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

NCT00728923 | Completed Phase 2 Results DMC

• 1 other identifier: 5707
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale.

  12 weeks

Study Arms (1)

1

EXPERIMENTAL

Minocycline (NPL-2003)

Drug: NPL-2003

Interventions

NPL-2003 DRUG

Minocycline (NPL-2003) daily for 12 weeks

Also known as: 5707 (Insitution Code name)

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related 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.

  PMID: 20923629 RESULT

Related Links

• Columbia University Obsessive-Compulsive Disorder Research Clinic

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Carolyn Rodriguez
• Organization: New York State Psychiatric Institute

cr2163@columbia.edu

212-543-5637

Study Officials

• Carolyn I. Rodriguez, M.D., Ph.D.

  Columbia-NYSPI-RFMH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 6, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: April 2, 2012
• Results First Posted: April 2, 2012

Record last verified: 2012-03

Locations

US (1)