- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00191932
Switching to Duloxetine From Other Antidepressants
July 21, 2006 updated by: Eli Lilly and Company
Switching to Duloxetine From Other Antidepressants: A Regional Multicentre Trial Comparing Two Switching Techniques
A multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression.
The study compares outcomes associated with two methods of switching from current antidepressant to duloxetine
Study Overview
Study Type
Interventional
Enrollment
360
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Caen, France
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Cherbourg, France
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Palaiseau, France
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Paris Cedex 14, France
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Rennes, France
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
-
-
-
Belfast, Ireland
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
-
-
-
Barcelona, Spain
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Madrid, Spain
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Ourense, Spain
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Salamanca, Spain
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Zamora, Spain
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
-
-
-
Haywards Heath, United Kingdom
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Horsham, United Kingdom
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Wythenshawe, United Kingdom
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female outpatients of at least 18 years of age, who meet criteria for Major Depressive Disorder (MDD)
- Currently non- or only partially-responsive to an SSRI antidepressant after at least 5 weeks of treatment
Exclusion Criteria include:
- Current primary Axis I disorder other than MDD
- Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
- Patients judged to be at serious suicidal risk.
- Serious medical illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To test the hypothesis that the efficacy associated with direct switch from SSRI to duloxetine is non-inferior to start-taper switch
|
Secondary Outcome Measures
Outcome Measure |
---|
To compare the efficacy, health outcomes, safety and tolerability associated with the above two switching methods, as measured by HAMD17, CGI-S, PGI-I, SF-36, spontaneously reported adverse events , vital signs and other measures.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Study Completion
March 1, 2006
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
July 25, 2006
Last Update Submitted That Met QC Criteria
July 21, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Mood Disorders
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
Other Study ID Numbers
- 8604 (CTEP)
- F1J-MC-HMDG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Duloxetine
-
Shanghai Mental Health CenterJiangsu Nhwa Pharmaceutical Co., Ltd.Completed
-
Boehringer IngelheimCompletedDiabetic Neuropathies | Depressive Disorder, MajorGermany
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RecruitingMajor Depressive Disorder (MDD)China
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Completed
-
University of MinnesotaHoffmann-La Roche; Minnesota Medical FoundationCompleted
-
University of PittsburghEli Lilly and Company; National Institutes of Health (NIH)CompletedBack Pain | Major Depressive Disorder | AgedUnited States
-
Hamilton Health Sciences CorporationSt. Joseph's Healthcare Hamilton; Eli Lilly and Company; McMaster UniversityUnknown
-
New York State Psychiatric InstituteEli Lilly and CompanyCompletedDysthymic Disorder | Depressive Disorder NOSUnited States
-
Boehringer IngelheimCompleted
-
Eli Lilly and CompanyShionogiCompleted