Augmentation in Tx-resistant OCD: an Open Label Trial
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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. |
ClinicalTrials.gov Identifier: NCT00590642 |
Recruitment Status :
Completed
First Posted : January 10, 2008
Last Update Posted : December 1, 2009
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Condition or disease |
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Obsessive Compulsive Disorder |
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 |

Group/Cohort |
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1 |
- Acamprosate would be efficacious for SSRI resistant OCD symptoms [ Time Frame: Patients will be administered 12 weeks of Acamprosate. ]
- Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD. [ Time Frame: Patients will be administered 12 weeks of Acamprosate ]

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Ages Eligible for Study: | 19 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00590642
United States, Nebraska | |
Creighton University Department of Psychiatry | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Sriram Ramaswamy, MD | Creighton University |
Responsible Party: | Sriram Ramaswamy, M.D., Creighton University |
ClinicalTrials.gov 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 |
obsessive compulsive disorder OCD treatment-resistant SSRI |
Compulsive Personality Disorder Obsessive-Compulsive Disorder Personality Disorders Mental Disorders Anxiety Disorders |