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

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ClinicalTrials.gov Identifier: NCT00183729
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : December 15, 2016
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eric Lenze, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Memantine
Other: Placebo
Enrollment 35

Recruitment Details 35 subjects were randomized
Pre-assignment Details No significant events. Please see Lenze et al, Int J of Geriatric Psychiatry 2012 article for details.
Arm/Group Title Memantine (1) Placebo (2)
Hide Arm/Group Description

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 for 12 weeks

Placebo: Placebo distribution is planned to mimic the active drug.

Period Title: Overall Study
Started 17 18
Completed 14 13
Not Completed 3 5
Arm/Group Title Memantine (1) Placebo (2) Total
Hide Arm/Group Description

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 for 12 weeks

Placebo: Placebo distribution is planned to mimic the active drug.

Total of all reporting groups
Overall Number of Baseline Participants 17 18 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
17
 100.0%
18
 100.0%
35
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 18 participants 35 participants
80.1  (9.7) 78  (9.2) 79.1  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 18 participants 35 participants
Female
14
  82.4%
14
  77.8%
28
  80.0%
Male
3
  17.6%
4
  22.2%
7
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 18 participants 35 participants
17 18 35
1.Primary Outcome
Title Depressive Symptoms
Hide Description Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)
Time Frame week 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memantine (1) Placebo (2)
Hide Arm/Group Description:

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 for 12 weeks

Placebo: Placebo distribution is planned to mimic the active drug.

Overall Number of Participants Analyzed 17 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 12.5  (3.6) 13.4  (3.7)
Week 12 7  (1.5) 5.2  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Memantine (1), Placebo (2)
Comments Null: the two groups would not differ in depressive symptoms over time (ie both groups would improve equally in terms of their depressive symptoms) Power calculation: none; this was a pilot study
Type of Statistical Test Superiority
Comments (none)
Statistical Test of Hypothesis P-Value 0.42
Comments (none)
Method Mixed Models Analysis
Comments (none)
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2
Estimation Comments (none)
2.Secondary Outcome
Title Incidence of Major Depressive Disorder
Hide Description cumulative incidence over 12 weeks of follow-up
Time Frame week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Memantine (1) Placebo (2)
Hide Arm/Group Description:

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 for 12 weeks

Placebo: Placebo distribution is planned to mimic the active drug.

Overall Number of Participants Analyzed 17 18
Measure Type: Count of Participants
Unit of Measure: Participants
3
  17.6%
1
   5.6%
3.Secondary Outcome
Title Functional Recovery
Hide Description Functional Independence Msure, 13-item motor subscale (scale ranges 13-91, higher scores = better function)
Time Frame week 0, week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
intent to treat analysis; data presented are the week 12 data from the mixed effect model
Arm/Group Title Memantine (1) Placebo (2)
Hide Arm/Group Description:

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 for 12 weeks

Placebo: Placebo distribution is planned to mimic the active drug.

Overall Number of Participants Analyzed 17 18
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
73  (7) 81  (6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Memantine (1), Placebo (2)
Comments Null hypothesis: functional recovery would be the same in both groups. Power calculation: none. This was a pilot study.
Type of Statistical Test Superiority
Comments (no comments)
Statistical Test of Hypothesis P-Value 0.06
Comments (none)
Method Mixed Models Analysis
Comments (none)
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Memantine (1) Placebo (2)
Hide Arm/Group Description

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 for 12 weeks

Placebo: Placebo distribution is planned to mimic the active drug.

All-Cause Mortality
Memantine (1) Placebo (2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Memantine (1) Placebo (2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Memantine (1) Placebo (2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/18 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Name/Title: Eric Lenze
Organization: Washington University School of Medicine
Phone: 314-362-1671
Responsible Party: Eric Lenze, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00183729     History of Changes
Other Study ID Numbers: K23MH064196-02 ( U.S. NIH Grant/Contract )
K23MH064196-02 ( U.S. NIH Grant/Contract )
First Submitted: September 14, 2005
First Posted: September 16, 2005
Results First Submitted: July 1, 2016
Results First Posted: December 15, 2016
Last Update Posted: January 17, 2018