Overview

Zaleplon in HIV Patients With Depression

Status:
Completed
Trial end date:
2015-02-04
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pennsylvania
Treatments:
Zaleplon
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