Escitalopram in Adult Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00668525
First received: April 28, 2008
Last updated: May 7, 2010
Last verified: May 2010

April 28, 2008
May 7, 2010
April 2008
February 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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).
Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00668525 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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).
Hamiltion Rating Scale for Depression (HAM-D) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Escitalopram in Adult Patients With Major Depressive Disorder
A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder

This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Escitalopram
    Escitalopram low dose, oral administration, once daily dosing for 8 weeks.
  • Drug: Placebo
    Placebo, oral administration, once daily dosing for 8 weeks
  • Drug: Escitalopram
    Escitalopram high dose, oral administration, once daily dosing for 8 weeks
  • Active Comparator: 2
    Escitalopram low dose
    Intervention: Drug: Escitalopram
  • Experimental: 3
    Escitalopram high dose
    Intervention: Drug: Escitalopram
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
877
Not Provided
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.
  • The patient's current depressive episode must be at least 8 weeks in duration.

Exclusion Criteria:

  • Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
  • Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
  • Patients who are considered a suicide risk
  • Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00668525
SCT-MD-49
No
Carl Gommoll, Study Director, Forest Laboratories
Forest Laboratories
Not Provided
Study Director: Carl Gommoll, MS Forest Laboratories
Forest Laboratories
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP