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

Obsessive Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728923
• Other study ID #: 5707
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2008
• Last updated: March 30, 2012
• Start date: August 2008
• Est. completion date: July 2011

Study information

• Verified date: March 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• NPL-2003
Minocycline (NPL-2003) daily for 12 weeks

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No
Secondary	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.	12 weeks	No

External Links

•   Columbia University Obsessive-Compulsive Disorder Research Clinic