drugset / Trial / NCT00807248

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

NCT00807248 ↗

Phase 2 Completed 490 enrolled H. Lundbeck A/S
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2008-11
Primary completion
2009-12
Completion
2010-02

Outcome

Missed primary endpoint

registry Escitalopram 20 mg and Placebo (Orally, Once Daily) vs Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily); p = 0.6405 NCT00807248 ↗

registry Escitalopram 20 mg and Placebo (Orally, Once Daily) vs Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily); p = 0.6227 NCT00807248 ↗

paper There was no statistically significant difference in the mean change from baseline in MADRS total score between the 20 mg escitalopram+10 mg gaboxadol group PMID 22008735 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Escitalopram Small molecule 20 mg —
Subject Gaboxadol Unknown 5 mg —
Subject Gaboxadol Unknown 10 mg —