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

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

Recruiting
18-50 years
All
Phase 4

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.

Study details
    Endogenous depression
    Depression
    Depression
    Anxious Depression

NCT04245748

University of Cincinnati

19 February 2024

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