Clinical trial NCT00506389: A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
Official title: A Six-Week Double-Blind Randomized, Placebo-Controlled, Parallel Group, Efficacy and Safety, Sleep Lab Trial With Org 50081 in Patients With Chronic Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Keywords: Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic Dyssomnias, Sleep Disorders, Nervous System Diseases, Mental Disorders
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2007-07-25
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period
timeFrame: From Day 1 to Day 36
Secondary outcomes:
measure: Average Latency to Persistent Sleep (LPS) During the In-Treatment Period
timeFrame: From Day 1 to Day 36
measure: Average Subjective Total Sleep Time (TST) During the In-Treatment Period
timeFrame: From Day 1 to Day 36
Other outcomes:
Locations:
Study officials:
References:
citation: Ivgy-May N, Ruwe F, Krystal A, Roth T. Esmirtazapine in non-elderly adult patients with primary insomnia: efficacy and safety from a randomized, 6-week sleep laboratory trial. Sleep Med. 2015 Jul;16(7):838-44. doi: 10.1016/j.sleep.2015.04.001. Epub 2015 Apr 16.