Trial Outcomes & Findings for Zaleplon in HIV Patients With Depression (NCT NCT03489304)

NCT ID: NCT03489304

Last Updated: 2018-10-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Measure at 6 weeks
• Results posted on: 2018-10-16

Participant Flow

Participant milestones

Measure	Zaleplon Open-label zaleplon 5-10mg daily Zaleplon: non-benzodiazepine hypnotic agent
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Zaleplon Open-label zaleplon 5-10mg daily Zaleplon: non-benzodiazepine hypnotic agent
Overall Study Lost to Follow-up	4

Baseline Characteristics

Zaleplon in HIV Patients With Depression

Baseline characteristics by cohort

Measure	Zaleplon n=20 Participants Open-label zaleplon 5-10mg daily Zaleplon: non-benzodiazepine hypnotic agent
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	49 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Zaleplon n=16 Participants Open-label zaleplon 5-10mg daily Zaleplon: non-benzodiazepine hypnotic agent
Insomnia Severity Index (ISI)	11 score on a scale Standard Deviation 4.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Zaleplon n=16 Participants Open-label zaleplon 5-10mg daily Zaleplon: non-benzodiazepine hypnotic agent
Epworth Sleepiness Scale (ESS)	6.5 score on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Zaleplon n=16 Participants Open-label zaleplon 5-10mg daily Zaleplon: non-benzodiazepine hypnotic agent
Quick Inventory of Depressive Symptomatology (QIDS)	8.7 score on a scale Standard Deviation 6.3

Adverse Events

Zaleplon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Matthew Kayser

Perelman School of Medicine

Phone: 215 898 8298

Email: kayser@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place