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Antidepressants for Anxious Depression (DOTS-AD Trial)
DOTS-AD Trial Summary
This trial is testing two different antidepressants to see which one works better, then adding a second medication if needed.
DOTS-AD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDOTS-AD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DOTS-AD Trial Design
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Who is running the clinical trial?
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- I am on medication that cannot be stopped immediately and requires more than 5 days to safely stop.You must use both a diaphragm and a condom during the study.I use a vaginal ring or contraceptive implant for birth control.You are allergic or have had bad reactions to escitalopram, duloxetine, pregabalin, or clonazepam.I use skin patches or injections for birth control.You have a history of having difficulty with learning or understanding things.You have struggled with alcohol or drug addiction within the past 6 months, but smoking is allowed.My main mental health issue is not anxiety or panic disorder.I cannot swallow capsules.I am using or will use an approved method of birth control during and after the study.I am between 18 and 50 years old.My drug test at the first visit was negative.You have an intrauterine device (IUD) inserted in your uterus.I have been treated with escitalopram, citalopram, or duloxetine for at least 6 weeks.I have been surgically sterilized.I have taken a pregnancy test and it was negative.I have not started or stopped any mental health therapy in the last month.I have been diagnosed with an anxiety disorder.My physical exam and heart test results are normal.I have a serious health condition.Your anxiety level, as measured by a questionnaire, is very high (score of 20 or more) at two different visits.You have a score of 4 or higher on a scale that measures how severe your condition is.I am currently using oral contraceptives.
- Group 1: Escitalopram
- Group 2: Duloxetine
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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