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
• Sponsor: Forest Laboratories
• Information provided by: Forest Laboratories

Tracking Information

• First Submitted Date: April 28, 2008
• First Posted Date: April 29, 2008
• Results First Submitted Date: March 22, 2010
• Results First Posted Date: May 6, 2010
• Last Update Posted Date: May 11, 2010
• Study Start Date: April 2008
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Escitalopram in Adult Patients With Major Depressive Disorder
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 12, 2010): 877
• Original Estimated Enrollment (submitted: April 28, 2008): 800
• Study Completion Date: Not Provided
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00668525
• Other Study ID Numbers: SCT-MD-49
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Carl Gommoll, Study Director, Forest Laboratories
• Study Sponsor: Forest Laboratories
• Collaborators: Not Provided

Investigators

• Study Director: Carl Gommoll, MS; Forest Laboratories

• PRS Account: Forest Laboratories
• Verification Date: May 2010