Augmentation in Tx-resistant OCD: an Open Label Trial

November 27, 2009 updated by: Creighton University

Augment in Treatment-resistent Obsessive-compulsive Disorder: an Open-label Trial

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Psychiatry clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acamprosate would be efficacious for SSRI resistant OCD symptoms
Time Frame: Patients will be administered 12 weeks of Acamprosate.
Patients will be administered 12 weeks of Acamprosate.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Collaborators

Forest Laboratories

Investigators

  • Principal Investigator: Sriram Ramaswamy, MD, Creighton University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (ESTIMATE)

January 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 1, 2009

Last Update Submitted That Met QC Criteria

November 27, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMP-MD-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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