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Zaleplon in HIV Patients With Depression

Primary Purpose

HIV/AIDS, Clinical Depression

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Zaleplon

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring Insomnia, Zaleplon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Mood & Anxiety Disorders Research and Treatment Program

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Zaleplon

Arm Description

Open-label zaleplon 5-10mg daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03489304

First Posted

March 27, 2018

Last Updated

September 18, 2018

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT03489304

Brief Title

Zaleplon in HIV Patients With Depression

Official Title

A 6-week Open-Label Study of Treatment of Insomnia With Zaleplon in HIV Positive Patients With Comorbid Depression

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

April 3, 2014 (Actual)

Primary Completion Date

February 4, 2015 (Actual)

Study Completion Date

February 4, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV/AIDS, Clinical Depression

Keywords

Insomnia, Zaleplon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

6-week open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zaleplon

Arm Type

Other

Arm Description

Open-label zaleplon 5-10mg daily

Intervention Type

Drug

Intervention Name(s)

Zaleplon

Intervention Description

non-benzodiazepine hypnotic agent

Primary Outcome Measure Information:

Title

Insomnia Severity Index (ISI)

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

Secondary Outcome Measure Information:

Title

Epworth Sleepiness Scale (ESS)

Description

Time Frame

Measure at 6 weeks

Title

Quick Inventory of Depressive Symptomatology (QIDS)

Description

Time Frame

Measure at 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew Kayser, MD, PhD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mood & Anxiety Disorders Research and Treatment Program

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

29615

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34421144

Citation

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.

Results Reference

derived

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Zaleplon in HIV Patients With Depression

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