Trial intelligence / Profile preview

Comparison of Quetiapine and Trazodone for Insomnia in Veterans

NCT01662297Phase 4

Key facts

Status: Terminated
Start: Jul 2012
Primary completion: Oct 2015
Countries: 1
Sponsor: United States Department of Veterans Affairs
Modality: Small Molecules

Drugs: trazodone
Conditions: Insomnia

Overview

Phase 4, randomised, open-label trial of trazodone in Insomnia (2 arms), sponsored by United States Department of Veterans Affairs. Primary endpoint: Pittsburgh Sleep Quality Inventory at 8 weeks. Started Jul 2012; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

Quetiapine Maintenance
Continue current Quetiapine prescription.
Trazodone Switch
Switch to Trazodone (up to 400mg daily).

Who it enrols

Veterans with a dual diagnosis (history of substance use and mental disorder) currently taking Quetiapine for insomnia for at least 1 month.

Endpoints

Primary

Pittsburgh Sleep Quality Inventory8 weeks

Secondary

Insomnia Severity Index8 weeks
Epworth Sleepiness Scale8 weeks
RAND Short Form 36 Item Health Survey8 weeks
Brief Symptom Inventory8 weeks
Alcohol Urge Questionnaire8 weeks
Percentage of Heavy Drinking Days8 weeks
Percentage of Negative Urine Drug Screens8 weeks
Medical Outcomes Study Sleep Scale8 weeks

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