAL

Ondansetron oral tablet 0.5 mg taken twice a day in addition to a serotonin reuptake inhibitor (SRI) for 12 weeks in the core period and for up to 30 months in the extension period.

Drug: Ondansetron

Ondansetron 0.75 mg

EXPERIMENTAL

Ondansetron oral tablet 0.75 mg taken twice a day in addition to a serotonin reuptake inhibitor (SRI) for 12 weeks in the core period and for up to 30 months in the extension period.

Drug: Ondansetron

Placebo

PLACEBO COMPARATOR

Placebo oral tablet taken twice a day in addition to a serotonin reuptake inhibitor (SRI) for 12 weeks in the core period and for up to 30 months in the extension period.

Drug: Placebo

Interventions

Ondansetron DRUG

Oral tablets in 0.5mg or 0.75mg strength

Also known as: Ondansetron HCl

Ondansetron 0.5 mg; Ondansetron 0.75 mg

Placebo DRUG

Oral tablet to match the experimental interventions

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults 18 years of age or older
• Able to understand the study and provide informed consent
• Subjects who are fluent in English and/or Spanish (speaking, writing, and reading)
• Willing and able to comply with the requirements of the protocol and follow directions from the clinic staff
• Body mass index (BMI) ≤ 40 kg/m\^2 (wearing indoor clothing without shoes)
• For all females: Female patients will be included if they are post-menopausal for at least two years or sterilized, or if they are of childbearing potential, they are not breastfeeding, their pregnancy test is negative, they have no intention of becoming pregnant during the course of the study, and are using adequate contraceptive drugs or devices. Medically acceptable methods of contraception that may be used by the patient and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization or abstinence. Females using oral contraception must have started using the medication at least 8 weeks prior to screening. Surgical sterilization must have occurred at least 6 weeks prior to screening.
• Documented diagnosis of Obsessive-Compulsive Disorder (OCD) as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
• At screening, documented history of stable and current regimen of one of the following five serotonin reuptake inhibitor (SRI) for at least 6 weeks prior to screening at the minimum daily dosage listed:
• clomipramine (Anafranil®) 150 mg
• fluvoxamine (Luvox®) 200 mg or fluvoxamine CR (Luvox CR®) 200 mg
• fluoxetine (Prozac®) 40 mg
• paroxetine (Paxil®) 40 mg (does not include paroxetine CR (Paxil CR®))
• sertraline (Zoloft®) 100 mg
• Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score of ≥ 24
• Hamilton Depression Rating Scale (HAM-D) score of \< 20

You may not qualify if:

• Presence of significant medical illnesses such as, but not restricted to, cardiovascular, (including congestive heart failure and bradyarrhythmias), endocrine or intestinal disorders that would interfere with the conduct of the study
• History of significant head injury, other significant brain trauma, or seizure disorder (not including a single childhood febrile seizure)
• Clinically significant abnormal findings on physical examination
• Positive pregnancy test
• Subjects who intend to donate blood or blood components while receiving study drug or within 1 month of the completion of treatment
• Hoarding as the primary Obsessive-Compulsive Disorder (OCD) symptom (secondary hoarding will be allowed)
• Obsessive-compulsive spectrum disorder as a primary disorder (secondary obsessive-compulsive spectrum disorders will be allowed)
• Requiring active behavioral therapy during the study period (run-in and treatment periods). Patients with a history of behavioral therapy may be enrolled as long as they will not be actively engaged in behavioral therapy during the study. However, booster sessions, occurring no more than quarterly (before and after the core study), are allowed. Supportive and other forms of psychotherapy will be permitted during the study as long as the patient has been engaged in such therapy for at least 8 weeks prior to study enrollment and there are no changes during the study.
• Mental retardation or an IQ less than 70
• The following comorbid psychiatric conditions identified by current or past medical history or as a result of the Mini-International Neuropsychiatric Interview (MINI) or Structured Clinical Interview for DSM-IV-TR Axis II Personality Disorders (SCID-II) psychiatric interviews will be excluded:
• Schizophrenia or other psychotic disorders
• Schizotypal personality disorder
• Bipolar disorder
• Gilles de la Tourette syndrome
• Autism and autistic spectrum disorders

Sponsors & Collaborators

• Transcept Pharmaceuticals: lead

Study Sites (32)

Southwestern Research, Inc.

Beverly Hills, California, 90210, United States

Location

Sun Valley Research Center

Imperial, California, 92251, United States

Location

Pacific Institute for Medical Research

Los Angeles, California, 90024, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

University of South Florida

St. Petersburg, Florida, 33701, United States

Location

Emory University

Atlanta, Georgia, 30306, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Beacon Clinical Research, LLC

New Bedford, Massachusetts, 02740, United States

Location

Ambulatory Research Center, Dept of Psychiatry

Minneapolis, Minnesota, 55454, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

Biobehavioral Institute, Hofstra

Great Neck, New York, 11021, United States

Location

Eastside Comprehensive Medical Center, LLC

New York, New York, 10021, United States

Location

Columbia University Medical Center NYS Psychiatric Institute

New York, New York, 10032, United States

Location

Montefiore Medical Center, Child Psychiatry Annex

The Bronx, New York, 10467, United States

Location

Richard H. Weisler, MD, PA, and Associates

Raleigh, North Carolina, 27609, United States

Location

Quest Therapeutics of Avon Lake

Avon Lake, Ohio, 44012, United States

Location

Lindner Center of HOPE University of Cincinnati

Mason, Ohio, 45040, United States

Location

The Body Dysmorphic Disorder (BDD) Program

Providence, Rhode Island, 02903, United States

Location

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229, United States

Location

Dean Foundation

Middleton, Wisconsin, 53562, United States

Location

The Rogers Center for Research and Training

Milwaukee, Wisconsin, 53227, United States

Location

Grupo de Estudios Medicos y Familiares

Mexico City, Federal District, 03740, Mexico

Location

Instituto Mexicano de Investigacion Clinica S.A. de C.V. (IMIC)

Mexico City, Federal District, 06700, Mexico

Location

Hospital Aranda de la Parra S.A. de C.V.

León, Guanajuato, 37000, Mexico

Location

Estudios Integrales en Salud Mental, S.C.

Guadalajara, Jalisco, 44670, Mexico

Location

CIT Neuropsique

Monterrey, Nuevo León, 64020, Mexico

Location

Centro par alas Adicciones y Salud Mental S.A.

Monterrey, Nuevo León, 64060, Mexico

Location

Instituto de Informacion e Investigacion en Salud Mental, A.C. (INFOSAME)

Monterrey, Nuevo León, 64710, Mexico

Location

Hospital Lomas de San Luis Internacional

San Luis Potosí City, San Luis Potosí, 78218, Mexico

Location

Instituto para el Fortalecimiento de Capacidades en Salud

Tlalnepantla, State of Mexico, 54050, Mexico

Location

Instituto para el Fortalecimiento de Capacidades en Salud: Focus Salud Mexico S.C.

Mérida, Yucatán, 97130, Mexico

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

• Eric Hollander, MD

  Montefiore Medical Center, Bronx, NY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 12, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

US (22); ME (10)