Clinical trial NCT03489304: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV/AIDS
Clinical Depression
Keywords: Insomnia
Zaleplon
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 6-week open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Measure at 6 weeks
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Measure at 6 weeks
measure: Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Measure at 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Mood & Anxiety Disorders Research and Treatment Program
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Matthew Kayser, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.