Trial Outcomes & Findings for Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults (NCT NCT00183729)

NCT ID: NCT00183729

Last Updated: 2018-01-17

Results Overview

Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 35 participants
• Primary outcome timeframe: week 0, week 12
• Results posted on: 2018-01-17

Participant Flow

35 subjects were randomized

No significant events. Please see Lenze et al, Int J of Geriatric Psychiatry 2012 article for details.

Participant milestones

Measure	Memantine (1) Memantine for 12 weeks Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.	Placebo (2) Placebo for 12 weeks Placebo: Placebo distribution is planned to mimic the active drug.
Overall Study STARTED	17	18
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults

Baseline characteristics by cohort

Measure	Memantine (1) n=17 Participants Memantine for 12 weeks Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.	Placebo (2) n=18 Participants Placebo for 12 weeks Placebo: Placebo distribution is planned to mimic the active drug.	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Age, Continuous	80.1 years STANDARD_DEVIATION 9.7 • n=5 Participants	78 years STANDARD_DEVIATION 9.2 • n=7 Participants	79.1 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	18 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: week 0, week 12

Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)

Outcome measures

Measure	Memantine (1) n=17 Participants Memantine for 12 weeks Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.	Placebo (2) n=18 Participants Placebo for 12 weeks Placebo: Placebo distribution is planned to mimic the active drug.
Depressive Symptoms Week 0	12.5 units on a scale Standard Deviation 3.6	13.4 units on a scale Standard Deviation 3.7
Depressive Symptoms Week 12	7 units on a scale Standard Deviation 1.5	5.2 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: week 12

cumulative incidence over 12 weeks of follow-up

Outcome measures

Measure	Memantine (1) n=17 Participants Memantine for 12 weeks Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.	Placebo (2) n=18 Participants Placebo for 12 weeks Placebo: Placebo distribution is planned to mimic the active drug.
Incidence of Major Depressive Disorder	3 Participants	1 Participants

SECONDARY outcome

Timeframe: week 0, week 12

Population: intent to treat analysis; data presented are the week 12 data from the mixed effect model

Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)

Outcome measures

Measure	Memantine (1) n=17 Participants Memantine for 12 weeks Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.	Placebo (2) n=18 Participants Placebo for 12 weeks Placebo: Placebo distribution is planned to mimic the active drug.
Functional Recovery	73 units on a scale Standard Error 7	81 units on a scale Standard Error 6

Adverse Events

Memantine (1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (2)

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

Eric Lenze

Washington University School of Medicine

Phone: 314-362-1671

Email: lenzee@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60