Zaleplon in HIV Patients With Depression

NCT03489304 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 819083
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV/AIDS; Clinical Depression

Keywords

Insomnia; Zaleplon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Epworth Sleepiness Scale (ESS)

  Measure at 6 weeks

• Quick Inventory of Depressive Symptomatology (QIDS)

  Measure at 6 weeks

Study Arms (1)

Zaleplon

OTHER

Open-label zaleplon 5-10mg daily

Drug: Zaleplon

Interventions

Zaleplon DRUG

non-benzodiazepine hypnotic agent

Zaleplon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Mood & Anxiety Disorders Research and Treatment Program

Philadelphia, Pennsylvania, 29615, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depressive Disorder, Major; Sleep Initiation and Maintenance Disorders

Interventions

zaleplon

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Dr. Matthew Kayser
• Organization: Perelman School of Medicine

kayser@pennmedicine.upenn.edu

215 898 8298

Study Officials

• Matthew Kayser, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 6-week open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 5, 2018
• Study Start: April 3, 2014
• Primary Completion: February 4, 2015
• Study Completion: February 4, 2015
• Last Updated: October 16, 2018
• Results First Posted: September 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)