Efficacy Study of LY2422347 to Treat Insomnia

Lilly

Status and phase

Completed

Phase 2

Conditions

Sleep Initiation and Maintenance Disorders

Treatments

Drug: LY2422347

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00259311

H9U-MC-MDBD

9951

Details and patient eligibility

About

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).

Sex

All

Ages

24 to 75 years old

Volunteers

No Healthy Volunteers

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.