Trial Outcomes & Findings for Pilot Study of Minocycline (NPL-2003) in Adults With Obsessive-Compulsive Disorder (OCD) (NCT NCT00728923)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

12 weeks

Results posted on

2012-04-02

Participant Flow

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

Participant milestones

Participant milestones
Measure	Minocycline minocycline 100mg bid for 12 weeks
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Minocycline n=9 Participants minocycline 100mg bid for 12 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	37 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Minocycline n=9 Participants 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).
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale	2 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Minocycline n=9 Participants 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).
Number of Patients That Met Response Criteria for the Hamilton Depression Rating Scale.	0 participants

Adverse Events

Minocycline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carolyn Rodriguez

New York State Psychiatric Institute

Phone: 212-543-5637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place