Behavioral Science & Ethics USMLE Step 1 Practice Question
A pharmaceutical company is conducting a Phase III trial of a novel selective serotonin reuptake inhibitor (SSRI) for treatment-resistant major depressive disorder. Researchers randomly assign 150 patients with confirmed diagnoses to receive either the investigational SSRI or an identical-appearing placebo tablet daily for 12 weeks. Research coordinators who administer the Hamilton Depression Rating Scale at baseline, 6 weeks, and 12 weeks are unaware of treatment assignment. Patients are also blinded to their group allocation. At the conclusion of the trial, the investigators will compare mean depression scores between groups using intention-to-treat analysis. Which of the following best describes the methodological features of this study design?
Answer choices
- ASingle-blind, placebo-controlled randomized controlled trial with stratified randomization
- BDouble-blind, active comparator randomized controlled trial with crossover design
- CDouble-blind, placebo-controlled randomized controlled trial with parallel group assignmentCorrect answer
- DOpen-label, non-randomized comparative effectiveness trial with matched controls
- ETriple-blind, placebo-controlled randomized controlled trial with post-hoc stratification
- FQuasi-experimental design with single-blinded outcome assessment and historical controls
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