Clinical Trials

MainTitle

Zaleplon in HIV Patients With Depression

This study has been completed
Sponsor
University of Pennsylvania


Information provided by (Responsible Party)
University of Pennsylvania
ClinicalTrials.gov Identifier
NCT03489304

First received: March 27, 2018
Last updated: September 18, 2018
Last Verified: April 2018
History of Changes
Purpose

Purpose

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).

Condition Intervention Phase
HIV/AIDS
Clinical Depression

Drug : Zaleplon
Phase 2

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 6-week open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 6-week Open-Label Study of Treatment of Insomnia With Zaleplon in HIV Positive Patients With Comorbid Depression

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures

  • Insomnia Severity Index (ISI) [ Time Frame: 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.
Secondary Outcome Measures:
  • Epworth Sleepiness Scale (ESS) [ Time Frame: 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.
  • Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: 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.

Enrollment: 20
Study Start Date: April 3, 2014
Study Completion Date: February 4, 2015
Primary Completion Date: February 4, 2015 (Final data collection date for primary outcome measure)

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

non-benzodiazepine hypnotic agent

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. Male or female subjects aged 18-65 years with a diagnosis of asymptomatic seropositive HIV
    2. Principal diagnosis of Major Depressive Disorder or Dysthymic Disorder in accordance with DSM-IV criteria, and receiving pharmacologic treatment.
    3. 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
    4. 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))
    5. 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)
    6. Ability to understand the requirements of the study and provide informed consent


Exclusion Criteria:
    1. Significant chronic, systemic illness or significant neurologic disorder, including traumatic brain injury
    2. Clinically significant history of liver disease
    3. Psychiatrically unstable patients in the clinical judgment of the investigator as indicated by current acute suicidality, current homicidal thoughts, or current psychosis
    4. Lifetime history of schizophrenia, schizoaffective disorder, or any psychotic illness
    5. History of substance abuse or dependence over the past 6 months
    6. 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).
    7. Pregnant

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03489304

Locations

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

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator: Matthew Kayser, MD, PhD University of Pennsylvania
More Information

More Information


Responsible Party: University of Pennsylvania  
ClinicalTrials.gov Identifier: NCT03489304   History of Changes  
Other Study ID Numbers: 819083  
Study First Received: March 27, 2018  
Last Updated: September 18, 2018  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: No  

Keywords provided by University of Pennsylvania:

Insomnia
Zaleplon

Additional relevant MeSH terms:
Depression
Depressive Disorder
Zaleplon

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.