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

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NPL-2003
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring OCD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Minocycline (NPL-2003)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 31, 2008
Last Updated
March 30, 2012
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00728923
Brief Title
Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD)
Official Title
Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
OCD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Minocycline (NPL-2003)
Intervention Type
Drug
Intervention Name(s)
NPL-2003
Other Intervention Name(s)
5707 (Insitution Code name)
Intervention Description
Minocycline (NPL-2003) daily for 12 weeks
Primary Outcome Measure Information:
Title
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale.
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn I. Rodriguez, M.D., Ph.D.
Organizational Affiliation
Columbia-NYSPI-RFMH
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20923629
Citation
Rodriguez CI, Bender J Jr, Marcus SM, Snape M, Rynn M, Simpson HB. Minocycline augmentation of pharmacotherapy in obsessive-compulsive disorder: an open-label trial. J Clin Psychiatry. 2010 Sep;71(9):1247-9. doi: 10.4088/JCP.09l05805blu.
Results Reference
result
Links:
URL
http://www.columbia-ocd.org
Description
Columbia University Obsessive-Compulsive Disorder Research Clinic

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

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