NCT00807248

Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder

Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study of Escitalopram in Combination With Two Fixed Doses of Gaboxadol Compared to Escitalopram in Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 490 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of treatment in patients with Major Depressive Disorder

Detailed description

Subjects participating in this study will be respectively randomised (1:2:2:2) to receive either: * placebo or * escitalopram 20 mg/day or * escitalopram 20 mg/day in combination with gaboxadol 5 mg/day or * escitalopram 20 mg/day in combination with gaboxadol 10 mg/day

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Escitalopram placebo	Once daily before bedtime for 8 weeks
DRUG	Gaboxadol placebo	Once daily before bedtime for 8 weeks
DRUG	Escitalopram 20 mg	Once daily before bedtime for 8 weeks
DRUG	Gaboxadol 5 mg	Once daily before bedtime for 8 weeks
DRUG	Gaboxadol 10 mg	Once daily before bedtime for 8 weeks

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2008-12-11
• Last updated: 2012-12-17
• Results posted: 2011-08-11

Locations

22 sites across 2 countries: Austria, Russia