- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00728923
Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD)
March 30, 2012 updated by: New York State Psychiatric Institute
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Minocycline (NPL-2003)
|
Minocycline (NPL-2003) daily for 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale
Time Frame: 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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale.
Time Frame: 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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D., Columbia-NYSPI-RFMH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
July 31, 2008
First Submitted That Met QC Criteria
August 1, 2008
First Posted (Estimate)
August 6, 2008
Study Record Updates
Last Update Posted (Estimate)
April 2, 2012
Last Update Submitted That Met QC Criteria
March 30, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5707
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obsessive Compulsive Disorder
-
Anne Katrine PagsbergCopenhagen Trial Unit, Center for Clinical Intervention Research; Danish Research...Active, not recruitingObsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceDenmark
-
Baylor College of MedicineRecruitingObsessive-Compulsive Disorder | Cognitive Behavioral Therapy | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceUnited States
-
Chaim HuijserLevvelRecruitingObsessive-Compulsive Disorder | Anxiety Disorders and Symptoms | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceNetherlands
-
Stanford UniversityCompletedObsessive Compulsive DisorderUnited States
-
NYU Langone HealthCompletedObsessive Compulsive DisorderUnited States
-
Massachusetts General HospitalActive, not recruitingObsessive Compulsive DisorderUnited States
-
Boston University Charles River CampusCompletedObsessive Compulsive DisorderUnited States
-
Butler HospitalNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive DisorderUnited States
-
Karolinska InstitutetCompletedObsessive Compulsive DisorderSweden
-
Roseli ShavittCompleted
Clinical Trials on NPL-2003
-
NeuropharmCompleted
-
Catabasis PharmaceuticalsCompleted
-
Catabasis PharmaceuticalsCompletedHypertriglyceridemia | Hyperlipoproteinemia Type I | Lipoprotein Lipase Deficiency, Familial | Chylomicronemia, FamilialCanada
-
Catabasis PharmaceuticalsCompletedMetabolic Diseases | Dyslipidemias | Lipid Metabolism Disorders | Hyperlipidemias | HypertriglyceridemiaUnited States
-
Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Recruiting
-
GlaxoSmithKlineCompleted
-
Medical University of ViennaCytoSorbents, IncCompletedElective Cardiac Surgical InterventionsAustria
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza A Virus InfectionUnited States
-
Medical University of GrazCompletedDiabetes, Type IAustria
-
Catabasis PharmaceuticalsCompletedDyslipidemia | Hypercholesterolemia | HypertriglyceridemiaUnited States, Canada