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Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study we are recruiting patients to receive the drug NPL-2003, which is thought to modulate the neurotransmitter glutamate, added to whatever other OCD medications they are taking in a 12-week open label study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Minocycline (NPL-2003) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPL-2003 | Drug | Minocycline (NPL-2003) daily for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale | Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 30% reduction on the YBOCS. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale. | Patients given HAM-D (Hamilton Depression Scale), a measure of depressive symptoms. For the HAM-D the minimum units are 0 and Maximum units on the total scale are 50. The higher the number on the HAM-D, the more severe the symptoms. Response was defined as at least a 30% reduction on the HAM-D. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn I. Rodriguez, M.D., Ph.D. | Columbia-NYSPI-RFMH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20923629 | Result | Rodriguez CI, Bender J Jr, Marcus SM, Snape M, Rynn M, Simpson HB. Minocycline augmentation of pharmacotherapy in obsessive-compulsive disorder: an open-label trial. J Clin Psychiatry. 2010 Sep;71(9):1247-9. doi: 10.4088/JCP.09l05805blu. |
| Label | URL |
|---|---|
| Columbia University Obsessive-Compulsive Disorder Research Clinic | View source |
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Adult outpatients were recruited from the community starting August 2008 until July 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Minocycline | minocycline 100mg bid for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Minocycline | minocycline 100mg bid for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale | Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 30% reduction on the YBOCS. | Posted | Aug 2011 | Number | participants | 12 weeks |
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Minocycline | minocycline 100mg bid for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Rodriguez | New York State Psychiatric Institute | 212-543-5637 | cr2163@columbia.edu |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale. | Patients given HAM-D (Hamilton Depression Scale), a measure of depressive symptoms. For the HAM-D the minimum units are 0 and Maximum units on the total scale are 50. The higher the number on the HAM-D, the more severe the symptoms. Response was defined as at least a 30% reduction on the HAM-D. | Posted | Number | participants | 12 weeks |
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| 9 |
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| 9 |
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