Trial Outcomes & Findings for Developing New Clinical Management Strategies (NCT NCT02082392)

Results Overview

scale for depressive symptoms administered by trained rater. The HRSD is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the HRSD list 21 items, the scoring is based on the first 17 items. sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \>=23 = Very Severe Depression

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

Baseline week

Results posted on

2020-03-03

Participant Flow

Recruitment will be coordinated through the Adult and Late Life Depression Research Clinic and will include flyers posted around Columbia University Medical Center (CUMC), information posted on the CUMC internet website, advertisements in local newspapers and on radio stations, and outreach to CUMC clinical staff.

Interested individuals will contact the ALLDRC coordinator, a telephone screening will take place to identify obviously ineligible subjects. Potentially eligible subjects will be scheduled for an evaluation in the ALLDRC, including a clinical interview by a study clinician (psychiatrist or psychologist) and diagnostic rating by trained rater.

Participant milestones

Participant milestones
Measure	Clinical Frequency Management Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. Escitalopram	Research Frequency Management Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. Escitalopram
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Developing New Clinical Management Strategies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinical Frequency Management n=2 Participants Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. Escitalopram	Research Frequency Management n=1 Participants Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. Escitalopram	Total n=3 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 11.3 • n=5 Participants	48 years STANDARD_DEVIATION 0 • n=7 Participants	46.67 years STANDARD_DEVIATION 8.08 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline week

scale for depressive symptoms administered by trained rater. The HRSD is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the HRSD list 21 items, the scoring is based on the first 17 items. sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \>=23 = Very Severe Depression

Outcome measures

Outcome measures
Measure	Clinical Frequency Management n=2 Participants Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. Escitalopram	Research Frequency Management n=1 Participants Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. Escitalopram
Hamilton Rating Scale for Depression	25 units on a scale Standard Deviation 4.24	31 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline week

Scale for anxiety symptoms administered by trained rater. The HARS is a standard measure of anxiety severity in pharmacotherapy studies that has been shown to have acceptable reliability and validity in studies of depressed patients. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where \<17 indi-cates mild severity, 18-24 mild to moderate severity and25-30 moderate to severe.

Outcome measures

Outcome measures
Measure	Clinical Frequency Management n=2 Participants Study visits monthly (Week 0, 4, and 8), with phone visits every other week (Week 2 and 6). Double-blind, placebo-controlled treatment with escitalopram 10mg/day, raised to 20mg/day, if non-responders at week 4. Escitalopram	Research Frequency Management n=1 Participants Weekly study visits, treatment with double-blind, placebo controlled escitalopram 10 mg/day, raised to 20mg/day at week 4 if non-responders. Escitalopram
Hamilton Anxiety Rating Scale (HARS) 14-item Scale	9.5 units on a scale Standard Deviation 7.78	13 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline week

scales developed to measure the clinician's view of subjects' global functioning before and after initiating a study medication. The CGI correlates well with other standard outcome measures for depression (e.g., HRSD), is sensitive to change in antidepressant trials, and offers clinically understandable anchor points. 7-point scale: 0 = Not assessed 4 = Moderately ill 1 = Normal, not at all ill 5 = Markedly ill 2 = Borderline mentally ill 6 = Severely ill 3 = Mildly ill 7 = Among the most extremely ill patients