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

• Status: Completed
• Trial end date: 2008-02-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Parexel
• Treatments: Mirtazapine

Criteria

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