Major Depressive Disorder
Conditions
Interventions
Trade Name: CYMBALTA
Product Name: duloxetine hydrochloride
Product Code: LY248686
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the p
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
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that has not received regulatory approval for any indication at the time of study entry; Have previously completed or withdrawn from this study or any other study investigating duloxetine; Have any current and primary Axis I disorder other than MDD, including but not limited to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, or abstinence), barrier devices with or without spermicide are not considered to be an acceptable means of contraception; 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 ECT or 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of duloxetine 60 mg to 120 mg once daily (QD) compared with placebo in the prevention of depressive recurrences, as measured by time to recurrence, among patients with recurrent major depressive disorder (MDD) who have responded to duloxetine during a 4- to 10-week acute treatment period and a 22- to 24-week continuation treatment period.;Secondary Objective: To evaluate the efficacy of maintenance treatment with duloxetine compared with placebo as measured by: Recurrence rates, Time to >= 50% worsening in the 17-item HAMD17 and CGI-Severity >=3, Loss of response (HAMD17 >9 and CGI-Severity >2) at any time, HAMD17 total score, CGI-Severity scale, PGI-Improvement scale, HAMD subscales. -To assess the efficacy of maintenance treatment with duloxetine compared with placebo on quality of life and health outcome measures, as measured by: Sheehan Disability Scale (SDS), 36-item Short-Form Health Survey (SF-36), Resource Utilization and Hospitalization Module. To evaluate the safety and tolerability of maintenance treatment with duloxetine compared with placebo as measured by: TEAEs, Vital signs, Laboratory, Measurements, Arizona Sexual Experience Scale (ASEX). To assess the efficacy and safety of duloxetine during the 4- to 10-week, open-label, acute phase and the 22- to 24-week continuation phase, using the above measures (if applicable).;Primary end point(s): The measure for the primary objective is the time to recurrence as assessed during 52 to 54 weeks of maintenance treatment, in patients who have responded to up to 34 weeks of open-label duloxetine treatment (4 to10 weeks of acute treatment plus 22 to 24 weeks of continuation treatment). “Time to recurrence” is defined as the time from random assignment to the first visit during the maintenance phase at which the patient meets the recurrence criteria. | — |
Countries
Germany, Italy, Sweden
Outcome results
None listed