The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.
Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA34893 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
Per oral, once daily, during 8 weeks, followed by a two-week tapering period
Per oral doses, twice daily as capsules during 10 weeks
CA009
Mississauga, Ontario, Canada
Depressive symptoms as measured by the change from baseline in MADRS total score
Time frame: 8 weeks
HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination
Time frame: 8 weeks
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