Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Cincinnati
About this trial
Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.
Eligibility criteria
Qualifiers
Written, informed consent.
Patients must be fluent in the English.
18 to 50 years of age, inclusive, at Visit 1.
Patients must meet DSM-5 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI.99 Patients may also meet criteria for persistent depressive disorder or major depressive disorder however, these may not be the primary focus of treatment.
Disqualifiers
DSM-5 diagnosis other than generalized anxiety, social anxiety, separation anxiety or panic disorder(s) that is the primary focus of treatment.
A history of intellectual disability.
Suicide risk as determined by either: (1) any suicide attempt within the past 6 months and/or (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator.
Allergy, intolerance, non-response or hypersensitivity to escitalopram, duloxetine, pregabalin or clonazepam.
Trial design
Treatments tested in this trial
- Escitalopram
- Duloxetine
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov