A Study in Prevention of Re-emergence of Depression Symptoms

• Conditions: major depressive disorder; MedDRA version: 14.1Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-024632-42-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-20
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2045

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: 0
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified