Phase 4
N=69
Characteristics of Sleep Patterns in Young Adults With and Without Insomnia
Sleep Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00177216 ↗Enrolled (actual)
69
Serious AEs
1.5%
Results posted
Mar 2016
Primary outcome: Primary: Change in Pittsburgh Sleep Quality Index — -0.86; -3.15; -3.32 difference score of PSQI total
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Zolpidem (Drug); Escitalopram (Drug); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pittsburgh Sleep Quality Index |
-0.86; -3.15; -3.32 | — |
| PRIMARY Change in Diary Sleep Efficiency |
3.20; 0.61; 4.87 | — |
| SECONDARY Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint |
0.43; 1.16; 0.32 | — |
Summary
This study will compare the symptoms, experiences, and laboratory sleep characteristics of young adults with and without insomnia.
Eligibility Criteria
Inclusion Criteria
- Physically healthy
- Meets DSM-IV criteria for primary insomnia
- For subjects interested in PET study only: right-handedness
Exclusion Criteria
- Currently taking antidepressants, antianxiety medications or medications for sleep disorders
- Currently experiencing symptoms of psychiatric disorders such as major depressive disorder, bipolar disorder, generalized anxiety disorder
- Significant or unstable acute or chronic medical conditions, such as seizure disorder, tumor, liver disease, active peptic ulcer disease, arthritis, irritable bowel disease
- Meets DSM-IV criteria for sleep apnea or periodic limb movement disorder
Data sourced from ClinicalTrials.gov (NCT00177216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.