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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
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV/AIDS
Clinical Depression
Intervention Drug: Zaleplon
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zaleplon
Hide Arm/Group Description

Open-label zaleplon 5-10mg daily

Zaleplon: non-benzodiazepine hypnotic agent

Period Title: Overall Study
Started 20
Completed 16
Not Completed 4
Reason Not Completed
Lost to Follow-up             4
Arm/Group Title Zaleplon
Hide Arm/Group Description

Open-label zaleplon 5-10mg daily

Zaleplon: non-benzodiazepine hypnotic agent

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
49  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
6
  30.0%
Male
14
  70.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
16
  80.0%
White
4
  20.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Insomnia Severity Index (ISI)
Hide Description 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.
Time Frame Measure at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zaleplon
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Open-label zaleplon 5-10mg daily

Zaleplon: non-benzodiazepine hypnotic agent

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
11  (4.5)
2.Secondary Outcome
Title Epworth Sleepiness Scale (ESS)
Hide Description 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.
Time Frame Measure at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zaleplon
Hide Arm/Group Description:

Open-label zaleplon 5-10mg daily

Zaleplon: non-benzodiazepine hypnotic agent

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.5  (4.9)
3.Secondary Outcome
Title Quick Inventory of Depressive Symptomatology (QIDS)
Hide Description 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.
Time Frame Measure at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zaleplon
Hide Arm/Group Description:

Open-label zaleplon 5-10mg daily

Zaleplon: non-benzodiazepine hypnotic agent

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.7  (6.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zaleplon
Hide Arm/Group Description

Open-label zaleplon 5-10mg daily

Zaleplon: non-benzodiazepine hypnotic agent

All-Cause Mortality
Zaleplon
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zaleplon
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zaleplon
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Matthew Kayser
Organization: Perelman School of Medicine
Phone: 215 898 8298
EMail: kayser@pennmedicine.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03489304     History of Changes
Other Study ID Numbers: 819083
First Submitted: March 27, 2018
First Posted: April 5, 2018
Results First Submitted: August 22, 2018
Results First Posted: September 18, 2018
Last Update Posted: October 16, 2018