A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Insomnia

Treatments: Drug: Esmirtazapine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00506389

P05707

176002 (Other Identifier)

Details and patient eligibility

About

The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.

Full 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. It has been reported that in patients with chronic insomnia lasting longer than six months, 50% had a past or current mental disorder. This raises the possibility that treatment of insomnia may reduce the risk for psychological conditions. This double-blind, placebo-controlled, parallel, randomized clinical trial is designed to assess the efficacy and safety of esmirtazapine in patients suffering from chronic primary insomnia.

Enrollment: 419 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented diagnosis of chronic primary insomnia

Exclusion criteria

• Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders
• Has significant medical or psychiatric illness as causing the sleep disorder
• Diagnosed with major depressive disorder
• Substance abuse within the past year
• Night worker or work on rotating shifts
• Has had serious head injury, stroke, epilepsy
• Has a history of bipolar disorder or family (immediate family) history of suicide
• Smokes more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory
• Drinks beverages containing more than 500 mg caffeine per day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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419 participants in 3 patient groups, including a placebo group

Esmirtazapine 3.0 mg

Experimental group

Description:

Participants took placebo tablets on Days -7 and -6, esmirtazapine 3.0 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.

Treatment:

Drug: Esmirtazapine

Esmirtazapine 4.5 mg

Experimental group

Description:

Participants took placebo tablets on Days -7 and -6, esmirtazapine 4.5 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.

Treatment:

Drug: Esmirtazapine

Placebo

Placebo Comparator group

Description:

Participants took placebo tablets on Days -7 and -6, placebo tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.

Treatment:

Drug: Placebo