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

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00728923
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 35
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder	Drug: NPL-2003	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD)
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Minocycline (NPL-2003)	Drug: NPL-2003; Minocycline (NPL-2003) daily for 12 weeks; Other Names: 5707 (Insitution Code name)

Outcome Measures

Primary Outcome Measures

1. Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale [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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute

Investigators

• Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D., Columbia-NYSPI-RFMH

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Columbia University Obsessive-Compulsive Disorder Research Clinic

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00728923
• Other Study ID Numbers: 5707
• First Posted: Aug 6, 2008
• Last Update Posted: Apr 2, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by New York State Psychiatric Institute: OCD
• Additional relevant MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder

Study Results

Participant Flow

Recruitment Details	Adult outpatients were recruited from the community starting August 2008 until July 2011.

Arm/Group Title	Minocycline
Arm/Group Description	minocycline 100mg bid for 12 weeks
Period Title: Overall Study
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Minocycline
Arm/Group Description	minocycline 100mg bid for 12 weeks
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37 (15)
Sex: Female, Male (Count of Participants)
Female	3 33.3%
Male	6 66.7%
Region of Enrollment (participants) [Number]
United States	9 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Minocycline
Arm/Group Description	Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
Measure Participants	9
Number [participants]	2 22.2%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Minocycline
Arm/Group Description	Subjects received minocycline at 50mg BID (twice daily) for 3 days and then at 100mg BID for 12 weeks in addition to their SRI (serotonin reuptake inhibitor).
Measure Participants	9
Number [participants]	0 0%

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Minocycline
Arm/Group Description	minocycline 100mg bid for 12 weeks
All Cause Mortality
	Minocycline
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Minocycline
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	Minocycline
	Affected / at Risk (%)	# Events
Total	0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.