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
- low spiritssadness10027946
- Registration Number
- NL-OMON36315
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Male and female, adult outpatients aged *18 years who meet DSM-IV-TR diagnostic criteria for MDD as determined by clinical assessment by the Mini-International Neuropsychiatric Interview (MINI) and confirmed by the physician and who have experienced a partial treatment response to a course of SSRI treatment for at least 6 weeks with at least the last 4 consecutive weeks at a stable, optimized dose prior to Visit 2. Patients must have a score *16 on the GRID 17-Item Hamilton Rating Scale for Depression (GRID HAMD17) total score at Visit 1 and Visit 2. Patients will be determined to be partial responders by history, by the opinion of the investigator. Patients will also be required to have a rating indicating *75% improvement for their current SSRI treatment using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) at Visit 1.
Exclusion criteria include any additional DSM-IV-TR Axis I condition other than major depression that was considered the primary diagnosis within 1 year of Visit 1; other primary Axis I anxiety 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); current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder; have a serious or unstable medical condition; have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow-angle glaucoma, or history of urinary hesitation or retention; use of excluded concomitant medication; serious ideation/risk for harm to self or others; and pregnancy or breastfeeding status.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to evaluate the long-term safety and<br /><br>tolerability of<br /><br>LY2216684 administered once daily (QD) in the adjunctive treatment with an SSRI<br /><br>for<br /><br>up to approximately 1 year in patients with MDD who are partial responders to<br /><br>their<br /><br>SSRI treatment.</p><br>
- Secondary Outcome Measures
Name Time Method