Trial Outcomes & Findings for Brain Aging and Treatment Response in Geriatric Depression (NCT NCT01902004)
NCT ID: NCT01902004
Last Updated: 2019-10-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
115 participants
Primary outcome timeframe
Measured at 3 months; 6 months and 12 months
Results posted on
2019-10-15
Participant Flow
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.
Participant milestones
| Measure |
Escitalopram and Memantine
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.
|
Escitalopram and Placebo
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 Study
STARTED
|
48
|
47
|
|
Overall Study
COMPLETED
|
33
|
29
|
|
Overall Study
NOT COMPLETED
|
15
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Aging and Treatment Response in Geriatric Depression
Baseline characteristics by cohort
| Measure |
Escitalopram and Memantine
n=48 Participants
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.
|
Escitalopram and Placebo
n=47 Participants
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
n=95 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
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
72.8 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
71.9 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
47 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Hamilton Depression Rating Scale Score
|
17.8 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
17.7 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
17.8 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at 3 months; 6 months and 12 monthsPopulation: The number of participants with available data at each time point differs due to participant dropout over the course of the study.
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.
Outcome measures
| Measure |
Escitalopram and Memantine
n=48 Participants
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.
|
Escitalopram and Placebo
n=47 Participants
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.
|
|---|---|---|
|
Change in Hamilton Depression Rating Scale
Baseline
|
17.8 units on a scale
Standard Deviation 2.3
|
17.7 units on a scale
Standard Deviation 2.4
|
|
Change in Hamilton Depression Rating Scale
3 Months
|
6.0 units on a scale
Standard Deviation 4.5
|
6.7 units on a scale
Standard Deviation 4.7
|
|
Change in Hamilton Depression Rating Scale
6 Months
|
5.9 units on a scale
Standard Deviation 5.2
|
6.9 units on a scale
Standard Deviation 5.1
|
|
Change in Hamilton Depression Rating Scale
12 Months
|
7.2 units on a scale
Standard Deviation 5.8
|
5.4 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Measured at 3 months; 6 months and 12 monthsPopulation: The number of participants with available data at each time point differs due to participant dropout over the course of the study.
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.
Outcome measures
| Measure |
Escitalopram and Memantine
n=48 Participants
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.
|
Escitalopram and Placebo
n=47 Participants
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.
|
|---|---|---|
|
Change in Montgomery Asberg Depression Rating Scale
Baseline
|
16.7 units on a scale
Standard Deviation 3.2
|
14.8 units on a scale
Standard Deviation 3.5
|
|
Change in Montgomery Asberg Depression Rating Scale
3 Months
|
7.1 units on a scale
Standard Deviation 5.9
|
8.7 units on a scale
Standard Deviation 5.5
|
|
Change in Montgomery Asberg Depression Rating Scale
6 Months
|
6.0 units on a scale
Standard Deviation 5.5
|
8.6 units on a scale
Standard Deviation 4.5
|
|
Change in Montgomery Asberg Depression Rating Scale
12 Months
|
8.8 units on a scale
Standard Deviation 7.3
|
8.0 units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Measured at 6 months and 12 monthsPopulation: The number of participants with available data at each time point differs due to participant dropout over the course of the study.
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.
Outcome measures
| Measure |
Escitalopram and Memantine
n=48 Participants
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.
|
Escitalopram and Placebo
n=47 Participants
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.
|
|---|---|---|
|
Change in Cognitive Domain Scores
Baseline
|
.02 z score
Standard Deviation .62
|
-.04 z score
Standard Deviation 0.7
|
|
Change in Cognitive Domain Scores
6 Months
|
0.03 z score
Standard Deviation .53
|
-.1 z score
Standard Deviation .67
|
|
Change in Cognitive Domain Scores
12 Months
|
.15 z score
Standard Deviation .67
|
-.26 z score
Standard Deviation .71
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 3, 6 months and 12 monthsPopulation: The number of participants with available data at each time point differs due to participant dropout over the course of the study.
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.
Outcome measures
| Measure |
Escitalopram and Memantine
n=48 Participants
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.
|
Escitalopram and Placebo
n=47 Participants
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.
|
|---|---|---|
|
Number of Participants With Adverse Events
3 Months
|
3 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
6 Months
|
3 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events
12 Months
|
1 Participants
|
0 Participants
|
Adverse Events
Escitalopram and Memantine
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Escitalopram and Placebo
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Escitalopram and Memantine
n=48 participants at risk
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.
|
Escitalopram and Placebo
n=47 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Concentration Difficulties
|
8.3%
4/48 • 1 year
|
10.6%
5/47 • 1 year
|
|
Psychiatric disorders
Asthenia/Lassitude/Increased Fatigability
|
6.2%
3/48 • 1 year
|
4.3%
2/47 • 1 year
|
|
Psychiatric disorders
Sleepiness/Sedation
|
22.9%
11/48 • 1 year
|
23.4%
11/47 • 1 year
|
|
Nervous system disorders
Failing Memory
|
4.2%
2/48 • 1 year
|
4.3%
2/47 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/48 • 1 year
|
2.1%
1/47 • 1 year
|
|
Psychiatric disorders
Tension/Inner Unrest
|
8.3%
4/48 • 1 year
|
6.4%
3/47 • 1 year
|
|
Psychiatric disorders
Increased Duration of Sleep
|
2.1%
1/48 • 1 year
|
6.4%
3/47 • 1 year
|
|
Psychiatric disorders
Reduced Duration of Sleep
|
2.1%
1/48 • 1 year
|
6.4%
3/47 • 1 year
|
|
Psychiatric disorders
Increased Dream Activity
|
2.1%
1/48 • 1 year
|
2.1%
1/47 • 1 year
|
|
Eye disorders
Accomodation Disturbance
|
2.1%
1/48 • 1 year
|
0.00%
0/47 • 1 year
|
|
General disorders
Increased Salivation
|
0.00%
0/48 • 1 year
|
2.1%
1/47 • 1 year
|
|
General disorders
Reduced Salivation
|
8.3%
4/48 • 1 year
|
14.9%
7/47 • 1 year
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
4.2%
2/48 • 1 year
|
10.6%
5/47 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/48 • 1 year
|
2.1%
1/47 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
6.2%
3/48 • 1 year
|
8.5%
4/47 • 1 year
|
|
Renal and urinary disorders
Micturtion Disturbances
|
2.1%
1/48 • 1 year
|
6.4%
3/47 • 1 year
|
|
Renal and urinary disorders
Polyuria/Polydipsia
|
6.2%
3/48 • 1 year
|
6.4%
3/47 • 1 year
|
|
General disorders
Orthostatic Dizziness
|
6.2%
3/48 • 1 year
|
8.5%
4/47 • 1 year
|
|
Cardiac disorders
Palpitations/Tachycardia
|
0.00%
0/48 • 1 year
|
2.1%
1/47 • 1 year
|
|
General disorders
Increased Tendancy to Sweating
|
2.1%
1/48 • 1 year
|
0.00%
0/47 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/48 • 1 year
|
4.3%
2/47 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/48 • 1 year
|
4.3%
2/47 • 1 year
|
|
Metabolism and nutrition disorders
Weight Gain
|
2.1%
1/48 • 1 year
|
4.3%
2/47 • 1 year
|
|
Reproductive system and breast disorders
Diminished Sexual Drive
|
8.3%
4/48 • 1 year
|
8.5%
4/47 • 1 year
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
4.2%
2/48 • 1 year
|
4.3%
2/47 • 1 year
|
|
Reproductive system and breast disorders
Ejaculatory Dysfunction
|
2.1%
1/48 • 1 year
|
2.1%
1/47 • 1 year
|
|
Reproductive system and breast disorders
Orgastic Dysfunction
|
0.00%
0/48 • 1 year
|
2.1%
1/47 • 1 year
|
|
Nervous system disorders
Headache
|
10.4%
5/48 • 1 year
|
4.3%
2/47 • 1 year
|
Additional Information
Dr. Helen Lavretsky
UCLA Semel Institute for Neuroscience and Human Behavior
Phone: (310)794-4619
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place