A Randomized, Double-Blind, Placebo-Controlled 8-Week Trial of the Efficacy and Tolerability of Multiple Doses of Lu AA21004 in Adults With Major Depressive Disorder

Aug 21, 2012The Journal of clinical psychiatry

An 8-week study testing different doses of Lu AA21004 for effectiveness and side effects in adults with major depression

AI simplified

Circadian Biology on OpenScience ↗PubMed ↗DOI ↗

Abstract

A total of 560 subjects were randomized in a trial of Lu AA21004, which showed a significant reduction in depression scores at the 10 mg dose compared to placebo.

Lu AA21004 10 mg resulted in a statistically significant reduction in the Hamilton Depression Rating Scale (HDRS-24) total score at week 8 compared to placebo (P < .001).
Improvements were observed in response and remission rates, as well as scores on the Clinical Global Impressions-Global Improvement scale and the Montgomery-Asberg Depression Rating Scale for all Lu AA21004 treatment groups versus placebo.
Subjects with a baseline anxiety score were also noted to have improved HDRS-24 total scores at week 8 across all treatment groups compared to placebo.
No significant differences in the Sheehan Disability Scale scores were found between any Lu AA21004 dose and placebo.
Common adverse events reported included nausea, headache, and dizziness, indicating that Lu AA21004 was well tolerated.

AI simplified

OBJECTIVE: Lu AA21004 is an investigational multimodal antidepressant. This randomized controlled trial evaluated the efficacy and tolerability of multiple doses of Lu AA21004 versus placebo in adults with major depressive disorder (MDD).

METHOD: Adults diagnosed with MDD (based on DSM-IV-TR criteria) with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 26 were randomly assigned (1:1:1:1) to receive Lu AA21004 1 mg, 5 mg, or 10 mg or placebo for 8 weeks (between August 2008 and August 2009). The primary endpoint was reduction in 24-Item Hamilton Depression Rating Scale (HDRS-24) total score after 8 weeks of treatment compared with placebo for Lu AA21004 10 mg. Additional outcomes included response and remission rates, Sheehan Disability Scale (SDS), Clinical Global Impressions-Global Improvement scale (CGI-I), MADRS total score, and HDRS-24 total score in subjects with baseline Hamilton Anxiety Rating Scale (HARS) score ≥ 20. Adverse events were assessed throughout the study.

RESULTS: A total of 560 subjects (mean age = 46.4 years) were randomized. There was a statistically significant reduction from baseline in HDRS-24 total score at week 8 for Lu AA21004 10 mg vs placebo (P < .001). There were improvements (nominal P values < .05 with no adjustment for multiplicity) in HDRS-24 total score, response and remission rates, CGI-I score, MADRS total score, and HDRS-24 total score in subjects with baseline HARS score ≥ 20 at week 8 for all Lu AA21004 treatment groups vs placebo. No significant differences were seen in SDS scores between any dose of Lu AA21004 and placebo. The most common adverse events were nausea, headache, and dizziness.

CONCLUSIONS: After 8 weeks of treatment with Lu AA21004 10 mg, there was a significant reduction in HDRS-24 total score compared with placebo in adults with MDD. Lu AA21004 was well tolerated in this study.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00735709.

A Randomized, Double-Blind, Placebo-Controlled 8-Week Trial of the Efficacy and Tolerability of Multiple Doses of Lu AA21004 in Adults With Major Depressive Disorder

Abstract

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the circadian biology brief

Abstract

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the circadian biology brief