Nonrestorative Sleep
Conditions
Brief summary
In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.
Interventions
DRUGPD 0200390
oral 15 mg daily dose, 3 capsules per dose during a six week treatment period.
DRUGPlacebo
oral placebo daily dose, 3 capsules per dose during a six week treatment period.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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
* Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening * Self-report wake after sleep onset \<45 mins for past 3 mos; self-report latency to sleep onset \<20 mins for past 3 mos * PSG (Polysomnography) sleep criteria of wake after sleep onset \< 45 mins; Latency to persistent sleep \<20 mins.
Exclusion criteria
* MAP (Multivariable Apnea Risk index) index \> or = 0.5 at screening * BMI = or \> 32 kg/m2 * History or presence of breathing related disorders * PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index \> 10/hr; or period limb movement with arousal index \> 10/hr.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly) | Weekly |
Secondary
| Measure | Time frame |
|---|---|
| Total score of the Daily Restorative Sleep Questionnaire | Daily |
| Total score of the Multidimensional Assessment of Fatigue (MAF) | Weekly |
| Total score of the Sheehan Disability Scale to measure functional impairment | Weekly |
| Measure of health status using the Medical Outcomes Study Short Form-36 (SF-36v2-Acute) | Weekly |
| Measure sleep and early morning behavior during treatment using the Leeds Sleep Evaluation Questionnaire | Weeky |
| Total score of the Endicott Work Productivity Scale (EWPS) measuring work productivity. | Weekly |
| Disease severity and change using the Clinical Global Impression of Severity (CGI-S) as rated by the Clinician. | Weekly |
| Disease change (patient rated) measure using the Patient Global Impression of Change (PGIC). | Weekly |
| Total mood disturbance score using the Profile of Mood State-Short Form Questionnaire (POMS-SF) | Weekly |
Countries
Canada, United States
Outcome results
None listed