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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Escitalopram
DrugEscitalopram, a SSRI, commercially known as LexaproTM, is commonly prescribed for anxiety disorders and is FDA-approved for acute and maintenance treatment of MDD and GAD.
Duloxetine
DrugDuloxetine, a SNRI, commercially known as CymbaltaTM, is FDA-approved for the treatment of GAD, MDD, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain in adults.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: EscitalopramActive comparator 1 intervention
Group B: DuloxetineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
The HAM-A rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total scores range from 0 to 56. A lower score is favorable.
Time frame
Week 2 to 202
Change from Baseline in the Clinical Global Impression of Severity (CGI-S)
CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.
Time frame
Week 2 to 20Sponsors and contacts
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Source ClinicalTrials.gov