Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs

NCT ID: NCT00816673

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-09-30
• Study Completion Date: 1997-09-30

Brief 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.

Detailed Description

Circadin® is a newly developed slow release galenic formulation of melatonin, producing overall levels of melatonin comparable to those observed in a control population, when administered to patients with deficiency in melatonin; thus it deserves more clinical and paraclinical investigations for establishing efficacy in inducing and maintaining sleep and for safety. Since, on the one hand, the endogenous substance melatonin has beneficial effects on sleep in man and, on the other hand, there is a decrease in melatonin secretion in elderly people, substitution therapy in elderly insomniacs would be a desirable therapy.

The aim of this placebo controlled study was 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. Sleep was assessed by means of polysomnography (hypnographic results), all-night sleep EEG spectral analysis (functional and quantitative results of sleep EEG), actimetry (SomnitorTM), wake EEG and sleep/wake quality questionnaires. Vigilance and cognitive skills were assessed by means of psychomotor and neurocognitive tests derived from the Leeds psychomotor test battery (vigilance and arousal) and TEA battery (attention).

Conditions

Primary Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

placebo

Group Type: PLACEBO_COMPARATOR

placebo Circadin

Intervention Type: DRUG

Placebo tabs of Prolonged release melatonin

Circadin

Group Type: EXPERIMENTAL

Circadin

Intervention Type: DRUG

prolonged release melatonin 2 mg taken daily 2 hours before bed-time for 3 weeks

Interventions

placebo Circadin

Placebo tabs of Prolonged release melatonin

Intervention Type: DRUG

Circadin

prolonged release melatonin 2 mg taken daily 2 hours before bed-time for 3 weeks

Intervention Type: DRUG

Other Intervention Names

ATC code: N05CH01

Eligibility 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurim Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Neurim Pharmaceuticals Ltd.

Principal Investigators

Jean Paul MACHER, MD

Role: PRINCIPAL_INVESTIGATOR

Forenap

Locations

FORENAP

Centre Hospitalier de Rouffach, , France

Countries

France

Other Identifiers

Neurim I

Identifier Type: -

Identifier Source: org_study_id