Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Zaleplon in HIV Patients With Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03489304
Recruitment Status : Completed
First Posted : April 5, 2018
Results First Posted : September 18, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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).

Condition or disease Intervention/treatment Phase
HIV/AIDS Clinical Depression Drug: Zaleplon Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Actual Study Start Date : April 3, 2014
Actual Primary Completion Date : February 4, 2015
Actual Study Completion Date : February 4, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Zaleplon

Arm Intervention/treatment
Zaleplon
Open-label zaleplon 5-10mg daily
Drug: Zaleplon
non-benzodiazepine hypnotic agent




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489304


Locations
Layout table for location information
United States, Pennsylvania
Mood & Anxiety Disorders Research and Treatment Program
Philadelphia, Pennsylvania, United States, 29615
Sponsors and Collaborators
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Matthew Kayser, MD, PhD University of Pennsylvania

Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03489304     History of Changes
Other Study ID Numbers: 819083
First Posted: April 5, 2018    Key Record Dates
Results First Posted: September 18, 2018
Last Update Posted: October 16, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Zaleplon
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action