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About
The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH 900265, MK-8265) to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.
Full 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.
The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for development in the treatment of insomnia. The first clinical trial with esmirtazapine was a proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups showed a statistically significant positive effect on Total Sleep Time (TST) (objective and subjective) and Wake Time After Sleep Onset (WASO), as compared to placebo.
The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.
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Inclusion criteria
are at least 65 years of age at screening;
sign written informed consent after the scope and nature of the investigation have been explained to them, before screening evaluations;
are able to speak, read and understand the language of the investigator, study staff (including raters) and the informed consent form, and possess the ability to respond to questions, follow instructions and complete questionnaires;
have demonstrated capability to independently complete the LogPad questionnaires in the week preceding randomization;
normal bedtime should be within the 21:00 - 01:00 hour range, with no more variation than 2 hours for 5 nights out of 7;
have a documented diagnosis of chronic primary insomnia, defined as fulfillment of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV-TR) criteria for primary insomnia [DSM-IV-TR 307.42]) with a duration of >= 1 month;
fulfill the following criteria based on medical or sleep history. Each of these criteria should be present for at least 3 nights per week for at least one month;
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259 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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