Trial Outcomes & Findings for Treatment Response of Geriatric Depression (NCT NCT00754936)
NCT ID: NCT00754936
Last Updated: 2019-03-19
Results Overview
A published and widely used scale for measuring severity of depression. Montgomery Asberg Depression Rating Scale scores can range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
14 weeks from enrollment (12 weeks from medication start)
Results posted on
2019-03-19
Participant Flow
Overall flow of study participants
106 participants enrolled in the study; however, 35 exited during the 2-week washout period and did not start study medication.
Participant milestones
| Measure |
Escitalopram
12 week open label with 2 week placebo period (14 weeks total)
Escitalopram: 20 mg by mouth daily
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Escitalopram
12 week open label with 2 week placebo period (14 weeks total)
Escitalopram: 20 mg by mouth daily
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Side Effects
|
3
|
|
Overall Study
Inter-current medical events
|
3
|
Baseline Characteristics
Treatment Response of Geriatric Depression
Baseline characteristics by cohort
| Measure |
Escitalopram
n=71 Participants
12 week open label with 2 week placebo period (14 weeks total)
Escitalopram: 20 mg by mouth daily
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
58 Participants
n=99 Participants
|
|
Age, Continuous
|
71.91 years
STANDARD_DEVIATION 7.53 • n=99 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=99 Participants
|
|
Hamilton Depression Rating Scale (HDRS) 24-Item Total Score
|
23.83 units on a scale
STANDARD_DEVIATION 4.48 • n=99 Participants
|
|
Montgomery and Asberg Depression Rating Scale (MADRS) Total Score
|
24.08 units on a scale
STANDARD_DEVIATION 5.74 • n=99 Participants
|
PRIMARY outcome
Timeframe: 14 weeks from enrollment (12 weeks from medication start)A published and widely used scale for measuring severity of depression. Montgomery Asberg Depression Rating Scale scores can range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.
Outcome measures
| Measure |
Escitalopram
n=71 Participants
12 week open label with 2 week placebo period (14 weeks total)
Escitalopram: 20 mg by mouth daily
|
|---|---|
|
Montgomery Asberg Depression Rating Scale (Depression Severity)
|
12.23 units on a scale
Standard Deviation 7.67
|
SECONDARY outcome
Timeframe: 14 weeks from enrollment (12 weeks from medication start)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=71 Participants
12 week open label with 2 week placebo period (14 weeks total)
Escitalopram: 20 mg by mouth daily
|
|---|---|
|
Hamilton Depression Rating Scale (Depression Severity)
|
11.47 units on a scale
Standard Deviation 6.64
|
Adverse Events
Escitalopram
Serious events: 3 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Escitalopram
n=71 participants at risk
12 week open label with 2 week placebo period (14 weeks total)
Escitalopram: 20 mg by mouth daily
|
|---|---|
|
Surgical and medical procedures
Hospitalisation
|
4.2%
3/71 • Number of events 3 • 14 weeks
|
Other adverse events
| Measure |
Escitalopram
n=71 participants at risk
12 week open label with 2 week placebo period (14 weeks total)
Escitalopram: 20 mg by mouth daily
|
|---|---|
|
Nervous system disorders
Sinus headache
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Nervous system disorders
Burning sensation
|
2.8%
2/71 • Number of events 3 • 14 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Investigations
Colonoscopy
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Infections and infestations
Conjunctivitis
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
16.9%
12/71 • Number of events 15 • 14 weeks
|
|
Nervous system disorders
Dizziness
|
4.2%
3/71 • Number of events 3 • 14 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
29.6%
21/71 • Number of events 38 • 14 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Infections and infestations
Groin infection
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Endocrine disorders
Hyperparathyroidism
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Renal and urinary disorders
Micturition urgency
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.8%
2/71 • Number of events 2 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
2/71 • Number of events 2 • 14 weeks
|
|
Infections and infestations
Sinusitis
|
2.8%
2/71 • Number of events 2 • 14 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Surgical and medical procedures
Surgery
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
2/71 • Number of events 2 • 14 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
|
Investigations
Weight decreased
|
1.4%
1/71 • Number of events 1 • 14 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place