Actively Recruiting
Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)
Led by University of Cincinnati · Updated on 2024-08-29
84
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.
CONDITIONS
Official Title
Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written, informed consent.
- Fluent in English.
- 18 to 50 years old at initial visit.
- Meet DSM-5 criteria for generalized, social, or separation anxiety disorder and/or panic disorder, confirmed by MINI.
- May also have persistent depressive disorder or major depressive disorder, but not as the primary treatment focus.
- Hamilton Anxiety Rating Scale (HAM-A) score of 20 or higher at Visits 1 and 2.
- Clinical Global Impressions-Severity (CGI-S) score of 4 or higher at Visits 1 and 2.
- No significant abnormalities on physical exam and EKG.
- Negative pregnancy test at Visit 1 for females.
- Negative urine drug screen at Visit 1.
- Sexually active patients must use reliable contraception throughout the study and for 30 days after.
- For direct Phase 2 entry: at least 6 weeks of escitalopram (or citalopram) or duloxetine treatment at screening.
You will not qualify if you...
- Primary DSM-5 diagnosis other than generalized, social, separation anxiety, or panic disorder.
- History of intellectual disability.
- Suicide attempt within past 6 months or significant suicide risk at screening or baseline.
- Allergy, intolerance, or hypersensitivity to escitalopram, duloxetine, pregabalin, or clonazepam.
- Taking medications requiring taper or washout longer than 5 days.
- Started or stopped psychotherapy/behavior therapy within 1 month before baseline, unless stable for at least 1 month.
- Clinically significant medical illness.
- Prolonged QTc interval: >450 ms in males or >460 ms in females.
- Alcohol or substance use disorder within 6 months (nicotine allowed).
- Positive pregnancy test, pregnancy, or breastfeeding.
- Positive urine drug screen.
- Unable to swallow capsules.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
H
Heidi K Schroeder, BS
CONTACT
Z
Zoe N Neptune, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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