Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs

Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00816673

Acronym

Neu I

Enrollment

Registered

2009-01-05

Start date

1996-09-30

Completion date

1997-09-30

Last updated

2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia

Keywords

Insomnia, Primary insomnia, sleep latency, non restorative sleep, sleep quality, Double-Blind, Placebo Controlled, Parallel-Group, Sleep Laboratory Study

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).

Interventions

DRUGplacebo Circadin

Placebo tabs of Prolonged release melatonin

DRUGCircadin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 70 Years

Healthy volunteers

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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026