Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)

• Status: Completed
• Trial end date: 2008-08-11
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Has signed written informed consent after the scope and nature of the investigation was explained to them

• Has difficulty falling asleep, maintaining sleep or has early morning awakenings

Exclusion Criteria:

• Significant medical or psychiatric illness causing sleep disturbances

• Has a history of bipolar disorder or family (immediate family) of suicide

• Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy

• Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year

• Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years

• Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.