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Selective Serotonin and Norepinephrine Reuptake Inhibitor

Antidepressants for Anxious Depression (DOTS-AD Trial)

Phase 4
Recruiting
Led By Jeffrey R Strawn, MD, FAACAP
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2 to 20
Awards & highlights

DOTS-AD Trial Summary

This trial is testing two different antidepressants to see which one works better, then adding a second medication if needed.

Who is the study for?
This trial is for English-speaking adults aged 18-50 with anxiety and depression, confirmed by specific criteria and tests. They must have a certain score on the HAM-A scale, no significant health issues or drug use, not be pregnant or breastfeeding, and agree to reliable contraception.Check my eligibility
What is being tested?
The study compares two antidepressants: Escitalopram and Duloxetine. It starts with one of these drugs chosen randomly. If symptoms persist, participants are then given either Clonazepam or Pregabalin in addition to their initial treatment.See study design
What are the potential side effects?
Possible side effects include nausea, headache, sleep disturbances for both medications; increased sweating or dry mouth for Duloxetine; sexual dysfunction for Escitalopram. Clonazepam may cause drowsiness while Pregabalin can lead to dizziness.

DOTS-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I use a vaginal ring or contraceptive implant for birth control.
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I use skin patches or injections for birth control.
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I am using or will use an approved method of birth control during and after the study.
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I am between 18 and 50 years old.
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My drug test at the first visit was negative.
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I have been treated with escitalopram, citalopram, or duloxetine for at least 6 weeks.
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I have been surgically sterilized.
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I have taken a pregnancy test and it was negative.
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I have been diagnosed with an anxiety disorder.
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My physical exam and heart test results are normal.
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I am currently using oral contraceptives.

DOTS-AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2 to 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2 to 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
Change from Baseline in the Clinical Global Impression of Severity (CGI-S)

DOTS-AD Trial Design

2Treatment groups
Active Control
Group I: EscitalopramActive Control1 Intervention
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.
Group II: DuloxetineActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
427 Previous Clinical Trials
634,287 Total Patients Enrolled
21 Trials studying Depression
1,327 Patients Enrolled for Depression
Jeffrey R Strawn, MD, FAACAPPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
150 Total Patients Enrolled
Jeffrey Strawn, MD, FAACAPPrincipal Investigator - University of Cincinnati
HealthSouth Northern Kentucky Rehabilitation Hospital
University Of Cincinnati College Of Medicine (Medical School)
University Hosp, Inc (Residency)

Media Library

Duloxetine (Selective Serotonin and Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04245748 — Phase 4
Depression Research Study Groups: Escitalopram, Duloxetine
Depression Clinical Trial 2023: Duloxetine Highlights & Side Effects. Trial Name: NCT04245748 — Phase 4
Duloxetine (Selective Serotonin and Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04245748 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals aged 25 or older enroll in this clinical experiment?

"Those wishing to partake in this medical trial must be aged between 18 and 50 years old. There are 202 studies available for individuals below the age of majority, while 1016 can be found for senior citizens over 65 years of age."

Answered by AI

Has Escitalopram previously been examined through an experiment?

"Currently, there are 41 clinical trials for Escitalopram of which 8 have reached Phase 3. While most tests are located in Redwood City, California, a total of 820 sites across the US offer this trial to patients."

Answered by AI

Is this clinical experiment currently recruiting participants?

"This research is actively recruiting, as confirmed by clinicaltrials.gov. It was posted on March 1st 2020 and the latest update took place February 14th 2022."

Answered by AI

What common ailments is Escitalopram routinely employed to treat?

"Escitalopram is commonly prescribed to alleviate diabetic peripheral neuropathy, yet also curbs a range of other ailments like knee pain, major depressive disorder (mdd), and musculoskeletal system disorders."

Answered by AI

How many participants have been accepted into this clinical trial?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, posted on March 1st 2020 and last updated February 14th 2022, is currently recruiting patients. 84 participants are required to be found from a single site for the study's completion."

Answered by AI

Has Escitalopram been granted regulatory assent to be marketed?

"We at Power rate Escitalopram's safety as a 3 due to this being Phase 4 trial, which implies the drug has already been sanctioned."

Answered by AI

Am I eligible to contribute to this research endeavor?

"This clinical trial is accepting eighty-four individuals between the ages of eighteen and fifty who have been diagnosed with at least one DSM-5 anxiety or depression disorder. A minimum HAM-A score of 20, a Clinical Global Impressions Severity (CGI-S) score of 4, normal physical examination results, an EKG reading without abnormalities, negative pregnancy test for female patients and proof/confirmation that they have undergone surgical sterilization must also be met to qualify for inclusion in this study."

Answered by AI
~6 spots leftby Jul 2024