Major depressive disorder (MDD) MedDRA version: 12.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS
Conditions
Interventions
Product Name: LY2216684
Product Code: LY2216684
Pharmaceutical Form: Tablet
Current Sponsor code: LY2216684
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
Curr
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Meet criteria for a primary MDD without psychotic features, as defined by DSM-IV-TR criteria, as determined by clinical assessment and confirmed by the MINI at Visit 1. [2] Are adult male or female outpatients at least 18 years of age or older at the time of informed consent, who provide informed consent by signing the appropriate ICFs. Patients must be competent and able to give their own informed consent. [3] Women of child-bearing potential (not surgically sterilized and between menarche and 1 year after menopause) may participate in the study. Women must test negative for pregnancy at the time of study entry 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 and for 1 month following the last dose of investigational product. Men participating agree to use a reliable method of birth control during the study. [4] Are being treated with one of the following SSRIs that have been approved for MDD treatment within the participating country: escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; and have been treated with their SSRI at least 6 weeks prior to Visit 2 with at least the last 4 consecutive weeks at a stable optimized dose prior to Visit 2. The SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country. [5] Meet criteria for partial response at Visit 1 and Visit 2, as defined by investigator’s opinion that the patient has experienced a minimally clinically meaningful improvement with the SSRI treatment. The purpose of this inclusion criterion is to ensure partial responders are enrolled. [6] Have a GRID-HAMD17 total score =16 at Visits 1 and 2. [7] Have =75% improvement on the current SSRI at Visit 1, determined by the MGH-ATRQ-Modified version. [8] Have an education level and a degree of understanding such that the patient can communicate with the site study personnel. [9] Are 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [10] 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. [11] Are Lilly employees. [12] Are currently enrolled in, or discontinued within the last 30 days from, a clinical study involving an investigational drug or device, or participate in the off-label use of a drug or device (other than the investigational product used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [13] Have previously completed or withdrawn from this study or any other study investigating LY2216684. [14] 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. [15] Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder [OCD], posttraumatic stress disorder [PTSD], generalized anxiety disorder [GAD], and social phobia, but excluding specific phobias). [16] Have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder. [17] Have a history of substance abuse within the past 1 year (drug categories defined by DSM-IV-TR), and/or substance dependence within the past 1 year, not including caffeine and nicotine. [18] Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol. [19] Have had a lack of full 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, have treatment-resistant depression. [20] Have a lifetime treatment history of vagal nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or psychosurgery. [21] Have received electroconvulsive therapy (ECT) in the past year [22] Are women who are pregnant or breastfeeding. [23] Are judged, in the opinion of the investigator, to be at serious risk for harm to self or others. [24] Have a serious or unstable medical illness, including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or ECG abnormality. Clinically significant laboratory or ECG abnormalities are those which, in the judgment of the investigator, indicate a serious medical problem or require significant intervention. [25] Have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension or unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitancy or retention. [26] Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions. [27] Have a history of any seizure disorder (other than febrile seizures). [28] Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1 or have a potential need to use an MAOI within 3 days after discontinuation from the study. [29] Require psychotropic medication other than sedative/hypnotic medication for sleep, as specified in the protocol. [30] Are taking or have received treatment with any excluded medications within 7 days prior to Visit 2. [31]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess whether at least one dose of LY2216684 (12 mg or 18 mg once daily [QD]) is superior to placebo QD in the adjunctive treatment of patients with major depressive disorder (MDD; as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR) who were identified as partial responders to an adequate course of treatment with a selective serotonin reuptake inhibitor (SSRI), during an 11-week, double-blind, acute adjunctive treatment phase. Superiority is defined as a statistically greater reduction in depressive symptoms from baseline to the last visit in the adjunctive treatment phase, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score.;Secondary Objective: - to assess whether LY2216684 12 mg or 18 mg QD is superior to placebo as an adjunctive treatment for patients with MDD in improving global functioning. - to assess whether LY2216684 12 mg or 18 mg QD is superior to placebo as an adjunctive treatment for patients with MDD in improving the impact of fatigue on functioning - to assess whether LY2216684 12 mg or 18 mg QD is superior to placebo as an adjunctive treatment for patients with MDD in achieving remission at the last visit in the adjunctive treatment phase. - to assess whether LY2216684 12 mg or 18 mg QD is superior to placebo as an adjunctive treatment for patients with MDD who are partial responders to their SSRI treatment in achieving sustained remission in the adjunctive treatment phase. - to assess whether LY2216684 12 mg or 18 mg QD is superior to placebo as an adjunctive treatment for patients with MDD in improving anxiety symptoms;Primary end point(s): The endpoint for Study Period II is defined as the last nonmissing observation obtained after the randomization visit through Visit 11. The endpoint for Study Period III is defined as Visit 301. | — |
Countries
Latvia
Outcome results
None listed