Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs

• Status: Completed
• Trial end date: 1997-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurim Pharmaceuticals Ltd.
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Healthy male and female, aged ≥ 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.