Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brain Aging and Treatment Response in Geriatric Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01902004
Recruitment Status : Completed
First Posted : July 17, 2013
Results First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Helen Lavretsky, MD, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Mild Cognitive Impairment (MCI)
Depression
Interventions Drug: Escitalopram
Drug: Memantine
Drug: Placebo
Enrollment 115
Recruitment Details  
Pre-assignment Details A total of 20 participants were excluded after being consented and prior to randomization. 5 were determined to be ineligible after completing the in-person screen visit in which they were consented. 15 withdrew consent before being randomized.
Arm/Group Title Escitalopram and Memantine Escitalopram and Placebo
Hide Arm/Group Description

Participants will take a combination of Escitalopram and Memantine for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day.

Participants will take a combination of Escitalopram and placebo for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day.

Period Title: Overall Study
Started 48 47
Completed 33 29
Not Completed 15 18
Arm/Group Title Escitalopram and Memantine Escitalopram and Placebo Total
Hide Arm/Group Description

Participants will take a combination of Escitalopram and Memantine for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day.

Participants will take a combination of Escitalopram and placebo for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day.

Total of all reporting groups
Overall Number of Baseline Participants 48 47 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 47 participants 95 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  29.2%
8
  17.0%
22
  23.2%
>=65 years
34
  70.8%
39
  83.0%
73
  76.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 47 participants 95 participants
71  (6.9) 72.8  (6.8) 71.9  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 47 participants 95 participants
Female
26
  54.2%
25
  53.2%
51
  53.7%
Male
22
  45.8%
22
  46.8%
44
  46.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 47 participants 95 participants
Caucasian
37
  77.1%
33
  70.2%
70
  73.7%
African American
4
   8.3%
2
   4.3%
6
   6.3%
Hispanic
3
   6.3%
8
  17.0%
11
  11.6%
Other
4
   8.3%
2
   4.3%
6
   6.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants 47 participants 95 participants
48 47 95
Hamilton Depression Rating Scale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 48 participants 47 participants 95 participants
17.8  (2.3) 17.7  (2.4) 17.8  (2.3)
[1]
Measure Description: Clinician administered scale measures severity of depressive symptoms. This measure includes 24 items. Response options vary item to item and include the following ranges: [0-2], [0-3], and [0-4]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range [0-74], higher scores representing more severe difficulties.
1.Primary Outcome
Title Change in Hamilton Depression Rating Scale
Hide Description Clinician administered scale measures severity of depressive symptoms. This measure includes 24 items. Response options vary item to item and include the following ranges: [0-2], [0-3], and [0-4]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range [0-74], higher scores representing more severe difficulties.
Time Frame Measured at 3 months; 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants with available data at each time point differs due to participant dropout over the course of the study.
Arm/Group Title Escitalopram and Memantine Escitalopram and Placebo
Hide Arm/Group Description:

Participants will take a combination of Escitalopram and Memantine for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day.

Participants will take a combination of Escitalopram and placebo for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day.

Overall Number of Participants Analyzed 48 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 48 participants 47 participants
17.8  (2.3) 17.7  (2.4)
3 Months Number Analyzed 35 participants 32 participants
6.0  (4.5) 6.7  (4.7)
6 Months Number Analyzed 33 participants 29 participants
5.9  (5.2) 6.9  (5.1)
12 Months Number Analyzed 23 participants 21 participants
7.2  (5.8) 5.4  (5.3)
2.Secondary Outcome
Title Change in Montgomery Asberg Depression Rating Scale
Hide Description Clinician administered item scale measures severity of depressive symptoms. The 10 items are measured on a 7-point scale ranging from 0 to 6; creating a total range of 0-60. A score of 0 suggests absence of symptoms and higher scores represent greater severity of depression.Severity gradations for the MADRS have been proposed (9-17 = mild, 18-34 = moderate, and ≥ 35 = severe). Treatment remission is defined as an endpoint total score ≤ 10.
Time Frame Measured at 3 months; 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants with available data at each time point differs due to participant dropout over the course of the study.
Arm/Group Title Escitalopram and Memantine Escitalopram and Placebo
Hide Arm/Group Description:

Participants will take a combination of Escitalopram and Memantine for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day.

Participants will take a combination of Escitalopram and placebo for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day.

Overall Number of Participants Analyzed 48 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 48 participants 47 participants
16.7  (3.2) 14.8  (3.5)
3 Months Number Analyzed 35 participants 32 participants
7.1  (5.9) 8.7  (5.5)
6 Months Number Analyzed 33 participants 29 participants
6.0  (5.5) 8.6  (4.5)
12 Months Number Analyzed 23 participants 21 participants
8.8  (7.3) 8.0  (6.5)
3.Secondary Outcome
Title Change in Cognitive Domain Scores
Hide Description Neuropsychological battery of tests which included the following domains: learning, delayed recall, and executive functioning. Raw scores were transformed to z-scores for each test score of interest for each participant, and then averaged. These z-scores were averaged within each neuropsychological domain to produce composite scores and then averaged over all tests to calculate a global performance score. Higher scores are indicative of better performance.
Time Frame Measured at 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants with available data at each time point differs due to participant dropout over the course of the study.
Arm/Group Title Escitalopram and Memantine Escitalopram and Placebo
Hide Arm/Group Description:

Participants will take a combination of Escitalopram and Memantine for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day.

Participants will take a combination of Escitalopram and placebo for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day.

Overall Number of Participants Analyzed 48 47
Mean (Standard Deviation)
Unit of Measure: z score
Baseline Number Analyzed 48 participants 47 participants
.02  (.62) -.04  (0.7)
6 Months Number Analyzed 33 participants 29 participants
0.03  (.53) -.1  (.67)
12 Months Number Analyzed 23 participants 21 participants
.15  (.67) -.26  (.71)
4.Other Pre-specified Outcome
Title Number of Participants With Adverse Events
Hide Description The UKU (Udvalg for Kliniske Undersogelser) Side Effect Rating Scale organizes symptoms into 4 categories (i.e., Psychic, Neurologic, Autonomic, Other) containing 8-19 symptoms each. Each symptom receives a score for degree and causal relationship. Degree is scored between 0-3 with higher scores being more severe. Causal relationship is scored as improbable, possible, or probable.
Time Frame Measured at 3, 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants with available data at each time point differs due to participant dropout over the course of the study.
Arm/Group Title Escitalopram and Memantine Escitalopram and Placebo
Hide Arm/Group Description:

Participants will take a combination of Escitalopram and Memantine for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day.

Participants will take a combination of Escitalopram and placebo for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day.

Overall Number of Participants Analyzed 48 47
Measure Type: Count of Participants
Unit of Measure: Participants
3 Months Number Analyzed 35 participants 32 participants
3
   8.6%
2
   6.3%
6 Months Number Analyzed 33 participants 29 participants
3
   9.1%
5
  17.2%
12 Months Number Analyzed 23 participants 21 participants
1
   4.3%
0
   0.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram and Memantine Escitalopram and Placebo
Hide Arm/Group Description

Participants will take a combination of Escitalopram and Memantine for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Memantine: Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day.

Participants will take a combination of Escitalopram and placebo for 12 months

Escitalopram: All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.

Placebo: Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day.

All-Cause Mortality
Escitalopram and Memantine Escitalopram and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/47 (0.00%) 
Hide Serious Adverse Events
Escitalopram and Memantine Escitalopram and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/47 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Escitalopram and Memantine Escitalopram and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   41/48 (85.42%)   41/47 (87.23%) 
Cardiac disorders     
Palpitations/Tachycardia *  0/48 (0.00%)  1/47 (2.13%) 
Eye disorders     
Accomodation Disturbance *  1/48 (2.08%)  0/47 (0.00%) 
Gastrointestinal disorders     
Nausea/Vomiting *  2/48 (4.17%)  5/47 (10.64%) 
Diarrhea *  1/48 (2.08%)  1/47 (2.13%) 
Constipation *  3/48 (6.25%)  4/47 (8.51%) 
General disorders     
Increased Salivation *  0/48 (0.00%)  1/47 (2.13%) 
Reduced Salivation *  4/48 (8.33%)  7/47 (14.89%) 
Orthostatic Dizziness *  3/48 (6.25%)  4/47 (8.51%) 
Increased Tendancy to Sweating *  1/48 (2.08%)  0/47 (0.00%) 
Metabolism and nutrition disorders     
Weight Gain *  1/48 (2.08%)  2/47 (4.26%) 
Nervous system disorders     
Failing Memory *  2/48 (4.17%)  2/47 (4.26%) 
Headache *  5/48 (10.42%)  2/47 (4.26%) 
Psychiatric disorders     
Concentration Difficulties *  4/48 (8.33%)  5/47 (10.64%) 
Asthenia/Lassitude/Increased Fatigability *  3/48 (6.25%)  2/47 (4.26%) 
Sleepiness/Sedation *  11/48 (22.92%)  11/47 (23.40%) 
Depression *  0/48 (0.00%)  1/47 (2.13%) 
Tension/Inner Unrest *  4/48 (8.33%)  3/47 (6.38%) 
Increased Duration of Sleep *  1/48 (2.08%)  3/47 (6.38%) 
Reduced Duration of Sleep *  1/48 (2.08%)  3/47 (6.38%) 
Increased Dream Activity *  1/48 (2.08%)  1/47 (2.13%) 
Renal and urinary disorders     
Micturtion Disturbances *  1/48 (2.08%)  3/47 (6.38%) 
Polyuria/Polydipsia *  3/48 (6.25%)  3/47 (6.38%) 
Reproductive system and breast disorders     
Diminished Sexual Drive *  4/48 (8.33%)  4/47 (8.51%) 
Erectile Dysfunction *  2/48 (4.17%)  2/47 (4.26%) 
Ejaculatory Dysfunction *  1/48 (2.08%)  1/47 (2.13%) 
Orgastic Dysfunction *  0/48 (0.00%)  1/47 (2.13%) 
Skin and subcutaneous tissue disorders     
Rash *  0/48 (0.00%)  2/47 (4.26%) 
Pruritus *  0/48 (0.00%)  2/47 (4.26%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Dr. Helen Lavretsky
Organization: UCLA Semel Institute for Neuroscience and Human Behavior
Phone: (310)794-4619
EMail: hlavretsky@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Helen Lavretsky, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01902004    
Other Study ID Numbers: R-01 MH097892
R01MH097892 ( U.S. NIH Grant/Contract )
First Submitted: May 31, 2013
First Posted: July 17, 2013
Results First Submitted: August 7, 2019
Results First Posted: October 15, 2019
Last Update Posted: October 15, 2019