Sleep Initiation and Maintenance Disorders
Conditions
Brief summary
The purpose of this study is to determine whether a compound known as LY2422347 is effective in treating people diagnosed with primary insomnia (difficulty sleeping with no other significant contributing factor, such as depression).
Interventions
DRUGLY2422347
DRUGplacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
24 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* must have been diagnosed with primary insomnia * must not be significantly overweight * must be able to visit the study doctor's office once every 2 weeks for 8 weeks and willing to use a handheld electronic device as a sleep diary every day * must be able to read and speak in English and be able to see well enough to use the handheld electronic device * the patient's answer to the question During the past month, how would you rate your sleep quality overall? must be either Very Bad or Fairly Bad
Exclusion criteria
* cannot have a clinically significant and/or uncontrolled condition or other significant ailment including restless leg syndrome (RLS) or periodic limb movement disorder (PLMD) * cannot have obstructive sleep apnea (OSA), or be considered by the study doctor to have probable OSA based upon patient history and physical examination * cannot be currently using antidepressants, antipsychotics, stimulants, antihistaminics, or other medications that are known to effect sleep * cannot have a current or previous major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder, social anxiety, or another psychotic disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy measure will be Wakening After Sleep Onset (WASO) | — |
Secondary
| Measure | Time frame |
|---|---|
| improvement of daily subjective sleep quality at endpoint | — |
| reduction in the Number of Awakenings or Arousal Index and increase of time spent in Slow Wave Sleep (SWS) and various other parameters at endpoint as measured with PSG | — |
| Various characteristics of sleep and daytime functioning assessed with biweekly self-report questionnaires at endpoint | — |
| Wake Time During Sleep (WTDS) and Wake Time After Sleep (WTAS) | — |
| Clinician Global Impression of Improvement (CGI-I) score at endpoint | — |
| improvement at endpoint on the biweekly subjective assessment of physical role functioning, emotional role functioning, vitality, social functioning, and mental health using the Short Form-12 | — |
| Safety and tolerability of LY2422347 compared with placebo | — |
| increase in subjective sleep efficiency at endpoint as assessed by the patient's daily diary | — |
Countries
United States
Outcome results
None listed