Trial Outcomes & Findings for Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder (NCT NCT00621946)

Results Overview

The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

Baseline

Results posted on

2014-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Escitalopram Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4.	Matching Placebo Placebo Matching Escitalopram taken orally daily (for a 12-week duration).
Overall Study STARTED	13	13
Overall Study COMPLETED	13	12
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram n=13 Participants Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.	Placebo n=12 Participants Placebo Matching Escitalopram taken orally daily.	Total n=25 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 9.8 • n=5 Participants	48.6 years STANDARD_DEVIATION 12.7 • n=7 Participants	45.4 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	12 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).

Outcome measures

Outcome measures
Measure	Escitalopram n=13 Participants Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.	Placebo n=12 Participants Placebo Matching Escitalopram taken orally daily.
HAM-D (Hamilton Rating Scale for Depression)	24.8 units on a scale Standard Deviation 4.4	28.3 units on a scale Standard Deviation 5.1

PRIMARY outcome

Timeframe: Baseline

The ACQ is a questionnaire used to assess symptoms pertinent to asthma management. Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).

Outcome measures

Outcome measures
Measure	Escitalopram n=13 Participants Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.	Placebo n=12 Participants Placebo Matching Escitalopram taken orally daily.
ACQ (Asthma Control Questionnaire)	1.9 units on a scale Standard Deviation 1.1	2.9 units on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: Baseline

The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).

Outcome measures

Outcome measures
Measure	Escitalopram n=13 Participants Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.	Placebo n=12 Participants Placebo Matching Escitalopram taken orally daily.
IDS-SR (Inventory of Depressive Symptomatology - Self-Report)	35.2 units on a scale Standard Deviation 15.0	42.9 units on a scale Standard Deviation 12.3

PRIMARY outcome

Timeframe: Up to 12 weeks

The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome).

Outcome measures

Outcome measures
Measure	Escitalopram n=13 Participants Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.	Placebo n=12 Participants Placebo Matching Escitalopram taken orally daily.
HAM-D (Hamilton Rating Scale for Depression)	16.7 units on a scale Standard Deviation 11.4	17.7 units on a scale Standard Deviation 7.6

PRIMARY outcome

Timeframe: Up to 12 weeks

The ACQ is a questionnaire used to assess symptoms pertinent to asthma management.Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items).

Outcome measures

Outcome measures
Measure	Escitalopram n=13 Participants Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.	Placebo n=12 Participants Placebo Matching Escitalopram taken orally daily.
ACQ (Asthma Control Questionnaire)	1.9 units on a scale Standard Deviation 1.4	2.4 units on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: Up to 12 weeks

The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome).

Outcome measures

Outcome measures
Measure	Escitalopram n=13 Participants Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.	Placebo n=12 Participants Placebo Matching Escitalopram taken orally daily.
IDS-SR (Inventory of Depressive Symptomatology - Self-Report)	26.3 units on a scale Standard Deviation 17.4	24.6 units on a scale Standard Deviation 14.9

Adverse Events

Escitalopram

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Escitalopram n=13 participants at risk Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.	Placebo n=12 participants at risk Placebo Matching Escitalopram taken orally daily.
Respiratory, thoracic and mediastinal disorders Severe asthma attack	7.7% 1/13 • Number of events 1	0.00% 0/12
Respiratory, thoracic and mediastinal disorders Asthma exacerbation	7.7% 1/13 • Number of events 1	0.00% 0/12
Respiratory, thoracic and mediastinal disorders Respiratory Infection	0.00% 0/13	8.3% 1/12 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

E. Sherwood Brown, MD, PhD

The University of Texas Southwestern Medical Center

Phone: 214-645-6950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place