A Randomized, Double-Blind Comparison of LY2216684and Placebo and Long Term Treatment with LY2216684in Adult Patients with Major Depressive Disorder

Conditions: Patients with Major Depressive Disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR
APA2004),
MedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOS

Registration Number: EUCTR2008-002857-18-FI

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 478

Inclusion Criteria

Adult men or women at least 18 to 65 years of age at informed
consent, who provide informed consent by signing the appropriate
ICDs. Patients must be competent and able to give their own
informed consent.
[2] Meet criteria for MDD as defined by DSM-IV-TR criteria without
psychotic features, as determined by clinical assessment and
confirmed by the MINI at Visit 1. Have had at least one other major
depressive episode prior to the current episode.
[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
enrollment 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.
[4] Have a GRID-HAMD17 total score =18 at Visit 1 and Visit 2.
[5] Have a CGI-Severity score =4 at Visit 1 and Visit 2.
[6] Have an education level and a degree of understanding such that the
patient can communicate with the site study personnel.
[7] 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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
* Have previously completed or withdrawn from this study or any other
study investigating LY2216684.
* 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.
*Have had any anxiety disorder preceding the onset of depression that
was considered a primary diagnosis within the past year (including
panic disorder, obsessive-compulsive disorder, posttraumatic stress
disorder, generalized anxiety disorder, and social phobia, but
excluding specific phobias).
*Have an Axis II disorder which, in the judgment of the investigator,
would interfere with compliance with the study protocol.
*Have a current or previous diagnosis of Bipolar I or II Disorder,
psychotic depression, schizophrenia, or other psychotic disorder
*Women who are pregnant or breast-feeding.
*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.
*Patients who, in the opinion of the investigator, are judged to be at
serious risk for harm to self or others.
*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
urinary hesitancy or retention.
*Have received treatment with a monoamine oxidase inhibitor within
14 days prior to Visit 1 or have a potential need to use a monoamine
oxidase inhibitor within 14 days after discontinuation from the study.
*Have received treatment with fluoxetine within 30 days prior to
Visit 2.
*Have a history of electroconvulsive therapy (ECT), transcranial
magnetic stimulation (TMS), or psychosurgery within the last year
*Have a history of any seizure disorder (other than febrile seizures).
*Require psychotropic medication other than sedative/hypnotic
medication for sleep as specified in the protocol.
*Have a thyroid stimulating hormone (TSH) level outside the laboratory
established reference range. Patients previously diagnosed with
hyperthyroidism or hypothyroidism who have been treated with a
stable dose of thyroid supplement for at least the past 3 months, and
who are clinically and chemically euthyroid, will be allowed to
participate in the study.
*Have initiated or discontinued hormone therapy within the previous
3 months prior to enrollment.