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Escitalopram in Adult Patients With Major Depressive Disorder
This study is ongoing, but not recruiting participants.
First Received: April 28, 2008   Last Updated: January 22, 2009   History of Changes
Sponsor: Forest Laboratories
Information provided by: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00668525
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Escitalopram
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Double-Blind, Fixed-Dose Study of Escitalopram in Adult Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamiltion Rating Scale for Depression (HAM-D) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: April 2008
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Active Comparator
Escitalopram low dose
Drug: Escitalopram
Escitalopram low dose, oral administration, once daily dosing for 8 weeks.
3: Experimental
Escitalopram high dose
Drug: Escitalopram
Escitalopram high dose, oral administration, once daily dosing for 8 weeks
1: Placebo Comparator
Placebo
Drug: Placebo
Placebo, oral administration, once daily dosing for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668525

  Show 45 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Carl Gommoll, MS Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories ( Carl Gommoll, Study Director )
Study ID Numbers: SCT-MD-49
Study First Received: April 28, 2008
Last Updated: January 22, 2009
ClinicalTrials.gov Identifier: NCT00668525     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Depression
Major Depressive Disorder
Escitalopram

Additional relevant MeSH terms:
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010