A Study to Evaluate the Effects of GW679769 on Sleep and Cognitive Function in Subjects With Primary Insomnia
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 10/14/2017 |
| Start Date: | July 30, 2004 |
| End Date: | August 30, 2005 |
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of GW679769 (30mg and 90mg) on Sleep Continuity, PSG Sleep Recordings, Subjective Sleep Assessment, and Daytime Cognitive Function in Subjects With Primary Insomnia
A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects
participate in a clinical screening visit and a two-night PSG recording session in the sleep
laboratory. Eligible subjects then participate in three separate two-night PSG sessions in
which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior
to bedtime, one treatment for each session in a balanced order. Each treatment session is
separated by a two-week drug-free period and occur on the same day of the week. A safety
follow-up visit occurs 2 weeks after the last treatment session.
participate in a clinical screening visit and a two-night PSG recording session in the sleep
laboratory. Eligible subjects then participate in three separate two-night PSG sessions in
which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior
to bedtime, one treatment for each session in a balanced order. Each treatment session is
separated by a two-week drug-free period and occur on the same day of the week. A safety
follow-up visit occurs 2 weeks after the last treatment session.
Inclusion Criteria:
- Healthy male and female subjects with primary insomnia with normal EG may be eligible
for inclusion.
Exclusion Criteria:
- clinically significant physical or psychiatric illness or abnormal sleep patterns.
We found this trial at
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