Major depressive disorder (MDD) MedDRA version: 14.0 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 10037175 - Psychiatric disorders
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-
Pro
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Meet criteria for MDD, as defined by DSM-IV-TR criteria without psychotic features, as determined by clinical assessment by the MINI and confirmed by the physician at Visit 1. [2] Are adult men or women at least 18 years of age or older at 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 postmenopause) 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. The prescribed SSRI and its dose should be in accordance with labeling guidelines within the participating country. [5] Meet criteria for partial response at Visit 1 and Visit 2, as deemed by investigator’s opinion that the patient has experienced a minimal clinically meaningful improvement with SSRI. [6] Have a GRID HAMD17 total score =16 at Visit 1 and Visit 2. [7] Have =75% improvement on the current SSRI at Visit 1 determined by the MGH ATRQ. [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 600 F.1.3 Elderly (>=65 years) yes 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: [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 off-label use of a drug or device (other than the investigational product used in this study), or 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 MDD 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 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. [20] Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or psychosurgery within the last year. [21] Women who are pregnant or breastfeeding. [22] Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others. [23] Have a serious or unstable medical illness, including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic disease, renal disease, or clinically significant laboratory or ECG abnormality. Clinically significant lab or ECG abnormalities are those which, in the judgment of the investigator, indicate a serious medical problem or require significant intervention. [24] 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 history of urinary hesitancy or retention. [25] Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions. [26] Have a history of any seizure disorder (other than febrile seizures). [27] 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. [28] Require psychotropic medication other than sedative/hypnotic medication for sleep as specified in the protocol or other than the current SSRI [29] Are taking or have received treatment with any e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Not Applicable;Main Objective: The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in patients with major depressive disorder (MDD) who are partial responders to their SSRI treatment. The safety measures include the collection and reporting of discontinuation rates, treatment-emergent adverse events (TEAEs), vital signs, weight, electrocardiograms (ECGs), and laboratory analysis.;Secondary Objective: -To evaluate the safety and tolerability of LY2216684 as an adjunctive treatment for patients with MDD, partial responders to SSRI, as measured by the following measures: SAEs, DEAEs, C-SSRS, ASEX, CPFQ -To evaluate the effect of LY2216684 on depressive symptoms as an adjunctive treatment for MDD patients, partial responders to SSRI, measured by the change from baseline, using MADRS, HADS, CGI-S -To evaluate the effect of LY2216684 as an adjunctive treatment for MDD patients, partial responders to SSRI, in reducing fatigue symptoms associated with depression, measured using FAsD -To evaluate the effect of LY2216684 as an adjunctive treatment for MDD patients, partial responders to SSRI, measured by response and remission rates and time to response and remission -To evaluate the effect of LY2216684 as an adjunctive treatment for MDD patients, partial responders to SSRI, in reducing anxiety symptoms associated with depression, measured by HADS Anxiety Subscale score;Primary end point(s): The endpoint for Study Period II is defined as the last nonmissing observation obtained after Visit 2 through Visit 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Brazil, Chile, Denmark, Estonia, Latvia, Lithuania, Mexico, Netherlands, Portugal, Spain, United States
Contacts
Public ContactRoss Davidson
Lilly UK
Outcome results
None listed