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NCT01662297 · ClinicalTrials.gov registry record · Phase 4
Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans
A Phase 4 study, sponsored by VA Connecticut Healthcare System.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT01662297: Clinical Trial Phase 4 study, sponsored by VA Connecticut Healthcare System.
NCT01662297 is a Phase 4 study that was terminated before completion, run by VA Connecticut Healthcare System. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01662297, a Phase 4 study, was terminated before completion, sponsored by VA Connecticut Healthcare System.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study 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 signifi
Interventions
- DRUG Trazodone
- DRUG Quetiapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01662297
The ClinicalTrials.gov registry entry for NCT01662297 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Connecticut Healthcare System, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Trazodone is the first listed.
NCT01662297 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01662297 about?
NCT01662297 is a clinical study titled "Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans". 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 ph...
What is the current status of trial NCT01662297?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2012-07. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01662297?
The interventions under investigation include: Trazodone (DRUG), Quetiapine (DRUG).
Who is sponsoring clinical trial NCT01662297?
This trial is sponsored by VA Connecticut Healthcare System, which has 26 total clinical trials registered on ClinicalTrials.gov.
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