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NCT00688025 Clinical Trial

Magnetoencephalographic (MEG) Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia

Insomnia Clinical Trial

Official title:
Magnetoencephalographic Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00688025
Other study ID # 07-033R
Secondary ID
Status Completed
Phase N/A
First received May 28, 2008
Last updated March 30, 2010
Start date May 2008
Est. completion date March 2010

Study information
Verified date March 2010
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The present protocol will utilize simultaneous recording of brain activity during attention and memory tasks in insomnia participants after ramelteon vs. zolpidem vs. placebo administration. The investigators hypothesize that amplitudes of associated with memory will be unchanged by ramelteon, whereas zolpidem will significantly reduce brain activity associated with stimulus processing as evidenced by abnormal reduction in the amplitude of specific brain regions relative to placebo.

Description:

The proposed research has two specific aims: 1) demonstrate that ramelteon has no effect on event related potential components that reflect basic sensory processes (P1 and N1), and will not impair attention and memory processes, whereas the benzodiazepine receptor agonist zolpidem will significantly reduce (relative to placebo) the amplitude of these event related potential components throughout the cerebral cortex and 2) show that ramelteon reduces the abnormal hyperarousal in insomnia as reflected through a reduction in the contingent negative variation component of the event related potential across frontal and parietal brain regions.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy individuals with no secondary condition to insomnia.

Exclusion Criteria:

- Healthy individuals with no insomnia.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Henry Ford Hospital Sleep Disorders & Research Center Detroit Michigan

Sponsors (2)
Lead Sponsor Collaborator
Henry Ford Health System Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

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