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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014