Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans
Status:
Terminated
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
This is a pilot comparative effectiveness study designed to determine whether trazodone is as
effective as quetiapine for treatment of insomnia in veterans with a history of addiction and
mental health issues. The study will have two concurrent phases (parts); first an
acceptability determination phase, to determine whether and why (or why not) veterans already
taking quetiapine are willing to try an alternative to quetiapine for sleep; and second, a
randomized trial phase which will test whether staying on quetiapine has any advantage over
switching to trazodone. The purpose of the first phase will be a) to document the proportions
of patients and physicians who are willing to agree to such a switch, b) to characterize
sociodemographic and clinical characteristics of potentially eligible subjects associated
with a willingness to switch from quetiapine to trazodone and c) to record the reasons given
why patients and their prescribers are (or are not) willing to accept a switch from
quetiapine to trazodone. It will also function to provide some educational background to
patients and a reminder to providers about the potential severe side-effects of quetiapine,
and will thus facilitate clinical informed consent for the clinical trial phase of the study.
Completion of the first part of the study will also serve as the screening component for part
II. Part II includes, first, obtaining written informed consent from eligible subjects, and
then randomly assigning them to continue quetiapine or to be switched to trazodone in
open-label "real world" fashion for the duration of 4 weeks, followed by another four weeks
of open, non-randomized follow- up. The purpose of the second part of the study is to
determine if trazodone is an adequate substitute for quetiapine, primarily in terms of
treating insomnia. The investigators hypothesize that trazodone will not be inferior to
quetiapine in maintaining good quality of sleep measured by sleep scales (i.e., scores will
not significantly worsen once switched). This study is open to Veterans in the VA system
only. Eligible subjects must have a history of "dual diagnosis" (i.e., a history of addiction
and mental illness).