CompletedNCT03489304Updated Oct 16, 2018Results posted

Zaleplon in HIV Patients With Depression

A Phase 2 interventional study of Zaleplon in HIV/AIDS and Clinical Depression, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-16.

Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years to 65 Years
Sex: All

Study summary

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).

Read the detailed description

An estimated >50% of HIV positive individuals report insomnia. Insomnia and other sleep disturbances negatively impact outcomes in this population by contributing to metabolic dysfunction, reducing quality of life, and impairing psychosocial functioning. Additionally, in HIV depressed populations, insomnia may hinder remission from clinical depression. To date, there have been no pharmacotherapeutic studies treating insomnia in this population, emphasizing the need to determine whether known hypnotic medications work as effectively in HIV positive patients, including those with comorbid depression. Non-benzodiazepine hypnotics represent an attractive pharmacotherapy for treatment of insomnia in a depressed population, as there are reduced side effects and abuse potential compared to classical benzodiazepines. Consequently, an open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression warrants further study.

Conditions studied

HIV/AIDS
Clinical Depression

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Keywords

Insomnia
Zaleplon

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female subjects aged 18-65 years with a diagnosis of asymptomatic seropositive HIV
Principal diagnosis of Major Depressive Disorder or Dysthymic Disorder in accordance with DSM-IV criteria, and receiving pharmacologic treatment.
Subject has obtained some subjective benefit from current antidepressant therapy and is agreeable to remain on the same medication for the course of this study
Current symptoms of insomnia as determined by a total score of at least 2 on items 4, 5, and 6 of the HAM-D, and specific complaint of sleep onset insomnia (sleep onset latency of at least 1 hour, 3 or more times per week))
Free of sleep medication for at least 2 weeks prior to enrollment (we will not enroll any patients who might require weaning off of sedative hypnotic medications in order to be eligible for the study)
Ability to understand the requirements of the study and provide informed consent

Exclusion criteria

Exclusion Criteria:

Significant chronic, systemic illness or significant neurologic disorder, including traumatic brain injury
Clinically significant history of liver disease
Psychiatrically unstable patients in the clinical judgment of the investigator as indicated by current acute suicidality, current homicidal thoughts, or current psychosis
Lifetime history of schizophrenia, schizoaffective disorder, or any psychotic illness
History of substance abuse or dependence over the past 6 months
Currently taking medication to assist with sleep (e.g., Ambien/Zolpidem,Dalmane/Flurazepam, Doral/Quazepam, Halcion/Triazolam, Lunesta/Eszopiclone, Prosom/Estazolam, Restoril/Temazepam, Rozerem/Ramelteon, Sonata/Zaleplon, Melatonin, Unisom, Benadryl).
Pregnant

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Other
Zaleplon
Open-label zaleplon 5-10mg daily
Drug: Zaleplon

Interventions

DrugZaleplon
non-benzodiazepine hypnotic agent

What researchers measure

Primary outcomes

Insomnia Severity Index (ISI)
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

Secondary outcomes

Epworth Sleepiness Scale (ESS)
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
Quick Inventory of Depressive Symptomatology (QIDS)
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

Results

Posted Sep 18, 2018

Participant flow

Participant flow — Overall Study
Milestone	Zaleplon
Started	20
Completed	16
Not completed	4
Withdrew: Lost to follow-up	4

Outcome measures

PrimaryInsomnia Severity Index (ISI)

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
Reported as:: Mean · score on a scale

Insomnia Severity Index (ISI)
score on a scale	Zaleplon
Insomnia Severity Index (ISI)	11 ± 4.5

SecondaryEpworth Sleepiness Scale (ESS)

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
Reported as:: Mean · score on a scale

Epworth Sleepiness Scale (ESS)
score on a scale	Zaleplon
Epworth Sleepiness Scale (ESS)	6.5 ± 4.9

SecondaryQuick Inventory of Depressive Symptomatology (QIDS)

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
Reported as:: Mean · score on a scale

Quick Inventory of Depressive Symptomatology (QIDS)
score on a scale	Zaleplon
Quick Inventory of Depressive Symptomatology (QIDS)	8.7 ± 6.3

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Zaleplon	—	0/20 (0%)	0/20 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Zaleplon
<=18 years	0
Between 18 and 65 years	20
>=65 years	0

Age, Continuous
Age, Continuous(years)	Zaleplon
Mean	49 ± 9

Sex: Female, Male
Sex: Female, Male(Participants)	Zaleplon
Female	6
Male	14

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Zaleplon
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	16
White	4
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(Participants)	Zaleplon
United States	20

Study locations

1 site

Mood & Anxiety Disorders Research and Treatment Program
Philadelphia, Pennsylvania 29615, United States

References and documents

Publications

Goldschmied JR, Sengupta A, Sharma A, Taylor L, Morales KH, Thase ME, Thase ME, Weljie A, Kayser MS. Treatment of Insomnia with Zaleplon in HIV+ Significantly Improves Sleep and Depression. Psychopharmacol Bull. 2021 Jun 1;51(3):50-64. PubMed 34421144 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03489304
Lead sponsor: University of Pennsylvania
Responsible party: Sponsor
First posted: Apr 5, 2018
Start date: Apr 3, 2014
Primary completion: Feb 4, 2015
Completion: Feb 4, 2015
Results posted: Sep 18, 2018
Last update: Oct 16, 2018

Study contacts

Matthew Kayser, MD, PhD

principal investigator · University of Pennsylvania

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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