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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	NPL-2003	Minocycline (NPL-2003)

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale	12 weeks	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

Name	Time	Method
Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale.	12 weeks	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.