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Mechanisms of Antidepressant Non-Response in Late-Life Depression

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ClinicalTrials.gov Identifier: NCT01931202
Recruitment Status : Completed
First Posted : August 29, 2013
Results First Posted : April 8, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Bret Rutherford, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Escitalopram
Drug: Placebo oral tablet
Enrollment 138
Recruitment Details  
Pre-assignment Details 138 subjects signed consent, 108 were randomized to one of the 3 arms therefore they cannot be classified to any of the below arms.
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg increased to escitalopram 20mg or placebo at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Period Title: Overall Study
Started 8 51 49
Completed 8 46 45
Not Completed 0 5 4
Reason Not Completed
Withdrawal by Subject             0             0             2
Lost to Follow-up             0             5             2
Arm/Group Title Placebo Escitalopram Open Treatment With Escitalopram Total
Hide Arm/Group Description

Blinded treatment with placebo.

Placebo oral tablet: Inert substance or treatment which is designed to have no therapeutic value but resemble the active medication in this study

Blinded treatment with either escitalopram, increased to escitalopram 20mg or placebo at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Total of all reporting groups
Overall Number of Baseline Participants 8 51 49 108
Hide Baseline Analysis Population Description
Although 138 subjects were enrolled (signed consent), only 108 were randomized and included in analysis.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age at Screening Number Analyzed 8 participants 51 participants 49 participants 108 participants
73.9  (7.2) 70.7  (8.4) 69.2  (7.2) 70.2  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 51 participants 49 participants 108 participants
Female
6
  75.0%
32
  62.7%
32
  65.3%
70
  64.8%
Male
2
  25.0%
19
  37.3%
17
  34.7%
38
  35.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 51 participants 49 participants 108 participants
Asian 0 0 1 1
Black/African American 1 6 8 15
White 5 35 34 74
More than one 1 6 3 10
Don't Know 1 3 3 7
Missing 0 1 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants 51 participants 49 participants 108 participants
8
 100.0%
51
 100.0%
49
 100.0%
108
 100.0%
Hamilton Rating Scale for Depression (HRSD)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 51 participants 49 participants 108 participants
22.8  (4.9) 23.6  (6.1) 22.9  (6.3) 23.2  (6.1)
[1]
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
1.Primary Outcome
Title Hamilton Rating Scale for Depression (HRSD)
Hide Description Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 8 51 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
22.8  (4.9) 23.6  (6.1) 22.9  (6.3)
2.Secondary Outcome
Title Hamilton Rating Scale for Depression (HRSD)
Hide Description Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Although 138 subjects were enrolled (signed consent) and 108 were randomized, only 99 completed the Hamilton Rating Scale for Depression (HRSD) at week 8.
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg , increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 8 46 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.25  (5.50) 14.39  (8.13) 11.67  (7.58)
3.Secondary Outcome
Title Quick Inventory of Depressive Symptoms (QIDS-SR)
Hide Description QIDS-SR is a 16 item scale self-report form that was used to measure depression outcomes. This self-report is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression. The scores range from 0-27 with 27 being worse depressive symptoms.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects were consented, of which 108 were randomized, however only 107 completed baseline Quick Inventory of Depressive Symptoms (QIDS-SR).
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg , increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 8 50 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.4  (4.4) 13.5  (4.5) 13.0  (4.7)
4.Secondary Outcome
Title Quick Inventory of Depressive Symptoms (QIDS-SR)
Hide Description QIDS-SR is a 16 item scale self-report form that was used to measure depression outcomes. This self-report is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression. The scores range from 0-27 with 27 being worse depressive symptoms.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects were consented, of which 108 were randomized, however only 99 completed week 8 Quick Inventory of Depressive Symptoms (QIDS-SR).
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg , increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 8 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.00  (2.93) 6.93  (5.14) 6.34  (5.31)
5.Secondary Outcome
Title Credibility and Expectancy Scale-Better (CES)
Hide Description CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. Question 2 ('Better') asks the patient the chances of their depression being completely better at the end of this study, from 1 = very poor to 7 = very good. The higher the number, the higher the expectancy that they will be better.
Time Frame Pre-Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects were consented, of which 108 were randomized, however only 101 completed pre-baseline Credibility and Expectancy Scale-Better (CES).
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 8 46 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
6  (1.1) 5.5  (1.2) 5.3  (1.3)
6.Secondary Outcome
Title Credibility and Expectancy Scale-Better (CES)
Hide Description CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. Question 2 ('Better') asks the patient the chances of their depression being completely better at the end of this study, from 1 = very poor to 7 = very good. The higher the number, the higher the expectancy that they will be better.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects were consented, of which 108 were randomized, however only 106 completed week 0 Credibility and Expectancy Scale-Better (CES).
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with either escitalopram 10mg , increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 8 50 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.63  (0.92) 5.00  (1.36) 5.67  (1.40)
7.Secondary Outcome
Title Credibility and Expectancy Scale-Depression
Hide Description CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. CES question 3 ('Depression') asks how the patient's depression will be at the end of the study, compared with now, from 1 = much worse to 7= much better. The higher the number, the higher the expectancy that their depression will be much better.
Time Frame Pre-baseline
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects were consented, of which 108 were randomized, however only 101 completed pre-baseline Credibility and Expectancy Scale-Depression.
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with either escitalopram 10mg , increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 8 46 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.3  (1.2) 6.0  (0.9) 5.9  (0.9)
8.Secondary Outcome
Title Credibility and Expectancy Scale-Depression
Hide Description CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. CES question 3 ('Depression') asks how the patient's depression will be at the end of the study, compared with now, from 1 = much worse to 7= much better. The higher the number, the higher the expectancy that their depression will be much better.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects were consented, of which 108 were randomized, however only 106 completed week 0 Credibility and Expectancy Scale-Depression.
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 8 50 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.88  (0.99) 5.40  (1.09) 6.06  (0.84)
9.Secondary Outcome
Title Quick Inventory of Depression Scale (QIDS-SR): Expectancy
Hide Description This 16-items assessment is used to rate the 9 criterion symptom domains of a major depressive episode: 4 items are used to rate sleep disturbance (early, middle, and late insomnia plus hypersomnia); 2 items are used to rate psychomotor disturbance (agitation and retardation); 4 items are used to rate appetite/weight disturbance (appetite increase or decrease and weight increase or decrease). Only 1 item is used to rate the remaining 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, and suicidal ideation). Each item is rated 0-3. For symptom domains that require more than 1 item, the highest score of the item relevant for each domain is taken. The total score ranges from 0-27. A lower rating indicates higher expectancy of improvement and lower expectation of depressive symptomatology, and a higher rating indicates lower expectancy of improvement, higher expectation of depression.
Time Frame Pre-Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects were consented, of which 108 were randomized, however only 101 completed pre-baseline Quick Inventory of Depression Scale (QIDS-SR): Expectancy.
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 8 46 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.3  (6.2) 4.8  (3.7) 5.8  (4.5)
10.Secondary Outcome
Title Quick Inventory of Depression Scale (QIDS-SR): Expectancy
Hide Description This 16-items assessment is used to rate the 9 criterion symptom domains of a major depressive episode: 4 items are used to rate sleep disturbance (early, middle, and late insomnia plus hypersomnia); 2 items are used to rate psychomotor disturbance (agitation and retardation); 4 items are used to rate appetite/weight disturbance (appetite increase or decrease and weight increase or decrease). Only 1 item is used to rate the remaining 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, and suicidal ideation). Each item is rated 0-3. For symptom domains that require more than 1 item, the highest score of the item relevant for each domain is taken. The total score ranges from 0-27. A lower rating indicates higher expectancy of improvement and lower expectation of depressive symptomatology, and a higher rating indicates lower expectancy of improvement, higher expectation of depression.
Time Frame Week 0
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects were consented, of which 108 were randomized, however only 107 completed week 0 Quick Inventory of Depression Scale (QIDS-SR): Expectancy.
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 8 50 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.63  (3.42) 6.20  (4.83) 4.92  (3.83)
11.Secondary Outcome
Title Executive Dysfunction: Stroop Color Word
Hide Description Stroop Color Word test asks patients to name the color of a word rather than reading the word. Stroop Color Word is how many colors they can name in 45 sec (higher is better, e.g., less executive dysfunction).
Time Frame Pre-Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects were consented, of which 108 were randomized, however only 106 completed pre-baseline Executive Dysfunction: Stroop Color Word.
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 7 50 49
Mean (Standard Deviation)
Unit of Measure: correct items
31.7  (6.1) 31.0  (9.0) 32.6  (11.0)
12.Secondary Outcome
Title Executive Dysfunction: Stroop Interference
Hide Description The Stroop is a measure of inhibition under distracting conditions that is sensitive to frontal lobe dysfunction. in Stroop Color Word test patients are to name the color of a word rather than reading the word. Stroop Color Word is how many colors they can name in 45 sec (higher is better, e.g., less executive dysfunction). Stroop Interference is this score adjusted for age and education.
Time Frame Pre-Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects were consented, of which 108 were randomized, however only 105 completed pre-baseline Executive Dysfunction: Stroop Interference.
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 6 50 49
Mean (Standard Deviation)
Unit of Measure: correct items
42.2  (6.8) 42.9  (11.2) 44.1  (10.4)
13.Secondary Outcome
Title White Matter Hyperintensity (WMH) Outcome- Total WMH
Hide Description Magnetic Resonance Imaging (MRI) of the Brain was acquired. We rated the severity of WMH on axial T2 FLAIR images using the Fazekas modified Coffey Rating Scale. Deep WMH are scored as 0 (absent), 1 (punctate foci), 2 (beginning confluence of foci), and 3 (large confluent areas); subcortical gray matter HIs (basal ganglia) are scored as 0 (absent), 1 (punctate), 2 (multipunctate), and 3 (diffuse); periventricular HIs are scored as 0 (absent), 1 (caps), 2 (smooth halo), and 3 (irregular and extending into the deep white matter). Our primary measure of WMH burden will be DWMH score, which has been used to establish the only empirically validated diagnostic criteria for vascular depression, where scores of 0-1 were normal, but 2-3 indicated WHM.
Time Frame Pre-Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
138 subjects signed consent and 108 were randomized, however not all participants underwent MRI scanning.
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description:
Blinded treatment with placebo, one pill a day. If after the 4 weeks, the patient has not remitted, they will be increased to 2 pills a day.

Blinded treatment with either escitalopram 10mg o increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Overall Number of Participants Analyzed 5 28 33
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.3  (1.7) 2.1  (1.9) 1.9  (2.2)
Time Frame Adverse events were collected through the 8 week period of the study.
Adverse Event Reporting Description Adverse events were collected during weekly visit with the patients.
 
Arm/Group Title Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Hide Arm/Group Description Blinded treatment with placebo, 1 pill a day for 4 weeks. At week 4, if patients have not remitted, they were increased to 2 pills a day.

Blinded treatment with either escitalopram 10mg, increased to escitalopram 20mg at week 4 if depression has not remitted

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

Open treatment with 10mg of escitalopram, increased to 20mg if depression has not remitted at week 4.

Escitalopram: Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.

All-Cause Mortality
Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/51 (0.00%)      0/49 (0.00%)    
Hide Serious Adverse Events
Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      2/51 (3.92%)      1/49 (2.04%)    
Nervous system disorders       
Fall *  0/8 (0.00%)  0 2/51 (3.92%)  2 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chest Pain *  0/8 (0.00%)  0 0/51 (0.00%)  0 1/49 (2.04%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Double Blind-Placebo Group Double Blind-Escitalopram Group Open Treatment With Escitalopram
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/51 (0.00%)      0/49 (0.00%)    
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: Bret R. Rutherford
Organization: New York State Psychiatric Institute
Phone: 6467748660
EMail: bret.rutherford@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Bret Rutherford, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01931202    
Other Study ID Numbers: 6836
First Submitted: August 26, 2013
First Posted: August 29, 2013
Results First Submitted: March 7, 2020
Results First Posted: April 8, 2020
Last Update Posted: July 2, 2020