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

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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NPL-2003

Drug

Minocycline (NPL-2003) daily for 12 weeks

Other names: 5707 (Insitution Code name)

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2011
First posted: Aug 6, 2008
Registry last updated: Apr 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed