Trial Outcomes & Findings for Memantine Treatment for Obsessive-compulsive Disorder and Generalized Anxiety Disorder (NCT NCT00674219)

Results Overview

Participants in the OCD group were rated using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a standard measure of obsessive-compulsive disorder (OCD) severity in pharmacotherapy studies. It is administered by a trained rater. It comprises 10 items assessing OCD symptoms (e.g. time spent, degree of control, severity). Each item is scored on a scale from 0 (not present) to 4 (severe) \[total score range = 0-40\] over the previous week. The higher the number on the Y-BOCS, the more severe the symptoms. Participants in the GAD group were rated using the Hamilton Anxiety Rating Scale (HARS), a standard measure of anxiety severity in pharmacotherapy studies. It is administered by a trained rater. It comprises 14 items assessing anxiety symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

17 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2019-05-10

Participant Flow

Participants were recruited during 2007-2008 from the Anxiety Disorders Program at UCLA.

Participant milestones

Participant milestones
Measure	OCD Group Persons meeting inclusion criteria for a diagnosis of obsessive-compulsive disorder.	GAD Group Persons meeting inclusion criteria for a diagnosis of generalized anxiety disorder.
Overall Study STARTED	10	7
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Memantine Treatment for Obsessive-compulsive Disorder and Generalized Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OCD Group n=10 Participants Persons meeting inclusion criteria for a diagnosis of obsessive-compulsive disorder	GAD Group n=7 Participants Persons meeting inclusion criteria for a diagnosis of generalized anxiety disorder	Total n=17 Participants Total of all reporting groups
Age, Continuous	38.6 years n=5 Participants	37 years n=7 Participants	37.9 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Diagnosis of OCD or GAD	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Participants in the OCD group were rated using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a standard measure of obsessive-compulsive disorder (OCD) severity in pharmacotherapy studies. It is administered by a trained rater. It comprises 10 items assessing OCD symptoms (e.g. time spent, degree of control, severity). Each item is scored on a scale from 0 (not present) to 4 (severe) \[total score range = 0-40\] over the previous week. The higher the number on the Y-BOCS, the more severe the symptoms. Participants in the GAD group were rated using the Hamilton Anxiety Rating Scale (HARS), a standard measure of anxiety severity in pharmacotherapy studies. It is administered by a trained rater. It comprises 14 items assessing anxiety symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Outcome measures

Outcome measures
Measure	OCD Group n=10 Participants Persons meeting inclusion criteria for a diagnosis of OCD.	GAD Group n=7 Participants Persons meeting inclusion criteria for a diagnosis of GAD.
Psychometric Scores 12 weeks	16.4 units on a scale Standard Deviation 13.6	18.86 units on a scale Standard Deviation 4.14
Psychometric Scores Baseline	27.6 units on a scale Standard Deviation 4.4	24.3 units on a scale Standard Deviation 1.7

Adverse Events

OCD Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

GAD Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	OCD Group n=10 participants at risk OCD group - received 12 weeks of open-label memantine 10 mg twice daily, as either mono therapy or augmentation of their existing medication. Memantine: Namenda 10mg BID for 12 weeks	GAD Group n=7 participants at risk GAD group - received 12 weeks of open-label memantine 10 mg twice daily, as either mono therapy or augmentation of their existing medication. Memantine: Namenda 10mg BID for 12 weeks
Nervous system disorders dizziness	30.0% 3/10 • Number of events 3 • 12 weeks	42.9% 3/7 • Number of events 3 • 12 weeks
Nervous system disorders Somnolence	20.0% 2/10 • Number of events 3 • 12 weeks	14.3% 1/7 • Number of events 2 • 12 weeks

Additional Information

Alexander Bystritsky MD PhD

UCLA Department of Psychiatry

Phone: (310) 206-5133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place