Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: NPL-2003
Intervention description: Minocycline (NPL-2003) daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: OCD

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.
    

Eligibility 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