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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Hamilton Health Sciences Corporation | OTHER |
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This study will examine the efficacy of pregabalin (Lyrica) added to SRI treatment in OCD for individuals who have not responded or only partially responded to an adequate trial of SRI. Although SRIs have demonstrated efficacy in OCD in numerous placebo-controlled trials, response rates have been as low as 40%. Augmentation strategies would be beneficial to maximize treatment response in OCD.
Pregabalin (Lyrica) is an anticonvulsant medication that appears to have a novel mechanism of action. It has been shown to enhance activity at gamma-amino-butyric acid (GABA) receptors as well as inhibit glutamate release. These two neurotransmitters systems have been implicated in the neurobiology of OCD.
The study will consist of patients who have not attained full response to an SRI. The patients will be randomized in a double-blind fashion to augmentation with pregabalin (Lyrica) or placebo. The dose of study medication will be flexible, starting at 75 mg/day and increasing in 75 mg increments to a maximum of 600 mg/day, based on efficacy and any side effects. Patients' response to treatment will be measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the Montgomery Asberg Depression Rating Scale (MADRS), and the Clinical Global Impression Scale(CGI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregabalin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | pregabalin starting at 75 mg/day (at Study Week 0). Doses will be titrated up in 75 mg increments until a clinical response is achieved, as tolerated in the following manner: to 150 mg/day at the end of Study Week 1, to 225 mg/day at the end of Study Week 2, 300 mg/day at the end of Study Week 4, 450 mg/day at the end of Study Week 6 and to 600 mg/day at the end of Study Week 8. The maximum dose of pregabalin will be 600 mg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Yale-Brown-Obsessive-Compulsive-Scale | Baseline(Week 0) and Weeks 5, 9 and 12 (13 weeks) | |
| Clinical Global Impression - Improvement | Weeks 1, 3, 5, 7, 9 and 12 (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery Asberg Depression Rating Scale | Baseline (Week 0) (once - 1 week) | |
| Sheehan Disability Scale | Baseline (Week 0) and Weeks 5, 9 and 12 (13 weeks) | |
| Beck Depression Inventory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Van Ameringen, MD, FRCPC | McMaster Univeristy, Hamilton Health Sciences | Principal Investigator |
| Dan Stein | University of Stellenbosch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MacAnxiety Research Centre | Hamilton | Ontario | L8S 1B7 | Canada |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Placebo | Drug | Placebo starting at 75 mg/day (at Study Week 0). Doses will be titrated up in 75 mg increments until a clinical response is achieved, as tolerated in the following manner: to 150 mg/day at the end of Study Week 1, to 225 mg/day at the end of Study Week 2, 300 mg/day at the end of Study Week 4, 450 mg/day at the end of Study Week 6 and to 600 mg/day at the end of Study Week 8. The maximum dose of pregabalin/placebo will be 600 mg/day. |
|
| Weeks 1, 3, 5, 7, 9 and 12 (13 weeks) |
| Clinical Global Impression - Severity | Baseline (Week 0) and Weeks 1, 3, 5, 7, 9 and 12 (13 weeks) |
| Saving Inventory - Revised | Weeks 1, 5, 9 and 12 (12 weeks) |
| Dimensional Yale-Brown-Obsessive Compulsive Scale (D-Y-BOCS) | Baseline (Week 0) and Weeks 1, 5 and 12 (13 weeks) |
| Padua Inventory | 13 weeks |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |