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

Phase 3

Completed

• Conditions: Insomnia
• Interventions: Drug: Esmirtazapine; Drug: Placebo

• Registration Number: NCT00506389
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-06-06
• Study First Submitted: 2007-07-23
• Study First Submitted QC: 2007-07-23
• Study First Posted: 2007-07-25
• Primary Completion: 2008-02-13
• Study Completion: 2008-02-13
• Disposition First Submitted: 2009-04-23
• Disposition First Submitted QC: 2009-09-30
• Disposition First Posted: 2009-10-02
• Results First Submitted: 2014-07-14
• Results First Submitted QC: 2014-07-14
• Results First Posted: 2014-08-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419

Inclusion Criteria

• Documented diagnosis of chronic primary insomnia

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esmirtazapine 3.0 mg	Esmirtazapine	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.
Esmirtazapine 4.5 mg	Esmirtazapine	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period	From Day 1 to Day 36	WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.

Secondary Outcome Measures

Name	Time	Method
Average Latency to Persistent Sleep (LPS) During the In-Treatment Period	From Day 1 to Day 36	LPS was defined as the time in minutes from lights out to the first 20 consecutive epochs scored as sleep as measured by PSG. LPS was calculated as the mean of Nights 1, 15, and 36.
Average Subjective Total Sleep Time (TST) During the In-Treatment Period	From Day 1 to Day 36	TST was defined as the total amount of time in minutes that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 6 week In-Treatment Period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were available was used in the analysis.