Combining escitalopram with gaboxadol provides no additional benefit in the treatment of patients with severe major depressive disorder.

Abstract

The aim of this proof-of-concept study was to compare the efficacy of escitalopram (20 mg/d) in combination with fixed doses of gaboxadol to escitalopram (20 mg) in the treatment of patients with severe major depressive disorder (MDD). Adult patients were randomized to 8 wk of double-blind treatment with fixed doses of placebo (n=71), escitalopram (20 mg, n=140), escitalopram (20 mg)+gaboxadol (5 mg) (n=139), or escitalopram (20 mg)+gaboxadol (10 mg) (n=140). The pre-defined primary analysis of efficacy was an analysis of covariance (ANCOVA) of change from baseline to endpoint (week 8) in Montgomery-Åsberg Depression Rating Scale (MADRS) total score using last observation carried forward (LOCF). 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 and the 20 mg escitalopram group [difference=-0.45 MADRS points (95% CI -2.5 to 1.6, p=0.6619, full analysis set (FAS), LOCF, ANCOVA)] at week 8. The mean treatment differences to placebo at week 8 were -5.6 (95% CI -8.0 to -3.1, p<0.0001) (20 mg escitalopram), -5.1 (95% CI -7.5 to -2.7, p<0.0001) (20 mg escitalopram+5 mg gaboxadol), and -6.0 (95% CI -8.4 to -3.6, p<0.0001) (20 mg escitalopram+10 mg gaboxadol). The most common adverse events reported in the active treatment groups for which the incidence was higher than that in the placebo group, comprised nausea, anxiety and insomnia. There were no clinically relevant efficacy differences between a combination of escitalopram and gaboxadol compared to escitalopram alone in the treatment of severe MDD. All active treatment groups were superior in efficacy to placebo and were well tolerated.

• Authors: Siegfried Kasper, Bjarke Ebert, Klaus Larsen, Brigitte Tonnoir
• Journal: The international journal of neuropsychopharmacology (Int J Neuropsychopharmacol) Vol. 15 Issue 6 Pg. 715-25 (Jul 2012) ISSN: 1469-5111 [Electronic] England
• PMID: 22008735 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics
• Antidepressive Agents, Second-Generation
• Isoxazoles
• Citalopram
• gaboxadol

Topics

• Adolescent
• Adult
• Aged
• Analgesics (therapeutic use)
• Analysis of Variance
• Antidepressive Agents, Second-Generation (therapeutic use)
• Citalopram (therapeutic use)
• Depressive Disorder, Major (drug therapy)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Humans
• International Cooperation
• Isoxazoles (therapeutic use)
• Male
• Middle Aged
• Psychiatric Status Rating Scales
• Treatment Outcome
• Young Adult