Status:
COMPLETED
A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Sleep Initiation and Maintenance Disorders
Mental Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 v...
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-re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 4 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2009
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00631657
Start Date
March 4 2008
End Date
November 19 2009
Last Update
October 2 2018
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