At a glance
ClinicalIndex Comparison Record- ✓Physically healthy
- ✓Meets DSM-IV criteria for primary insomnia
- ✓Right-handedness required only for subjects interested in PET study
- ✕Currently taking antidepressants, antianxiety medications, or sleep disorder medications
- ✕Active symptoms of major depressive disorder, bipolar disorder, or generalized anxiety disorder
- ✕Significant or unstable acute or chronic medical conditions (seizure disorder, tumor, liver disease, peptic ulcer disease, arthritis, irritable bowel disease)
- ✕Sleep apnea or periodic limb movement disorder (DSM-IV criteria)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Psychobiology and Treatment Response in Primary Insomnia
In Brief
A Phase 4 clinical trial evaluating Zolpidem, Escitalopram, and 1 other intervention for Sleep Disorders. Completed, enrolled 69 participants across 1 site.
Detailed Summary
This study will compare the symptoms, experiences, and laboratory sleep characteristics of young adults with and without insomnia.
Study Details
Timeline
Interventions
The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or \>). The dose was decreased to 5 mg if side effects occurred.
The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.