RecruitingPhase 4NCT04245748

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


Sponsor

University of Cincinnati

Enrollment

84 participants

Start Date

Mar 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing different medication treatment sequences in adults ages 18–50 who have anxiety mixed with depression, to find out which order and combination of treatments works best. **You may be eligible if:** - You are between 18 and 50 years old - You have been diagnosed with generalized anxiety, social anxiety, separation anxiety, or panic disorder - Your anxiety symptoms are at a moderate-to-severe level, confirmed by standard rating scales - You are fluent in English - You have no significant abnormalities on physical exam or EKG **You may NOT be eligible if:** - You are pregnant (a negative test is required at enrollment) - You test positive for drugs on a urine screen at enrollment - You are sexually active without using reliable contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEscitalopram

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.

DRUGDuloxetine

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.


Locations(1)

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience

Cincinnati, Ohio, United States

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NCT04245748


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