Augmentation in Tx-resistant OCD: an Open Label Trial
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| ClinicalTrials.gov Identifier: NCT00590642 |
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Recruitment Status :
Completed
First Posted : January 10, 2008
Last Update Posted : December 1, 2009
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Sponsor:
Creighton University
Collaborator:
Forest Laboratories
Information provided by:
Creighton University
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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 |
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 |
| 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
MedlinePlus related topics:
Obsessive-Compulsive Disorder
| Group/Cohort |
|---|
| 1 |
Primary Outcome Measures :
- Acamprosate would be efficacious for SSRI resistant OCD symptoms [ Time Frame: Patients will be administered 12 weeks of Acamprosate. ]
Secondary Outcome Measures :
- 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
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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 |
Study Population
Psychiatry clinic
Criteria
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 ClinicalTrials.gov identifier (NCT number): NCT00590642
Locations
| United States, Nebraska | |
| Creighton University Department of Psychiatry | |
| Omaha, Nebraska, United States, 68131 | |
Sponsors and Collaborators
Creighton University
Forest Laboratories
Investigators
| Principal Investigator: | Sriram Ramaswamy, MD | Creighton University |
Publications:
| Responsible Party: | Sriram Ramaswamy, M.D., Creighton University |
| ClinicalTrials.gov Identifier: | NCT00590642 History of Changes |
| 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:
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obsessive compulsive disorder OCD treatment-resistant SSRI |
Additional relevant MeSH terms:
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Compulsive Personality Disorder Obsessive-Compulsive Disorder Personality Disorders Mental Disorders Anxiety Disorders |