a safety study in participants with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: the primary objective of this study is to evaluate the long-term safety and tolerability of ly2216684 administered once daily (qd) in the adjunctive treatment with a selective serotonin reuptake inhibitor (ssri) for up to approximately 1 year in participants with major depressive disorder (mdd) who are partial responders to their ssri treatment.


Eligibility criteria:
inclusion criteria: * adults competent and able to give informed consent * women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control * participants who are being treated with one of the following selective serotonin reuptake inhibitors (ssris): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; for at least 6 weeks prior to investigational product dispensing with at least the last 4 weeks at a stable, optimized dose * drug and dosage should be within the labeling guidelines for the specific country * meet criteria for major depressive disorder (mdd), as defined by the diagnostic and statistical manual, fourth edition, text revision (dsm-iv-tr) criteria * meet criteria for partial response, as defined by investigator's opinion that participant has experienced a minimal clinically meaningful improvement with ssri * have a grid hamilton rating scale for depression (grid-hamd17) total score greater than or equal to 16 at screening * have less than or equal to 75 percent improvement on the current ssri at screening determined by the massachusetts general hospital antidepressant response questionnaire (mgh-atrq) * meet all other inclusion criteria per protocol exclusion criteria: * presence of another primary psychiatric illnesses: * have had or currently have any additional ongoing dsm-iv-tr axis i 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 dsm-iv-tr), not including caffeine and nicotine * have a dsm-iv-tr axis ii disorder that, in the judgment of the investigator, would interfere with compliance with protocol * unstable medical conditions that contraindicate the use of ly2216684 * have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled glaucoma, 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 of prior to enrollment * history of treatment resistant depression as shown by: * have had 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 participant has treatment-resistant depression * have a history of electroconvulsive therapy, transcranial magnetic stimulation, or psychosurgery within the last year * meet any other exclusion criteria per protocol