Trial Outcomes & Findings for Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer (NCT NCT00387348)

Results Overview

Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

24 participants

Primary outcome timeframe

4 weeks

Results posted on

2012-12-03

Participant Flow

Participants were recruited from the ambulatory thoracic and GI cancer clinics at MGH. Recruitment was open from 11/1/06 until 4/1/11.

After enrollment, participants completed an assessment for major depressive disorder. 90 participants consented for study evaluation. In order to be randomized to a group, participants had to meet criteria for major depressive disorder. Of the 90 evaluated on study, only 24 were randomized.

Participant milestones

Participant milestones
Measure	Placebo-Placebo Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks.	Placebo-Escitalopram Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks	Escitalopram-Placebo Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
Overall Study STARTED	8	5	11
Overall Study COMPLETED	5	2	7
Overall Study NOT COMPLETED	3	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo-Placebo Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks.	Placebo-Escitalopram Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks	Escitalopram-Placebo Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
Overall Study Death	1	1	0
Overall Study Physician Decision	1	0	1
Overall Study Withdrawal by Subject	0	2	2
Overall Study Adverse Event	1	0	1

Baseline Characteristics

Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo-Placebo n=8 Participants Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks	Placebo-Escitalopram n=5 Participants Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks	Escitalopram-Placebo n=11 Participants Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks	Total n=24 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Age Continuous	56.63 years STANDARD_DEVIATION 10.51 • n=5 Participants	59.40 years STANDARD_DEVIATION 10.84 • n=7 Participants	58.36 years STANDARD_DEVIATION 9.41 • n=5 Participants	58.00 years STANDARD_DEVIATION 9.68 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants	24 participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: The efficacy analysis was intent to treat and all randomized participants were analyzed

Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=8 Participants Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo oncedaily by mouth for the second 4 weeks	Placebo-Escitalopram n=5 Participants Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks	Escitalopram-Placebo n=11 Participants Participants in this arm were randomzied to receive escitalopram f10 mg once daily by mouth or the first 4 weeks and placebo once daily by mouth for the second 4 weeks
Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder	3 number of participants with response 0.52	1 number of participants with response 0.47	6 number of participants with response 0.52

PRIMARY outcome

Timeframe: 4 weeks

Population: Participants who had at least 1 follow up HAM-D assessment were included. Two participants died, one without a follow up assessment and one with a HAM-D at 2 weeks. For the participant who had the HAM-D at 2 weeks and then died, the last endpoint was carried forward.

The change in HAM-D scores was calculated by subtracting the score at 4 weeks from the score at baseline. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=7 Participants Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo oncedaily by mouth for the second 4 weeks	Placebo-Escitalopram n=5 Participants Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks	Escitalopram-Placebo n=11 Participants Participants in this arm were randomzied to receive escitalopram f10 mg once daily by mouth or the first 4 weeks and placebo once daily by mouth for the second 4 weeks
Change in Hamilton Depression Rating Scale (HAM-D) Scores	6.23 Change in HAM-D scores Standard Deviation 8.37	10.60 Change in HAM-D scores Standard Deviation 5.18	6.45 Change in HAM-D scores Standard Deviation 5.18

SECONDARY outcome

Timeframe: 4 weeks

Population: Participants who completed the 4 week assessment were analyzed

Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144.

Outcome measures

Outcome measures
Measure	Placebo-Placebo n=6 Participants Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo oncedaily by mouth for the second 4 weeks	Placebo-Escitalopram n=2 Participants Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks	Escitalopram-Placebo n=9 Participants Participants in this arm were randomzied to receive escitalopram f10 mg once daily by mouth or the first 4 weeks and placebo once daily by mouth for the second 4 weeks
Side Effect Burden	3.00 units on a scale Standard Deviation 2.10	2.50 units on a scale Standard Deviation 0.71	3.44 units on a scale Standard Deviation 1.88

Adverse Events

Placebo-Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo-Escitalopram

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Escitalopram-Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo-Placebo n=8 participants at risk Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks	Placebo-Escitalopram n=5 participants at risk Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks	Escitalopram-Placebo n=11 participants at risk Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) death	12.5% 1/8 • Number of events 1	20.0% 1/5 • Number of events 1	0.00% 0/11

Other adverse events

Other adverse events
Measure	Placebo-Placebo n=8 participants at risk Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks	Placebo-Escitalopram n=5 participants at risk Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks	Escitalopram-Placebo n=11 participants at risk Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
Psychiatric disorders HAM-D score increased by at least 25%	12.5% 1/8 • Number of events 1	0.00% 0/5	9.1% 1/11 • Number of events 1

Additional Information

William F Pirl, MD

Massachusetts General Hospital

Phone: 617-724-9151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place