Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

• Conditions: Major Depressive Disorder; MedDRA version: 8.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episode

• Registration Number: EUCTR2004-000167-95-DE
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Patients may be included in the study only if they meet all of the following criteria:
Are male or female outpatients at least 18 years of age, have signed and dated the informed consent document (ICD), Meet criteria for recurrent major depressive disorder (MDD), without psychotic features, as defined by DSM-IV and as assessed by the MINI, Must have had at least three episodes of depression, including the current episode, within the past 5 years, Were in remission between episodes of depression in the opinion of the investigator, and have been stable and off antidepressant medication for at least 2 months prior to the onset of the current episode, Have a HAMD17 total score of >=18 at Visits 1 and 2, Have a CGI-Severity score of >=4 at Visits and 2, Have a level of understanding sufficient to provide informed consent and to communicate with the investigators and site personnel, Are judged to be reliable, agree to keep all appointments as required by the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients must be excluded from the study for any of the following criteria: Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study; Are employed by Lilly or Boerhinger Ingelheim (BI). 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; 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that has not received regulatory approval for any indication at the time of study entry; Have previously completed or withdrawn from this study or any other study investigating duloxetine; Have any current and primary Axis I disorder other than MDD, including but not limited to dysthymia; Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders; Have any anxiety disorder as a primary diagnosis within the past year (including panic disorder, agoraphobia, obsessive-compulsive disorder [OCD], posttraumatic stress disorder [PTSD], generalized anxiety disorder [GAD], and social phobia, but excluding specific phobias); Have the presence of an Axis II disorder, which, in the judgment of the investigator, would interfere with compliance with the study protocol; Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine; Have a positive urine drug screen for any substances of abuse, including benzodiazepines (at Visit 1). Note: If the patient has a positive drug screen at Visit 1, a retest may be performed prior to Visit 2 if, in the judgment of the investigator, there is an acceptable explanation for the positive result. If the retest is positive for active metabolites, the investigator must document that the patient has discontinued taking the medication. If the retest is positive for the parent compound, the patient will be excluded; Are women who are pregnant or breastfeeding and women of childbearing potential who are not using a medically-accepted means of contraception when engaging in sexual intercourse (for example, intrauterine device, oral contraceptive, implant, Depo-Provera, barrier devices with spermicide, or abstinence); Demonstrate lack of response of the current episode of MDD to two or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression; Are patients judged to be at serious suicidal risk in the opinion of the investigator, and/or if the patient’s HAMD17 score on Item 3 Suicide is >3 at Visit 1 and Visit 2; Have serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require intervention/hospitalization/excluded medication during the course of the study; Have had electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the past year; Have initiated or stopped psychotherapy within 6 weeks prior to enrollment or at any time during the study. Patients who initiate psychotherapy more than 6 weeks before enrollment may continue in therapy if, in the investigator's judgment, the therapy is not in its active phase. This judgment may be made by inquiring whether there has been a change in the frequency of visits at the time of study enrollment, a stressful event, or change in the patie

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified