A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)

• Status: Completed
• Trial end date: 2009-11-19
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081, SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia. Primary efficacy variable is Total Sleep Time (TST).

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

Details

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

Criteria

Inclusion Criteria:

• are at least 18 and less than 65 years;

• sign written informed consent after the scope and nature of the investigation have been explained;

• have shown capability to complete the LogPad questionnaires;

• have difficulty falling asleep, maintaining sleep or have early morning awakening;

Exclusion Criteria:

• Significant medical or psychiatric illness causing sleep disturbances.

• Have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide.

• Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy.

• Significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year.

• Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have been treated for MDD in the last 2 years.

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

• Are night workers or rotating shift workers or plan to travel through more than 3 time-zones.

• Routinely nap during the day.

• Have a Body Mass Index (BMI) of 36 or more.