MedTrace Logo

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

NCT04245748 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-08-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Escitalopram

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.

DRUG

Duloxetine

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.

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Jeffrey R Strawn, MD, FAACAP · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2025-07-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04245748 on ClinicalTrials.gov