Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD)
This study has been completed.
Sponsor:
New York State Psychiatric Institute
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00728923
First received: July 31, 2008
Last updated: March 30, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive Compulsive Disorder |
Drug: NPL-2003 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD) |
Resource links provided by NLM:
Further study details as provided by New York State Psychiatric Institute:
Primary Outcome Measures:
- Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 9 |
| Study Start Date: | August 2008 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Minocycline (NPL-2003)
|
Drug: NPL-2003
Minocycline (NPL-2003) daily for 12 weeks
Other Name: 5707 (Insitution Code name)
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Primary DSM-IV Diagnosis of OCD
- Currently on a stable and adequate dose of SRI (or history of prior SRI or CBT treatment meeting criteria for adequate trial)
- Patients not currently receiving an SRI or CBT will be included if they have undergone a prior SRI or CBT trial and they report no interest in pursuing another DRI or CBT trial at this time. Patients who have been on SRIs in the past must be free of SRIs for at least 6 weeks prior to participation
- Y-BOCS score of greater or equal to 16
- Physically health and females must be using effective contraception
- Sufficient severity of symptoms to warrant additional augmentation treatment
- Able to provide consent
Exclusion Criteria:
- Ongoing treatment with other antibiotics and/or Accutane. Patients with lupus erythematosus
- Patients planning to start CBT during the study period or those who have begun CBT within the past 8 weeks
- Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder or other psychotic disorder
- Current major depressive disorder (patients must be free of the disorder for 3 months prior to enrollment). HAM-D must be <18.
- Judged clinically to be at risk of suicide (suicidal ideation, severe depression or other factors
- Current eating disorder
- Severe renal insufficiency
- Documented history of hypersensitivity or intolerance to tetracycline antibiotics
- Concomitant use of anti-coagulant drugs, antacids, iron, calcium, magnesium, aluminum, zinc sales. Note:Concomitant psychotropic medications such as antipsychotics and benzodiazepines will be permitted as long as they have been stable for at least 4 weeks and remain stable during the course of the study.
- Current ETOH/drug abuse or dependence disorder of dependency in the past 3 months
- Female patients who are either pregnant or nursing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728923
Locations
| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
| Principal Investigator: | Carolyn I. Rodriguez, M.D., Ph.D. | Columbia-NYSPI-RFMH |
More Information
Additional Information:
Publications:
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00728923 History of Changes |
| Other Study ID Numbers: | 5707 |
| Study First Received: | July 31, 2008 |
| Results First Received: | August 29, 2011 |
| Last Updated: | March 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York State Psychiatric Institute:
|
OCD |
Additional relevant MeSH terms:
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Minocycline |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013