Zaleplon in HIV Patients With Depression

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS, Clinical Depression

Intervention / Treatment
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* Drug: Zaleplon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 6-week open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Zaleplon<br>Open-label zaleplon 5-10mg daily | Drug: Zaleplon<br>* non-benzodiazepine hypnotic agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measure at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measure at 6 weeks | 
| 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. | Measure at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Zaleplon