Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD) — DOTS-AD  

Depression Clinical Trial

Official title: Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)

Status Recruiting

Clinical Trial Summary

Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.

Clinical Trial Description

The study will consist of 2 phases (Figure 1). Eighty-four adults will be enrolled in Phase 1 and will be adaptively randomized (initially 1:1) to acute, double-blind treatment with escitalopram or duloxetine for 11 weeks. Remission status will be determined at week 10. Remitting patients (CGI-S ≤2) will resume treatment as usual, which may consist of outpatient referral. Non-remitting patients (CGI-S ≥3), will continue into Phase 2 and will be randomized to adjunctive clonazepam or pregabalin for 8 weeks. Twenty adults treated with escitalopram (or its racemic equivalent, citalopram) or duloxetine for ≥6 weeks (at screening) will be enrolled into Phase 2 and will be randomized to receive adjunctive clonazepam or pregabalin for 8 weeks. ;

Related Conditions & MeSH terms

• Anxious Depression
• Depression
• Depressive Disorder

• NCT number: NCT04245748
• Study type: Interventional
• Source: University of Cincinnati
• Contact: Heidi K Schroeder, BS
• Phone: (513) 558-4422
• Email: heysehk@uc.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Completion date: December 31, 2024