Escitalopram in Adult Patients With Major Depressive Disorder
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| ClinicalTrials.gov Identifier: NCT00668525 |
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Recruitment Status :
Completed
First Posted : April 29, 2008
Results First Posted : May 6, 2010
Last Update Posted : May 11, 2010
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Sponsor:
Forest Laboratories
Information provided by:
Forest Laboratories
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depressive Disorder | Drug: Escitalopram Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 877 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 2
Escitalopram low dose
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Drug: Escitalopram
Escitalopram low dose, oral administration, once daily dosing for 8 weeks. |
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Experimental: 3
Escitalopram high dose
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Drug: Escitalopram
Escitalopram high dose, oral administration, once daily dosing for 8 weeks |
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Placebo Comparator: 1
Placebo
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Drug: Placebo
Placebo, oral administration, once daily dosing for 8 weeks |
Primary Outcome Measures :
- 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).
Secondary Outcome Measures :
- 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).
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
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
Locations
| United States, Arizona | |
| Forest Investigative Site | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Forest Investigative Site | |
| Arcadia, California, United States, 91007 | |
| Forest Investigative Site | |
| Encino, California, United States, 91316 | |
| Forest Investigative Site | |
| Garden Grove, California, United States, 92845 | |
| Forest Investigative Site | |
| Irvine, California, United States, 92618 | |
| Forest Investigative Site | |
| Los Alamitos, California, United States, 90720 | |
| United States, Colorado | |
| Forest Investigative Site | |
| Denver, Colorado, United States, 80212 | |
| United States, District of Columbia | |
| Forest Investigative Site | |
| Washington, District of Columbia, United States, 20016 | |
| United States, Florida | |
| Forest Investigative Site | |
| Bradenton, Florida, United States, 34208 | |
| Forest Investigative Site | |
| Jacksonville, Florida, United States, 32216 | |
| Forest Investigative Site | |
| Orlando, Florida, United States, 32806 | |
| Forest Investigative Site | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Forest Investigative Site | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Kansas | |
| Forest Investigative Site | |
| Newton, Kansas, United States, 67114 | |
| Forest Investigative Site | |
| Overland, Kansas, United States, 66221 | |
| United States, Maryland | |
| Forest Investigative Site | |
| Baltimore, Maryland, United States, 21208 | |
| Forest Investigative Site | |
| Glen Burnie, Maryland, United States, 21061 | |
| Forest Investigative Site | |
| Rockville, Maryland, United States, 20852 | |
| United States, Michigan | |
| Forest Investigative Site | |
| Okemos, Michigan, United States, 48864 | |
| United States, Missouri | |
| Forest Investigative Site | |
| St. Louis, Missouri, United States, 63044 | |
| United States, Nebraska | |
| Forest Investigative Site | |
| Omaha, Nebraska, United States, 68131 | |
| Forest Investigative Site | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| Forest Investigative Site | |
| Cherry Hill, New Jersey, United States, 08002 | |
| Forest Investigative Site | |
| Clementon, New Jersey, United States, 08021 | |
| United States, New York | |
| Forest Investigative Site | |
| Bronx, New York, United States, 10467 | |
| Forest Investigative Site | |
| Brooklyn, New York, United States, 11235 | |
| Forest Investigative Site | |
| New York, New York, United States, 10021 | |
| Forest Investigative Site | |
| New York, New York, United States, 10024 | |
| Forest Investigative Site | |
| Staten Island, New York, United States, 10312 | |
| United States, Ohio | |
| Forest Investigative Site | |
| Canton, Ohio, United States, 44708 | |
| Forest Investigative Site | |
| Dayton, Ohio, United States, 45408 | |
| United States, Oregon | |
| Forest Investigative Site | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Forest Investigative Site | |
| Media, Pennsylvania, United States, 19063 | |
| Forest Investigative Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Forest Investigative Site | |
| Charleston, South Carolina, United States, 29405 | |
| United States, Tennessee | |
| Forest Investigative Site | |
| Memphis, Tennessee, United States, 38117 | |
| Forest Investigative Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Forest Investigative Site | |
| Austin, Texas, United States, 78756 | |
| Forest Investigative Site | |
| Houston, Texas, United States, 77008 | |
| Forest Investigative Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Forest Investigative Site | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Vermont | |
| Forest Investigative Site | |
| Woodstock, Vermont, United States, 05091 | |
| United States, Virginia | |
| Forest Investigative Site | |
| Richmond, Virginia, United States, 23230 | |
| United States, Washington | |
| Forest Investigative Site | |
| Bellevue, Washington, United States, 98004 | |
| Forest Investigative Site | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
Forest Laboratories
Investigators
| Study Director: | Carl Gommoll, MS | Forest Laboratories |
| Responsible Party: | Carl Gommoll, Study Director, Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT00668525 |
| Other Study ID Numbers: |
SCT-MD-49 |
| First Posted: | April 29, 2008 Key Record Dates |
| Results First Posted: | May 6, 2010 |
| Last Update Posted: | May 11, 2010 |
| Last Verified: | May 2010 |
Keywords provided by Forest Laboratories:
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Depression Major Depressive Disorder Escitalopram |
Additional relevant MeSH terms:
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Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Dexetimide Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |