Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Augmentation in Tx-resistant OCD: an Open Label Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00590642
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : December 1, 2009
Forest Laboratories
Information provided by:
Creighton University

Brief Summary:
This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large percentage of patients fail to respond to medications and have residual symptoms. Such patients are referred to as having treatment resistant OCD.

Condition or disease
Obsessive Compulsive Disorder

Detailed Description:
A patient will receive study drug for about 12 weeks. Throughout the study, the study doctor, on best medical judgment, may gradually increase or decrease the dose of the study medication. The adjustments will dependent on the subject's response and whether the subject has side effects. Once the subject has completed treatment under this study, the subject may resume standard treatment for his/her obsessive compulsive disorder by their regular doctor.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Augment in Treatment-resistent Obsessive-compulsive Disorder: an Open-label Trial
Study Start Date : April 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Acamprosate would be efficacious for SSRI resistant OCD symptoms [ Time Frame: Patients will be administered 12 weeks of Acamprosate. ]

Secondary Outcome Measures :
  1. Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD. [ Time Frame: Patients will be administered 12 weeks of Acamprosate ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Psychiatry clinic

Inclusion Criteria:

  • Men and women between 19-55 years of age
  • have dx of OCD as determined by the structured clinical interview for DSM-IV axis 1 disorders
  • SSRI resistant patients with OCD
  • Subjects who are able to comprehend and satisfactorily comply with protocol requirements and have ability to read and write English.
  • Signed written informed consent prior to entering any study procedures.
  • Concomitant psychotropic medications permitted only if prescribed at stable dose for at least 1 month before screening visit

Exclusion Criteria:

  • Patients with concurrent DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders
  • Patients with concurrent DSM-IV diagnosis of mental retardation
  • Patients with concurrent DSM-IV diagnosis of lifetime schizophrenia and other psychotic disorders
  • Patients with concurrent DSM-IV diagnosis of lifetime bipolar disorder
  • Substance dependence or abuse (excluding nicotine) within 6 months prior to screening visit
  • Patients with score of less than 16 on Y-BCOS during screening.
  • Patients with history of intolerance or hypersensitivity to acamprosate.
  • Patients based on history or mental status exam have significant risk fo committing suicide.
  • Patients who are homicidal or violent.
  • Patients with severe renal impairment
  • Female patients who are pregnant or lactating
  • Subjects with history of psychosurgery for OCD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00590642

Layout table for location information
United States, Nebraska
Creighton University Department of Psychiatry
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Forest Laboratories
Layout table for investigator information
Principal Investigator: Sriram Ramaswamy, MD Creighton University

Layout table for additonal information
Responsible Party: Sriram Ramaswamy, M.D., Creighton University Identifier: NCT00590642    
Other Study ID Numbers: CMP-MD-14
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009
Keywords provided by Creighton University:
obsessive compulsive disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders