Once daily oral LY2216684 adjunctive treatment for patients with MDD

• Research type

  Research Study

• Full title

  A randomized placebo-controlled, double-blind study of LY2216684 flexible-dose 12 to 18mg once daily as adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment.

• IRAS ID

  63860

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2010-021216-41

• Clinicaltrials.gov Identifier

  NCT01185340

• Research summary

  The investigational medicine LY2216684 is being tested as an adjunctive (additional) treatment for patients who have been diagnosed with Major Depressive Disorder (MDD).Patients who are enrolled into this study will have already been identified as partially responsive to a course of treatment with an SSRI treatment (Selective Serotonin Reuptake Inhibitor) for their MDD. Patients who are identified as suitable will be randomly assigned to receive either LY2216684 (12mg - 18mg flexible dose) once daily with their prescribed SSRI or matching Placebo for an 11 week treatment period.Approximately 1100 patients will be enrolled in the study globally. Patients will be male and female and must be aged over 18 years. Study assessments will include: Physical examinations, patient questionnaires and blood and urine tests. Patients will also have a blood sample taken for genetic testing which may help with this and future research.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  11/EM/0105

• Date of REC Opinion

  7 Jun 2011

• REC opinion

  Further Information Favourable Opinion