Trial Outcomes & Findings for Aging Brain Changes, Executive Dysfunction and Depression (NCT NCT00918684)
NCT ID: NCT00918684
Last Updated: 2017-05-12
Results Overview
A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
116 participants
Primary outcome timeframe
14 weeks (12th week of treatment)
Results posted on
2017-05-12
Participant Flow
Participant Flow of the Overall Study
116 participants were consented and enrolled. 10 of these subjects did not participate in the washout/placebo phase.
Participant milestones
| Measure |
Escitalopram
12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily
|
|---|---|
|
Two Week Drug Washout and Placebo Phase
STARTED
|
106
|
|
Two Week Drug Washout and Placebo Phase
COMPLETED
|
90
|
|
Two Week Drug Washout and Placebo Phase
NOT COMPLETED
|
16
|
|
Treatment Phase
STARTED
|
90
|
|
Treatment Phase
COMPLETED
|
65
|
|
Treatment Phase
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Escitalopram
12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily
|
|---|---|
|
Two Week Drug Washout and Placebo Phase
Placebo Reponder
|
16
|
|
Treatment Phase
Lack of Efficacy
|
6
|
|
Treatment Phase
Lost to Follow-up
|
2
|
|
Treatment Phase
Physician Decision
|
8
|
|
Treatment Phase
Protocol Violation
|
1
|
|
Treatment Phase
Withdrawal by Subject
|
8
|
Baseline Characteristics
Aging Brain Changes, Executive Dysfunction and Depression
Baseline characteristics by cohort
| Measure |
Escitalopram
n=90 Participants
12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=5 Participants
|
|
Age, Continuous
|
70.82 Years
STANDARD_DEVIATION 6.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
90 Participants
n=5 Participants
|
|
Hamilton Scale for Depression
|
21.21 units on a scale
STANDARD_DEVIATION 4.51 • n=5 Participants
|
|
Mini Mental Status Examination (MMSE)
|
28.08 units on a scale
STANDARD_DEVIATION 1.64 • n=5 Participants
|
|
WHODAS-II Disability Score
|
34.64 units on a scale
STANDARD_DEVIATION 10.56 • n=5 Participants
|
|
Stroop Color-Word Test
|
32.77 units on a scale
STANDARD_DEVIATION 10.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeks (12th week of treatment)A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Outcome measures
| Measure |
Escitalopram
n=90 Participants
12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily
|
|---|---|
|
Hamilton Depression Rating Scale.
|
8.09 units on a scale
Standard Deviation 5.93
|
PRIMARY outcome
Timeframe: 14 weeks (12th week of treatment)A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales.
Outcome measures
| Measure |
Escitalopram
n=90 Participants
12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily
|
|---|---|
|
WHODAS-II Disability Scale
|
31.43 units on a scale
Standard Deviation 9.14
|
PRIMARY outcome
Timeframe: 14 weeks (12th week of treatment)A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales.
Outcome measures
| Measure |
Escitalopram
n=90 Participants
12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily
|
|---|---|
|
Stroop Color-Word Test
|
33.63 units on a scale
Standard Deviation 10.2
|
Adverse Events
Escitalopram
Serious events: 6 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Escitalopram
n=90 participants at risk
12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily
|
|---|---|
|
General disorders
Non-cardiac chest pain
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Psychiatric disorders
Depression
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
1.1%
1/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Psychiatric disorders
Anxiety
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
Other adverse events
| Measure |
Escitalopram
n=90 participants at risk
12-week open label with 2 week placebo period (14 weeks total)
Escitalopram: 10mg tab daily
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
2/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Psychiatric disorders
Anorgasmia
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Psychiatric disorders
Anxiety
|
5.6%
5/90 • Number of events 5 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Blood and lymphatic system disorders
Prolonged bleeding after a cut
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Eye disorders
Cataract
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
2/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
3/90 • Number of events 3 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Dizziness
|
5.6%
5/90 • Number of events 5 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Edema cerebral
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
General disorders
Edema limbs
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Injury, poisoning and procedural complications
Fall
|
12.2%
11/90 • Number of events 15 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.2%
2/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Prolonged gum bleeding
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Headache
|
3.3%
3/90 • Number of events 3 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Hydrocephalus
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Vascular disorders
Hypertension
|
6.7%
6/90 • Number of events 6 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.2%
2/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Vascular disorders
Hyponatremia
|
2.2%
2/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
2/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
2/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Infections and infestations
Papulopustular rash
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
2/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Psychiatric disorders
Homicidal ideation
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.4%
4/90 • Number of events 4 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Cardiac disorders
Sinus bradycardia
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Stroke
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Psychiatric disorders
Suicidal ideation
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Nervous system disorders
Tremor
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Infections and infestations
Upper respiratory infection
|
4.4%
4/90 • Number of events 4 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Infections and infestations
Urinary tract infection
|
4.4%
4/90 • Number of events 4 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Reproductive system and breast disorders
Vaginal infection
|
1.1%
1/90 • Number of events 1 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Cardiac disorders
Ventricular arrhythmia
|
2.2%
2/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
2/90 • Number of events 2 • Up to 14 weeks
Clinicaltrials.gov definitions apply.
|
Additional Information
Dr. George Alexopoulos, M.D.
Weill Cornell Medical College
Phone: 914-997-5767
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place