A Study in Prevention of Re-emergence of Depression Symptoms

Status:	Completed
Conditions:	Depression, Major Depression Disorder (MDD)
Therapuetic Areas:	Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any
Updated:	2/4/2013
Start Date:	May 2011
End Date:	November 2013
Contact:	There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:	1-317-615-4559

LY2216684 Compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder

The primary purpose of this study is to assess whether LY2216684 (12 mg to 18 mg once daily)
is superior to placebo as adjunctive therapy to selective serotonin reuptake inhibitor
(SSRI) in patients with major depressive disorder (MDD) who were initially partial
responders to a SSRI in the prevention of re-emergence of depression symptoms in patients
with MDD who met remission criterion during open label treatment and randomization criteria
during a stabilization period. This trial consists of two distinct periods; an open label
treatment period, which consists of two parts, 8 weeks open label with movement to 10-12
weeks open label stabilization IF patients are in remission at end of 8 weeks (open label
for 18 to 20 weeks total) followed by a randomized blinded period for 24 to 26 weeks.

Inclusion Criteria:

- Outpatients with 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

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 a current or any 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 DSM-IV-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

- Have initiated or discontinued hormone therapy (including, birth control, thyroid
hormone) 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

- 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

- Meets criteria for treatment-resistant depression

We found this trial at

sites

Clinical Trial Facility in Burlington Wisconsin

Burlington, Wisconsin 53105

from

Burlington, WI