Clinical trial NCT00650871: A Study to Evaluate the Effects of GW679769 on Sleep and Cognitive Function in Subjects With Primary Insomnia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: sleep,
polysomnography.
GW679769,
primary insomnia,
cognitive function,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Wake time after sleep onset (WASO) derived from PSG recording
timeFrame: Night 1 and 2 of each treatment period (Approximately up to 31 Days)
Secondary outcomes:
measure: Mean total sleep time (TST) as objective PSG measures of sleep continuity
timeFrame: Night 1 and 2 of each treatment period (Approximately up to 31 days)
measure: Mean latency to persistent sleep (LPS) as objective PSG measures of sleep continuity
timeFrame: Night 1 and 2 of each treatment period (approximately 31 days)
measure: Mean wake during sleep (WDS) as objective PSG measures of sleep continuity
timeFrame: Night 1 and 2 of each treatment period (Approximately up to 31 days)
measure: Mean wake after sleep (WAS) as objective PSG measures of sleep continuity
timeFrame: Night 1 and 2 of each treatment period (Approximately up to 31 days)
measure: Mean number of 1 minute awakenings during sleep as objective PSG measures of sleep continuity
timeFrame: Night 1 and 2 of each treatment period (Approximately up to 31 days)
measure: Total Time in NREM Stage 1 and stage 2 as objective PSG measures of sleep structure
timeFrame: Night 1 and 2 of each treatment period (Approximately up to 31 days)
measure: Total Time in Slow Wave Sleep (SWS) as objective PSG measures of sleep structure
timeFrame: Night 1 and 2 of each treatment period (Approximately up to 31 days)
measure: Total Time in REM as objective PSG measures of sleep structure
timeFrame: Night 1 and 2 of each treatment period (Approximately up to 31 days)
measure: Latency to REM as objective PSG measures of sleep structure
timeFrame: Night 1 and 2 of each treatment period (Approximately up to 31 days)
measure: Total sleep time (TST) as parameter of subjective post-sleep questionnaire
timeFrame: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
measure: WASO as parameter of subjective post-sleep questionnaire
timeFrame: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
measure: Sleep onset latency (SOL) as parameter of subjective post-sleep questionnaire
timeFrame: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
measure: Number of awakenings as parameter of subjective post-sleep questionnaire
timeFrame: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
measure: Sleep quality (SQ) as parameter of subjective post-sleep questionnaire
timeFrame: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
measure: Digit symbol substitution test (DSST) as a measure of daytime cognitive function
timeFrame: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
measure: Mean Hopkins Verbal Learning Test-Revised (HVLT-R) score including total recall and delayed recall as a measure of Daytime Cognitive Function
timeFrame: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
measure: HVLT-R (Retention %) as a measure of daytime Cognitive Function
timeFrame: Night 1, Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
measure: HVLT-R (Recognition Discrimination Index [RDI]) as a measure of daytime Cognitive Function
timeFrame: Night 1, Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
measure: Leeds Sleep Evaluation Questionnaire as scales for sleepiness/alertness
timeFrame: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
measure: Stanford Sleepiness Scale as scales for sleepiness/alertness
timeFrame: Day 1 and 2 post PSG of each treatment period (Approximately up to 31 days)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: