Trial Outcomes & Findings for Escitalopram in Adult Patients With Major Depressive Disorder (NCT NCT00668525)

Last Updated: 2010-05-11

Results Overview

The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

877 participants

Primary outcome timeframe

Change from baseline in MADRS total score at week 8

Results posted on

2010-05-11

Participant Flow

Recruitment period was from 4/30/08 through 12/19/08 with last patient last visit on 2/24/09 at 45 centers in the US.

A one-week single-blind placebo period was completed prior to randomization. Patients were then randomized in a 3:3:2 ratio to either escitalopram low dose, escitalopram high dose or placebo.

Participant milestones

Participant milestones
Measure	Escitalopram Low Dose Escitalopram low dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Escitalopram High Dose Escitalopram high dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Placebo Placebo, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Overall Study STARTED	325	332	220
Overall Study COMPLETED	248	239	167
Overall Study NOT COMPLETED	77	93	53

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Escitalopram in Adult Patients With Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram Low Dose n=322 Participants Escitalopram low dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Escitalopram High Dose n=324 Participants Escitalopram high dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Placebo n=218 Participants Placebo, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Total n=864 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	322 Participants n=5 Participants	324 Participants n=7 Participants	218 Participants n=5 Participants	864 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	41.4 years STANDARD_DEVIATION 12.3 • n=5 Participants	40.4 years STANDARD_DEVIATION 11.9 • n=7 Participants	42.3 years STANDARD_DEVIATION 12.7 • n=5 Participants	41.3 years STANDARD_DEVIATION 12.2 • n=4 Participants
Sex: Female, Male Female	205 Participants n=5 Participants	222 Participants n=7 Participants	137 Participants n=5 Participants	564 Participants n=4 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	102 Participants n=7 Participants	81 Participants n=5 Participants	300 Participants n=4 Participants
Region of Enrollment United States	322 participants n=5 Participants	324 participants n=7 Participants	218 participants n=5 Participants	864 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline in MADRS total score at week 8

Population: The analysis was performed on the intent to treat population based on the LOCF approach using an ANCOVA model with treatment group and study center as factors and the baseline MADRS total score as a covariate.

Outcome measures

Outcome measures
Measure	Escitalopram Low Dose n=319 Participants Escitalopram low dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Escitalopram High Dose n=318 Participants Escitalopram high dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Placebo n=215 Participants Placebo, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.	-12.8 Units on a scale Standard Error 0.6 • Interval -4.6 to -1.2	-13.4 Units on a scale Standard Error 0.6 • Interval -1.9 to 1.1	-10.1 Units on a scale Standard Error 0.7 • Interval -5.0 to -1.6

SECONDARY outcome

Timeframe: Change from baseline in HAM-D at week 8

The HAMD is a clinician-rated 24-item scale was used to rate the patient's depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state).

Outcome measures

Outcome measures
Measure	Escitalopram Low Dose n=319 Participants Escitalopram low dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Escitalopram High Dose n=318 Participants Escitalopram high dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Placebo n=215 Participants Placebo, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8	-11.5 Units on a scale Standard Error 0.5	-11.6 Units on a scale Standard Error 0.6	-8.5 Units on a scale Standard Error 0.6

Adverse Events

Escitalopram Low Dose

Serious events: 3 serious events

Other events: 146 other events

Deaths: 0 deaths

Escitalopram High Dose

Serious events: 7 serious events

Other events: 160 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Escitalopram Low Dose n=322 participants at risk Escitalopram low dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Escitalopram High Dose n=324 participants at risk Escitalopram high dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Placebo n=218 participants at risk Placebo, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
General disorders Chest Pain	0.31% 1/322 • Number of events 1 • 10 months.	0.31% 1/324 • Number of events 1 • 10 months.	0.00% 0/218 • 10 months.
Infections and infestations Appendicitis	0.00% 0/322 • 10 months.	0.31% 1/324 • Number of events 1 • 10 months.	0.00% 0/218 • 10 months.
Infections and infestations Pharyngitis	0.31% 1/322 • Number of events 1 • 10 months.	0.00% 0/324 • 10 months.	0.00% 0/218 • 10 months.
Injury, poisoning and procedural complications Injury	0.00% 0/322 • 10 months.	0.00% 0/324 • 10 months.	0.46% 1/218 • Number of events 1 • 10 months.
Nervous system disorders Multiple Sclerosis	0.31% 1/322 • Number of events 1 • 10 months.	0.00% 0/324 • 10 months.	0.00% 0/218 • 10 months.
Psychiatric disorders Anxiety	0.00% 0/322 • 10 months.	0.62% 2/324 • Number of events 2 • 10 months.	0.00% 0/218 • 10 months.
Psychiatric disorders Suicidal ideation	0.00% 0/322 • 10 months.	0.31% 1/324 • Number of events 1 • 10 months.	0.46% 1/218 • Number of events 1 • 10 months.
Psychiatric disorders Suicide Attempt	0.00% 0/322 • 10 months.	0.31% 1/324 • Number of events 1 • 10 months.	0.00% 0/218 • 10 months.
Psychiatric disorders Depression	0.00% 0/322 • 10 months.	0.00% 0/324 • 10 months.	0.92% 2/218 • Number of events 2 • 10 months.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/322 • 10 months.	0.00% 0/324 • 10 months.	0.46% 1/218 • Number of events 1 • 10 months.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/322 • 10 months.	0.00% 0/324 • 10 months.	0.46% 1/218 • Number of events 1 • 10 months.
Vascular disorders Peripheral vascular disorder	0.00% 0/322 • 10 months.	0.31% 1/324 • Number of events 1 • 10 months.	0.00% 0/218 • 10 months.

Other adverse events

Other adverse events
Measure	Escitalopram Low Dose n=322 participants at risk Escitalopram low dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Escitalopram High Dose n=324 participants at risk Escitalopram high dose, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.	Placebo n=218 participants at risk Placebo, administered orally (QD \[once a day\]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Nervous system disorders Headache	16.1% 52/322 • 10 months.	13.9% 45/324 • 10 months.	14.2% 31/218 • 10 months.
Gastrointestinal disorders Nausea	12.7% 41/322 • 10 months.	11.4% 37/324 • 10 months.	7.3% 16/218 • 10 months.
Gastrointestinal disorders Diarrhea	9.3% 30/322 • 10 months.	10.8% 35/324 • 10 months.	6.4% 14/218 • 10 months.
Psychiatric disorders Insomnia	5.9% 19/322 • 10 months.	10.5% 34/324 • 10 months.	3.2% 7/218 • 10 months.
Gastrointestinal disorders Dry mouth	7.1% 23/322 • 10 months.	8.6% 28/324 • 10 months.	3.2% 7/218 • 10 months.
Nervous system disorders Somnolence	5.3% 17/322 • 10 months.	8.0% 26/324 • 10 months.	1.8% 4/218 • 10 months.
General disorders Fatigue	5.6% 18/322 • 10 months.	6.2% 20/324 • 10 months.	1.8% 4/218 • 10 months.
Nervous system disorders Dizziness	4.7% 15/322 • 10 months.	4.3% 14/324 • 10 months.	5.5% 12/218 • 10 months.
Infections and infestations Nasopharyngitis	1.9% 6/322 • 10 months.	3.7% 12/324 • 10 months.	5.0% 11/218 • 10 months.

Additional Information

Carl Gommoll, MS

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Phone: 201-427-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor can review results communications prior to public release \& can embargo communications re: results for 90 days from time submitted to sponsor for review. PI shall not disclose sponsor's confidential info. Upon sponsor's request, PI shall delete any proprietary info \& shall not include raw data in pub. On sponsor's request, PI shall delay submission for any pub while sponsor files patent apps. If trial is multi-center, PI agrees that first publication shall be a multi-center pub.
Publication restrictions are in place

Restriction type: OTHER