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About
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine)
compared to placebo in elderly participants with chronic primary
insomnia. Primary efficacy variable is Wake time After Sleep
Onset (WASO), averaged over all in-treatment time points
and measured by polysomnography (PSG).
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, known as 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
TST (objective and subjective) and WASO, as compared to
placebo.
The current study is designed to assess the efficacy and safety
of Esmirtazapine in a double-blind, placebo-controlled, parallel,
randomized trial in elderly participants suffering from chronic
primary insomnia.
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Inclusion criteria
nature of the investigation have been explained to
them, before screening evaluations;
the investigator, study staff (including raters) and the
informed consent form, and possess the ability to
respond to questions, follow instructions and complete
questionnaires;
complete the LogPad questionnaires and have
completed the questionnaires at least 6 out of 7 days of
the week preceding randomization;
occurs between 2100 hours and 2400 hours, with no more variation
from these boundaries than 2 times/ week, with 5-8.5
hours in bed;
insomnia, defined as fulfillment of the Diagnostic and Statistical Manual of Mental Disorders IV - Text Revision (DSM-IV-TR) criteria
for primary insomnia (DSM-IV-TR 307.42) with a duration
of >= 1 month; fulfill the following PSG criteria on the
two screening/baseline PSG nights:
equal to 3 h and < 7 h),
(and each night greater than or equal to 30 min),
equal to 10 min).
Exclusion criteria
related breathing disorders Apnea-Hypopnea Index (AHI) greater than or equal
to 15), Periodic Leg Movements with Arousals Index (PLMAI)
greater than or equal to 10), restless leg syndrome,
narcolepsy, circadian sleep wake rhythm disorders,
Rapid Eye Movement (REM) behavioral disorder or any parasomnia;
psychiatric illness causing the sleep disturbances;
depression Major Depressive Disorder (MDD) or have been diagnosed and treated
for MDD within the last 2 years;
cognitive impairment, as defined by a score of less than
26 on the Mini-Mental State Examination;
chronic pain, hepatic, renal, metabolic or cardiac
disease;
or a history of (non-febrile) seizures;
screening, as judged by the investigator;
biochemistry values at screening, as judged by the
investigator;
addiction within the last year;
stimulants, alpha-2-antagonists, respiratory stimulants and decongestants);
Primary purpose
Allocation
Interventional model
Masking
538 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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