Primary Insomnia
Conditions
Brief summary
The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.
Interventions
DRUGPD 0200390
oral 15 mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
OTHERPlacebo
oral placebo mg dose on 2 consecutive nights. This is one of 5 treatment doses administered one week apart for 5 consecutive weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
3 month history of Primary Insomnia (DSM-IV criteria) Self report sleep criteria for at least 3 nights per week in past month; sWASO (subjective wake after sleep onset) equal or greater than 60 mins sLSO (subjective latency to sleep onset) equal or greater than 45 minutes TST less than or equal to 6.5 hrs Maintain normal daytime-awake, nighttime-sleep schedule PSG sleep criteria of mean WASO equal or greater than 60 mins calculated on 2 PSG screening nights TST between 3 to 7 hrs on 2 PSG screening nights Mean LPS (latency to persistent sleep) equal or greater than 20 mins calculated on 2 PSG screening nights
Exclusion criteria
Comorbid psychiatric disease or disorders History or presence of breathing-related disorders Multivariable Apnea risk index (MAP) equal or greater than 0.5 at screening History or presence of medical or neurological condition interfering with sleep Current use of know psychotropic effect medications Excessive caffeine use Use of alcohol as a sleep aid or more than 2 standard drinks/day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-response relationship of PD 200390 on wake after sleep onset (WASO) in subjects with primary insomnia as determined by Polysomnography | weekly |
Secondary
| Measure | Time frame |
|---|---|
| Subjective assessments of wake after sleep onset (sWASO), latency to sleep onset (LSO), number of awakenings after sleep onset (sNAASO), total sleep time (TST), and sleep quality via questionnaire. | weekly |
| Subjective assessment of sleep with Leeds Sleep Evaluation Questionnaire-LSEQ. | weekly |
| PSG efficacy assessments including number of awakenings after sleep onset (NAASO), number of arousals, total sleep time (TST), sleep efficiency (SE), total wake time (TWT) | weekly |
| Latency to persistent sleep (LPS) as determined by Polysomnography | weekly |
Countries
United States
Outcome results
None listed