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Escitalopram in Adult Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00668525
Recruitment Status : Completed
First Posted : April 29, 2008
Results First Posted : May 6, 2010
Last Update Posted : May 11, 2010
Sponsor:
Information provided by:
Forest Laboratories

Tracking Information
First Submitted Date  ICMJE April 28, 2008
First Posted Date  ICMJE April 29, 2008
Results First Submitted Date  ICMJE March 22, 2010
Results First Posted Date  ICMJE May 6, 2010
Last Update Posted Date May 11, 2010
Study Start Date  ICMJE April 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2010)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2008)
Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 8 ]
Change History Complete list of historical versions of study NCT00668525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2010)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2008)
Hamiltion Rating Scale for Depression (HAM-D) [ Time Frame: Week 8 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram in Adult Patients With Major Depressive Disorder
Official Title  ICMJE A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 2
    Escitalopram low dose
    Intervention: Drug: Escitalopram
  • Experimental: 3
    Escitalopram high dose
    Intervention: Drug: Escitalopram
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2010)
877
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2008)
800
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00668525
Other Study ID Numbers  ICMJE SCT-MD-49
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carl Gommoll, Study Director, Forest Laboratories
Study Sponsor  ICMJE Forest Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Carl Gommoll, MS Forest Laboratories
PRS Account Forest Laboratories
Verification Date May 2010

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