major depressive disorder MedDRA version: 13.1 Level: LLT Classification code 10012387 Term: Depression NOS System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: LY2216684
Product Code: LY2216684
Pharmaceutical Form: Tablet
INN or Proposed INN: LY2216684
Current Sponsor code: LY2216684
Concentration unit: mg milligram(s)
Concentration type: range
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical diagnosis of Major Depressive Disorder (MDD). Using a reliable method of birth control. Are taking an SSRI approved for MDD treatment within the patient's country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country. Have a partial response to SSRI treatment. Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment. Reliable and able to keep all scheduled appointments. Have had at least 1 previous episode of MDD prior to the current episode within the past 5 years. 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 1840 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 205
Exclusion criteria
Exclusion criteria: Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition other than major depression within 1 year of screening. Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias). Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder. Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSMIV-TR), not including caffeine and nicotine. Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol. Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, history of urinary hesitation or retention. Use of excluded concomitant or psychotropic medication other than SSRI. Have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment. Have a lifetime history of vagal nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or psychosurgery. Have received electroconvulsive therapy (ECT) in the past year Enrollment in a clinical study for an investigational drug. Serious or unstable medical condition. History of seizure disorders. Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or any time during the study. Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others. Are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Time to re-emergence of depressive symptoms ;Secondary Objective: Rate of re-emergence of depressive symptoms. Change in the Montgomery-Asberg Depression Rating Scale total score and individual items. Change in the Hospital Anxiety and Depression Scale depression and anxiety subscale scores. Change in the Clinical Global Impression of Severity scores. Change in the Fatigue Associated with Depression average score, experience subscale score, and impact subscale score. Change in the Sheehan Disability Scale items. Change in the EuroQol Questionnaire-5 Dimension index scores and visual analog scale global health-related quality of life score. Percentage of treatment emergent suicidal ideation and behaviors assessed by Columbia-Suicide Severity Rating Scale. Change in the Arizona Sexual Experiences Questionnaire. Change in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire scores. Safety assessment: treatment emergent adverse events, electrocardiograms, vital signs, laboratory measures, discontinuation rates.;Primary end point(s): Time to re-emergence of depressive symptoms during double-blind randomized withdrawal period, following open-label treatment;Timepoint(s) of evaluation of this end point: Randomization up to 44 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of participants with re-emergence of depressive symptoms. Change in the Montgomery-Asberg Depression Scale (MADRS) total score and individual item scores. Change in the Hospital anxiety and Depression Scale (HADS) depression and anxiety subscale scores. Change in the Clinical Global Impression of Severity (CGI-S) scores. Change in the Fatigue Associated with Depression (FAsD) average score, experience subscale score, and impact subscale score. Change in the Sheehan Disability Scale (SDS) items. Change in the EuroQoL Questionnaire-5 Dimensions (EQ-5D) index scores, visual analog scale. Number of participants with treatment emergent suicidal ideation and behaviors assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). Change in the Arizona Sexual Experiences (ASEX) Questionnaire. Change in the Massachusetts General Hospital Cognitive and Physical Functioning. Questionnaire (CPFQ) scores. Change in blood pressure. Change in pulse rate. ;Timepoint(s) of evaluation of this end point: Up to 18-20 weeks (if applicable); Randomization up to 44 weeks (if applicable) | — |
Countries
Argentina, Belgium, Brazil, Croatia, France, Germany, Greece, Italy, Korea, Republic of, Mexico, Romania, Russian Federation, Slovakia, Spain, Turkey, United States
Contacts
Public ContactClinical Trial Information Desk
Eli Lilly
Outcome results
None listed