Conditions: Insomnia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 526
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

Detailed description:

Arms:
arm 1: Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 2: Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 3: Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 4: Placebo to esmirtazapine

Interventions: intervention 1: Esmirtazapine intervention 2: Placebo
Intervention descriptions: intervention 1: Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia \[USP\] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime. intervention 2: Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.

Protocol document: