Conditions: Insomnia Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders
Keywords: elderly randomized placebo controlled
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 538
Healthy volunteers: no

Brief summary:
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine)

compared to placebo in elderly participants with chronic primary

insomnia. Primary efficacy variable is Wake time After Sleep

Onset (WASO), averaged over all in-treatment time points

and measured by polysomnography (PSG).

Detailed description:
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, known as 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 WASO, as compared to

placebo.

The current study is designed to assess the efficacy and safety

of Esmirtazapine in a double-blind, placebo-controlled, parallel,

randomized trial in elderly participants suffering from chronic

primary insomnia.

Arms:
arm 1: one placebo tablet daily for 14 days, followed by one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days arm 2: one placebo tablet daily for 14 days, followed by one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days arm 3: one placebo tablet daily for 14 days, followed by one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days arm 4: one placebo tablet daily for 14 days, followed by one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days

Interventions: intervention 1: Esmirtazapine intervention 2: Placebo
Intervention descriptions: intervention 1: one tablet daily intervention 2: one tablet daily

Protocol document: