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Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder
This study is currently recruiting participants.
Verified by Eli Lilly and Company, December 2008
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00810069
  Purpose

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:

  1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
  2. that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy

Condition Intervention Phase
Major Depressive Disorder
Drug: Duloxetine Hydrochloride
Drug: Escitalopram
Phase IV

MedlinePlus related topics: Depression
Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Duloxetine Duloxetine hydrochloride
U.S. FDA Resources
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to confirmed response by ≥ 50% change from baseline reduction in Hamilton Depression Rating Scale (HAMD17) [ Time Frame: Between the week 4 and the week 16 ] [ Designated as safety issue: No ]
  • Time to confirmed remission by a HAMD17 score of ≤ 7 that is maintained for two consecutive visits. [ Time Frame: Between the week 4 and the week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to confirmed response as defined by ≥ 50% reduction from baseline reduction in Quick Inventory of Depressive Symptomatology (QIDS-SR)that is reported for two consecutive visits [ Time Frame: Between the week 4 and the week 16 ] [ Designated as safety issue: No ]
  • Time to confirmed remission as defined by a QIDS-SR score of ≤5 that is maintained for two consecutive visits. [ Time Frame: Between the week 4 and the week 16 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Severity Scale [ Time Frame: baseline, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks ] [ Designated as safety issue: No ]
  • Visual Analog Scale - pain Pain improvement of subjects presenting with at least a modest level of pain as indicated by a baseline VAS score of > 30. [ Time Frame: baseline, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks, 16 weeks ] [ Designated as safety issue: No ]
  • Quality of life changes on EQ-5D scale [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
  • Functional improvement on Sheehan Disability Scale (SDS). [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
  • Resource utilisation data (direct and indirect costs of both intervention strategies) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks ] [ Designated as safety issue: No ]
  • Unsolicited Treatment Emergent Adverse Events and Serious Adverse Events collection to compare safety between the two treatment strategies [ Time Frame: Between the baseline and the week 16 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female outpatients of at least 18 years of age who meet criteria for MDD, single or recurrent episode according to the DSM-IV®-TR disease diagnostic criteria.
  2. Patients (receiving or not antidepressant treatment) who, based on investigator criteria, initiate treatment with escitalopram or change their current AD treatment to escitalopram for this current MDD episode, at the initial visit.
  3. Must have a baseline score of ≥19 on the HAM-D17 at the initial visit.
  4. Must have a baseline score of ≥ 4 in the Clinical Global Impression- Severity (CGI-S) at the initial visit.
  5. Have a level of understanding sufficient to provide ICD, and to communicate with the investigators and site personnel.
  6. Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.

    Exclusion Criteria:

  7. Have any current primary Axis I disorder other than MDD, including but not limited to dysthymia.
  8. Have a diagnosis of dementia, Alzheimer's disease, or organic brain syndrome; or who are cognitively impaired or who have language problems that prevent them from understanding and/or providing valid answers to the rating scale contents.
  9. Concomitant participation in other studies with investigational or marketed products.
  10. Are not expected to be able to be monitored throughout the entire study period for reasons unrelated to their illness (for instance, change of residence or healthcare center of reference).
  11. Are demonstrating a response or demonstrated a response to the AD treatment for the current depression episode previous to baseline visit.
  12. Are investigator site personnel directly affiliated with this study and/or their immediate families. "Immediate family" is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  13. Are employed by Lilly or Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or BI employees may participate in Lilly or BI-sponsored clinical trials, but are not permitted to participate at a Lilly or BI facility. "Immediate family" is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  14. Women of childbearing potential who are not using a medically accepted means of contraception (for example, intrauterine device, oral contraceptive, contraceptive patch, implant, Depo-Provera [medroxyprogesterone acetate injectable suspension, Pharmacia & Upjohn], or barrier devices) when engaging in sexual intercourse. Women who are pregnant or breast-feeding may not participate in the study.
  15. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  16. Are judged to be at serious suicidal risk in the opinion of the investigator, and/or if the patient's baseline (visit 1) HAMD17 scores on item 3 suicide are 3.
  17. Have been treated with a monoamine oxidase inhibitor (MAOI) within 14 days prior to visit 1 or potential need to use an MAOI during the study or within 5 days after discontinuation of study drug.
  18. Require initiation or discontinuation of psychotherapy within 6 weeks prior to enrollment (visit 1) or at any time during the study.
  19. Have any contraindication for the use of duloxetine based on Duloxetine Summary of Product Characteristics or any contraindication for the use of escitalopram based on Escitalopram SPC.
  20. Have a history of lack of response to duloxetine or escitalopram at a clinically appropriate dose for a minimum of 4 weeks, or have previously completed or withdrawn from this study or any other study investigating duloxetine or escitalopram.
  21. Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
  22. Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
  23. Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
  24. Have had ECT or Transcranial Magnetic Stimulation within the past year.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810069

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) 1-317-615-4559

Locations
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

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

Keywords provided by Eli Lilly and Company:
Major Depressive Disorder
MDD
Depression

Study placed in the following topic categories:
Dopamine
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Dexetimide
Depressive Disorder
Citalopram
Serotonin
Duloxetine
Behavioral Symptoms

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009