Duloxetine versus Placebo in elderly patients with GAD

• Research type

  Research Study

• Full title

  A Phase 4, Parallel, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Duloxetine 30-120mg once daily (QD) with Placebo for the Acute Treatment of Generalized Anxiety Disorder in Elderly Patients (>65 years old)

• IRAS ID

  53729

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2009-010902-13

• Research summary

  Duloxetine is a marketed product currently under investigation to determine efficacy and safety in elderly patients (65 years or over) diagnosed with Generalised Anxiety Disorder (GAD). The drug is licensed to Eli Lilly and Company. Elderly patients who meet the criteria for GAD will be randomly assigned to receive duloxetine 30-120 mg once daily or matching placebo for a 10 week treatment period. Approximately 288 patients will be enrolled (144 to duloxetine and 144 to placebo) Study assessments include: Physical Examinations, Patient Questionnaires Blood/Urine tests. There is also an option to participate in a sub-study for DNA sampling and storage.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  10/H0106/50

• Date of REC Opinion

  23 Sep 2010

• REC opinion

  Further Information Favourable Opinion