Trial Outcomes & Findings for A 10 Week Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Memantine(Namenda) as Augmentation Therapy in Patients With Generalized Anxiety Disorder (NCT NCT00411398)

Results Overview

Standard Clinical Depression Rating Scale. Clinician administered. Scale units are points/numbers. Possible range is 0 to 44 with the latter signifying more severe anxiety

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

15 participants

Primary outcome timeframe

10 wk

Results posted on

2014-12-10

Participant Flow

subjects were recruited easily by radio and newspaper advertisements

Participant milestones

Participant milestones
Measure	Memantine Memantine tablets
Overall Study STARTED	15
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A 10 Week Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Memantine(Namenda) as Augmentation Therapy in Patients With Generalized Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Memantine n=15 Participants Memantine tablets
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 wk

Population: LOCF if at least one post baseline visit completed

Standard Clinical Depression Rating Scale. Clinician administered. Scale units are points/numbers. Possible range is 0 to 44 with the latter signifying more severe anxiety

Outcome measures

Outcome measures
Measure	Memantine n=10 Participants Memantine tablets
Hamilton Anxiety Scale	10.9 units on a scale Standard Deviation 2.04

Adverse Events

Memantine

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Memantine n=15 participants at risk Memantine tablets
Gastrointestinal disorders nausea	20.0% 3/15 • Number of events 3
Nervous system disorders headache	20.0% 3/15 • Number of events 3
General disorders Fatigue	13.3% 2/15 • Number of events 2
Skin and subcutaneous tissue disorders Edema	6.7% 1/15 • Number of events 1

Additional Information

Thomas Schwartz

SUNY Upstate

Phone: 3154643166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place