Zaleplon in HIV Patients With Depression
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|ClinicalTrials.gov Identifier: NCT03489304|
Recruitment Status : Completed
First Posted : April 5, 2018
Results First Posted : September 18, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Clinical Depression||Drug: Zaleplon||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||6-week open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression|
|Masking:||None (Open Label)|
|Official Title:||A 6-week Open-Label Study of Treatment of Insomnia With Zaleplon in HIV Positive Patients With Comorbid Depression|
|Actual Study Start Date :||April 3, 2014|
|Actual Primary Completion Date :||February 4, 2015|
|Actual Study Completion Date :||February 4, 2015|
Open-label zaleplon 5-10mg daily
non-benzodiazepine hypnotic agent
- Insomnia Severity Index (ISI) [ Time Frame: Measure at 6 weeks ]The Insomnia Severity Index is a validated sleep scale that measures clinical insomnia severity. The total score ranges from 0-28 where higher values indicate increased severity of insomnia.
- Epworth Sleepiness Scale (ESS) [ Time Frame: Measure at 6 weeks ]The Epworth Sleepiness Scale (ESS) is a validated sleep scale that quantifies daytime sleepiness across eight domains. The total score ranges from 0-24 where higher values indicate greater daytime sleepiness.
- Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: Measure at 6 weeks ]The Quick Inventory of Depressive Symptomatology (QIDS) is a validated mood scale that quantifies depression symptoms. The total score ranges from 0-48, where higher values indicate greater depressive symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489304
|United States, Pennsylvania|
|Mood & Anxiety Disorders Research and Treatment Program|
|Philadelphia, Pennsylvania, United States, 29615|
|Principal Investigator:||Matthew Kayser, MD, PhD||University of Pennsylvania|