Escitalopram in Adult Patients With Major Depressive Disorder
|ClinicalTrials.gov Identifier: NCT00668525|
Recruitment Status : Completed
First Posted : April 29, 2008
Results First Posted : May 6, 2010
Last Update Posted : May 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Escitalopram Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||877 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||February 2009|
Active Comparator: 2
Escitalopram low dose
Escitalopram low dose, oral administration, once daily dosing for 8 weeks.
Escitalopram high dose
Escitalopram high dose, oral administration, once daily dosing for 8 weeks
Placebo Comparator: 1
Placebo, oral administration, once daily dosing for 8 weeks
- Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks. [ Time Frame: Change from baseline in MADRS total score at week 8 ]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 Hamiltion Rating Scale for Depression (HAM-D) at Week 8 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668525
Show 45 Study Locations
|Study Director:||Carl Gommoll, MS||Forest Laboratories|