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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT04245748
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Escitalopram — DRUG
    Escitalopram, 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 — DRUG
    Duloxetine, 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.

Study Details

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

Key Dates

Start date
Mar 1, 2020
Status verified
Aug 2024
Primary completion
Jul 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Escitalopram
    Adaptively randomized, double-blind treatment with escitalopram for 11 weeks in Phase 1. Non-remitting patients will be randomized in Phase 2 to adjunctive clonazepam or pregabalin for 8 weeks. Additionally, adults who are already treated with escitalopram or citalopram for at least 6 weeks prior to screening, may enter Phase 2 and be randomized to adjunctive clonazepam or pregabalin for 8 weeks.
  • Active Comparator: Duloxetine
    Adaptively randomized, double-blind treatment with duloxetine for 11 weeks in Phase 1. Non-remitting patients will be randomized in Phase 2 to adjunctive clonazepam or pregabalin for 8 weeks. Additionally, adults who are already treated with duloxetine for at least 6 weeks prior to screening, may enter Phase 2 and be randomized to adjunctive clonazepam or pregabalin for 8 weeks.

Primary Outcome Measure

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score [ Time Frame: Week 2 to 20 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati, Department of Psychiatry & Behavioral NeuroscienceCincinnatiOhio45219
Jeffrey R Strawn, MD, FAACAP
[email protected]
513-558-4315
Heidi K Schroeder, BS
[email protected]
(513) 558-4422

Find similar trials in Cincinnati, OH

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience· Cincinnati, OH

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