Primary Insomnia Clinical Trial
Official title:
Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.
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.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03461666 -
Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia
|
N/A | |
| Recruiting |
NCT02243501 -
Better Nights, Better Days for Typically Developing Children
|
N/A | |
| Completed |
NCT01636791 -
CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care
|
Phase 3 | |
| Completed |
NCT00770510 -
A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)
|
Phase 2/Phase 3 | |
| Completed |
NCT00520832 -
A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys
|
Phase 2 | |
| Recruiting |
NCT00415714 -
Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia
|
N/A | |
| Terminated |
NCT00420810 -
Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
|
Phase 3 | |
| Completed |
NCT00178048 -
Paroxetine in the Treatment of Chronic Primary Insomnia
|
Phase 4 | |
| Completed |
NCT01960452 -
A High Density EEG Comparison of Sleep Patterns in Insomnia
|
N/A | |
| Completed |
NCT01957111 -
Metabolomics of Insomnia-Related Hyperarousal
|
N/A | |
| Completed |
NCT01181232 -
A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients
|
Phase 4 | |
| Completed |
NCT00784875 -
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
|
Phase 2 | |
| Completed |
NCT00551148 -
A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
|
Phase 2 | |
| Completed |
NCT00397189 -
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
|
Phase 3 | |
| Completed |
NCT00352144 -
6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia
|
Phase 3 | |
| Completed |
NCT02290405 -
Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
|
||
| Completed |
NCT03314441 -
Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia
|
N/A | |
| Completed |
NCT00792298 -
Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006)
|
Phase 2 | |
| Completed |
NCT01021852 -
Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)
|
Phase 2 | |
| Completed |
NCT01719315 -
Neurophysiologic Correlates of Hypersomnia
|