Zaleplon in HIV Patients With Depression

• 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: University of Pennsylvania
• Information provided by (Responsible Party): University of Pennsylvania

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).

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• 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
• Actual Study Start Date: April 3, 2014
• Actual Primary Completion Date: February 4, 2015
• Actual Study Completion Date: February 4, 2015

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03489304
• Other Study ID Numbers: 819083
• First Posted: April 5, 2018
• 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

• 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; 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