Escitalopram in Adult Patients With Major Depressive Diso... | NCT00668525

Status Module

Label	Type	Description	Intervention Names
2	Active Comparator	Escitalopram low dose	Drug: Escitalopram
3	Experimental	Escitalopram high dose	Drug: Escitalopram
1	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug	Escitalopram low dose, oral administration, once daily dosing for 8 weeks.	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.	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).	Change from baseline in MADRS total score at week 8

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Hamiltion Rating Scale for Depression (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).

Eligibility Module

Name	Affiliation	Role
Carl Gommoll, MS	Forest Laboratories	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Forest Investigative Site		Phoenix	Arizona	85016	United States
Forest Investigative Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	Escitalopram High Dose

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.

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).

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.

Posted

Mar 2010

Mean

Standard Error

Units on a scale

Change from baseline in MADRS total score at week 8

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG000319 OG001318 OG002215

Title

Denominators

Categories

Title	Measurements
	OG000-12.8± 0.6(-4.6 to -1.2) OG001-13.4± 0.6(-1.9 to 1.1) OG002-10.1± 0.7(-5.0 to -1.6)

Secondary

Change From Baseline in Hamiltion Rating Scale for Depression (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).

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 HAMD total score as a covariate.

Posted

Mar 2010

Mean

Standard Error

Units on a scale

Change from baseline in HAM-D at week 8

ID	Title	Description
OG000	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.
OG001	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.
OG002

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	3	322	146	322
EG001	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.	7	324	160	324
EG002	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.	4	218	74	218

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chest Pain	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected322 at risk EG0011 events1 affected324 at risk EG0020 events0 affected218 at risk
Appendicitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected322 at risk EG0011 events1 affected324 at risk EG0020 events0 affected218 at risk
Pharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected322 at risk EG0010 events0 affected324 at risk EG0020 events0 affected218 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected322 at risk EG0010 events0 affected324 at risk EG0021 events1 affected218 at risk
Multiple Sclerosis	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected322 at risk EG0010 events0 affected324 at risk EG0020 events0 affected218 at risk
Anxiety	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected322 at risk EG0012 events2 affected324 at risk EG0020 events0 affected218 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected322 at risk EG0011 events1 affected324 at risk EG0021 events1 affected218 at risk
Suicide Attempt	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 events0 affected322 at risk EG0011 events1 affected324 at risk EG0020 events0 affected218 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected322 at risk EG0010 events0 affected324 at risk EG0022 events2 affected218 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected322 at risk EG0010 events0 affected324 at risk EG0021 events1 affected218 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected322 at risk EG0010 events0 affected324 at risk EG0021 events1 affected218 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected322 at risk EG0011 events1 affected324 at risk EG0020 events0 affected218 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00052 affected322 at risk EG00145 affected324 at risk EG00231 affected218 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00041 affected322 at risk EG00137 affected324 at risk EG00216 affected218 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00030 affected322 at risk EG00135 affected324 at risk EG00214 affected218 at risk
Insomnia	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG00019 affected322 at risk EG00134 affected324 at risk EG0027 affected218 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00023 affected322 at risk EG00128 affected324 at risk EG0027 affected218 at risk
Somnolence	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00017 affected322 at risk EG00126 affected324 at risk EG0024 affected218 at risk
Fatigue	General disorders	MedDRA (11.0)	Systematic Assessment	EG00018 affected322 at risk EG00120 affected324 at risk EG0024 affected218 at risk
Dizziness	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00015 affected322 at risk EG00114 affected324 at risk EG00212 affected218 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0006 affected322 at risk EG00112 affected324 at risk EG00211 affected218 at risk

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds