Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients
This study has been completed.
Sponsor:
Forest Laboratories
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00384436
First received: October 3, 2006
Last updated: January 3, 2008
Last verified: January 2008
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Purpose
The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: escitalopram |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients |
Resource links provided by NLM:
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Time to premature discontinuation
Secondary Outcome Measures:
- Montgomery Asberg Depression Rating Scale (MADRS)
| Estimated Enrollment: | 580 |
| Study Start Date: | October 2006 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the safety and efficacy of escitalopram and an active comparator in severely depressed patients.
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 DSM-IV criteria for Major Depressive Disorder.
- Patients must have severe depression.
- MADRS greater than or equal to 30
Exclusion Criteria:
- Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
- Patients who are considered a suicide risk.
- Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia.
- Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder.
- Patients with history of any psychotic disorder or any psychotic feature.
Contacts and Locations More Information
No publications provided by Forest Laboratories
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00384436 History of Changes |
| Other Study ID Numbers: | SCT-MD-39 |
| Study First Received: | October 3, 2006 |
| Last Updated: | January 3, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Forest Laboratories:
|
Major Depressive Disorder |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 22, 2013