NCT03489304

Zaleplon in HIV Patients With Depression

Completed Phase 2 Results posted Last updated 16 October 2018

What this trial tests

Phase 2 trial testing Zaleplon in HIV/AIDS in 20 participants. Completed in 4 February 2015.

Timeline

3 April 2014

Primary endpoint
4 February 2015

4 February 2015

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	3 April 2014
Primary completion	4 February 2015
Estimated completion	4 February 2015
Sites	1 location across United States

Drugs / interventions tested

• Zaleplon (ZALEPLON) — full drug profile →

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Clinical Depression — all drugs for Clinical Depression →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 65, any sex, with HIV/AIDS or Clinical Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Insomnia Severity Index (ISI) Primary · 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.

Group	Value	95% CI
Zaleplon	11	± 4.5

Epworth Sleepiness Scale (ESS) Secondary · 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.

Group	Value	95% CI
Zaleplon	6.5	± 4.9

Quick Inventory of Depressive Symptomatology (QIDS) Secondary · 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.

Group	Value	95% CI
Zaleplon	8.7	± 6.3

Sponsor's own description

In HIV positive patients with sleep onset insomnia and receiving pharmacologic treatment for comorbid depression, the proposed study aims to evaluate the impact of zaleplon on sleep measures determined by insomnia severity index (ISI) and Epworth sleepiness scale (ESS).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatment of Insomnia with Zaleplon in HIV+ Significantly Improves Sleep and Depression.
   Goldschmied JR, Sengupta A, Sharma A, Taylor L, et al · · 2021 · cited 3× · PMID 34421144 · DOI 10.64719/pb.4409