Trial Outcomes & Findings for Escitalopram (Lexapro) for Depression MS or ALS (NCT NCT00965497)

Results Overview

Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

13 participants

Primary outcome timeframe

8 weeks

Results posted on

2019-05-01

Participant Flow

Recruited through local neurology groups and ALS and MS support groups. No subjects with ALS were recruited.

Patients switched from another antidepressant to escitalopram were either cross-titrated to escitalopram over 1 week or went through 3 day washout before starting escitalopram. Subjects with uncontrolled medical conditions (i.e., uncontrolled hypertension)were excluded.

Participant milestones

Participant milestones
Measure	Open-label, Single Arm All patients will receive the intervention
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-label, Single Arm All patients will receive the intervention
Overall Study Physician Decision	1

Baseline Characteristics

Escitalopram (Lexapro) for Depression MS or ALS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label, Single Arm n=14 Participants All patients will receive the intervention
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	14 participants n=99 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Intention to Treat

Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression.

Outcome measures

Outcome measures
Measure	Escitalopram n=13 Participants One-arm study of escitalopram 20 mg daily
Hamilton Depression Scale (HAM-D 17).	15 depression severity Standard Deviation 7

SECONDARY outcome

Timeframe: 8 weeks

McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent).

Outcome measures

Outcome measures
Measure	Escitalopram n=13 Participants One-arm study of escitalopram 20 mg daily
McGill Quality of Life Scale (MQOL)	5 quality of life Interval 0.0 to 10.0

Adverse Events

Open-label, Single Arm

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open-label, Single Arm n=14 participants at risk All patients will receive the intervention
Gastrointestinal disorders Nausea vomiting and diarrhea	35.7% 5/14 • Number of events 5

Additional Information

Meera Narasimhan, MD

University of South Carolina School of Medicine

Phone: 803-434-1100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place