ong-Term, Open-Label, Safety Study of LY2216684 12 to 18 mg Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder Who are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment
- Conditions
- Major depressive disorder (MDD)MedDRA version: 14.0Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders
- Registration Number
- EUCTR2010-020726-18-PT
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 excluded medications
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method