Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Eli Lilly and Company |
---|---|
Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00810069 |
This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention.
Two hypothesis will be tested:
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder |
Drug: Duloxetine Hydrochloride Drug: Escitalopram |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment |
Official Title: | Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy |
Estimated Enrollment: | 580 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Early Intervention: Experimental
Duloxetine flexible dose (60 or 120 mg daily) for 12 weeks
|
Drug: Duloxetine Hydrochloride
Flexible dose of 60 or 120 mg daily
|
Delayed Intervention: Experimental
Escitalopram flexible dose (10 or 20 mg daily)for 4 weeks followed by duloxetine flexible dose (60 or 120 mg daily) for 8 weeks
|
Drug: Duloxetine Hydrochloride
Flexible dose of 60 or 120 mg daily
Drug: Escitalopram
Flexible dose of 10 or 20 mg daily
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.
Exclusion Criteria:
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) | 1-317-615-4559 |
France | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician | Recruiting |
Angouleme, France | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician | Recruiting |
Orvault, France | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician | Recruiting |
Rennes, France | |
Sweden | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician | Recruiting |
Stockholm, Sweden | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician | Recruiting |
Lund, Sweden |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM Esastern time (UTC/GMT-5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli LIlly ( Chief Medical Officer ) |
Study ID Numbers: | 12329, F1J-EW-HMGD |
Study First Received: | December 16, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00810069 |
Health Authority: | Denmark: Danish Medicines Agency; Denmark: Ethics Committee; France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Greece: Ethics Committee; Greece: National Organization of Medicines; Hungary: National Institute of Pharmacy; Italy: Ethics Committee; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Romania: National Medicines Agency; Slovenia: Ethics Committee; Slovenia: Agency for Medicinal Products - Ministry of Health; Spain: Ethics Committee; Spain: Spanish Agency of Medicines; Sweden: Regional Ethical Review Board; Sweden: Medical Products Agency; Turkey: Ethics Committee; Turkey: Ministry of Health |
Major Depressive Disorder MDD Depression |
Dopamine Depression Mental Disorders Mood Disorders Depressive Disorder, Major Dexetimide |
Depressive Disorder Citalopram Serotonin Duloxetine Behavioral Symptoms |
Dopamine Uptake Inhibitors Parasympatholytics Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Anti-Dyskinesia Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Pathologic Processes Therapeutic Uses Antidepressive Agents, Second-Generation Antidepressive Agents Disease Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |