Mental Disorders Clinical Trial
Official title:
A 6-Month, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Outpatient Trial, Investigating the Efficacy and Safety of Org 50081 in Adult Patients With Chronic Primary Insomnia
To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).
Insomnia is a common complaint or disorder throughout the world. About one third of the
population in the industrial countries reports difficulty initiating or maintaining sleep,
resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer
chronically from their complaints.
The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for
development in the treatment of insomnia. The first clinical trial with esmirtazapine was a
proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups
showed a statistically significant positive effect on TST (objective and subjective) and Wake
Time After Sleep Onset (WASO), as compared to placebo.
The current study is designed to assess the long-term efficacy and safety of esmirtazapine in
a double-blind, randomized, placebo-controlled, parallel group outpatient trial in
participants suffering from chronic primary insomnia. During the 6-month treatment period,
participants are randomly assigned to receive either esmirtazapine or placebo. Then, during
the 7-day discontinuation period, participants who received esmirtazapine in the 6-month
treatment period are randomly assigned to receive either esmirtazapine or placebo, while
participants who received placebo in the 6-month treatment period continue to receive
placebo.
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