Patients with Major Depressive Disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR
Conditions
Interventions
Product Code: LY2216684
Pharmaceutical Form: Tablet
Current Sponsor code: LY2216684
Other descriptive name: LY2216684 hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult men or women at least 18 to 65 years of age at informed consent, who provide informed consent by signing the appropriate ICDs. Patients must be competent and able to give their own informed consent. [2] Meet criteria for MDD as defined by DSM-IV-TR criteria without psychotic features, as determined by clinical assessment and confirmed by the MINI at Visit 1. Have had at least one other major depressive episode prior to the current episode. [3] Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) may participate in the study. Women must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study. [4] Have a GRID-HAMD17 total score =18 at Visit 1 and Visit 2. [5] Have a CGI-Severity score =4 at Visit 1 and Visit 2. [6] Have an education level and a degree of understanding such that the patient can communicate with the site study personnel. [7] Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: * Have previously completed or withdrawn from this study or any other study investigating LY2216684. * Have had or currently have any additional ongoing DSM-IV-TR Axis I condition other than major depression that was considered the primary diagnosis within 1 year of Visit 1. *Have had any anxiety disorder preceding the onset of depression that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias). *Have an Axis II disorder which, in the judgment of the investigator, would interfere with compliance with the study protocol. *Have a current or previous diagnosis of Bipolar I or II Disorder, psychotic depression, schizophrenia, or other psychotic disorder *Women who are pregnant or breast-feeding. *Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the patient has treatment-resistant depression. *Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others. *Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension or unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitancy or retention. *Have received treatment with a monoamine oxidase inhibitor within 14 days prior to Visit 1 or have a potential need to use a monoamine oxidase inhibitor within 14 days after discontinuation from the study. *Have received treatment with fluoxetine within 30 days prior to Visit 2. *Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or psychosurgery within the last year *Have a history of any seizure disorder (other than febrile seizures). *Require psychotropic medication other than sedative/hypnotic medication for sleep as specified in the protocol. *Have a thyroid stimulating hormone (TSH) level outside the laboratory established reference range. Patients previously diagnosed with hyperthyroidism or hypothyroidism who have been treated with a stable dose of thyroid supplement for at least the past 3 months, and who are clinically and chemically euthyroid, will be allowed to participate in the study. *Have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether LY2216684 is superior to placebo in the treatment of patients with MDD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR; APA 2004), during a 10-week, double-blind, acute treatment phase. Superiority is defined as a statistically greater reduction in depressive symptoms from baseline to endpoint as measured by the 16-Item Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR16) total score.;Secondary Objective: To assess whether LY2216684 is superior to placebo in the acute treatment of patients with MDD in improving global function as measured by change from baseline to endpoint in the Sheehan Disability Scale (SDS) Global Functional Impairment score (Sheehan 1983). ;Primary end point(s): Baseline is defined as the last measurement taken at, or prior to, randomization (Visit 2); endpoint is defined as the last nonmissing measurement taken in Study Period II (at or before Visit 7); last visit is defined as the visit where the endpoint is assessed. For analyses of Study Period II, baseline is defined as the last non-missing observation at or before the randomization visit (Visit 2) unless otherwise specified. Endpoint for Study Period II is defined as the last non-missing observation obtained from Visit 3 through Visit 7. Baseline for Study Period III is defined as the observation from Visit 7. Endpoint for Study Period III is defined as the last nonmissing observation obtained from Visit 8 through Visit 20. Baseline for Study Period IV is defined as the last nonmissing observation obtained in Study Period II or III prior to entering Study Period IV (Visit 4 through Visit 20). Endpoint for Study Period IV is defined as Visit 21. | — |
Countries
Finland
Outcome results
None listed