Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD)

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD)

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Drug: NPL-2003


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Minocycline (NPL-2003) | Drug: NPL-2003<br>* Minocycline (NPL-2003) daily for 12 weeks<br>* Other names: 5707 (Insitution Code name);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD