Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs (NCT00816673) | Clinical Trial Compass
CompletedPhase 2
Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs
France40 participantsStarted 1996-09
Plain-language summary
The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (CircadinĀ®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.
Who can participate
Age range55 Years ā 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male and female, aged ā„ 55 years, suffering from primary insomnia according to DSM-IV criteria (307.42)
Exclusion Criteria:
* According to DSM-IV, subjects belonging to the following groups are excluded: 780.59; 307.45; 307.47; 780.xx (Appendix 2);
* Use of benzodiazepines or other hypnotics during the preceding 1 month with a frequency of more than 2 times a week and lasting more than 2 weeks;
* Severe neurological, psychiatric or sleep disorders;
* Other serious diseases;
* Taking more than 1/2 l of alcohol, more than 3 cups of coffee or more than 10 cigarettes per day .
* Subjects who need beta blockers as a treatment.