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Selective Serotonin and Norepinephrine Reuptake Inhibitor
Antidepressants for Anxious Depression (DOTS-AD Trial)
Phase 4
Recruiting
Led By Jeffrey 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)
Must not have
Patients who are unable to swallow capsules.
A clinically-significant medical illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2 to 20
Awards & highlights
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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 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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot swallow capsules.
Select...
I have a serious health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2 to 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2 to 20
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
Change from Baseline in the Clinical Global Impression of Severity (CGI-S)
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
433 Previous Clinical Trials
636,319 Total Patients Enrolled
22 Trials studying Depression
3,262 Patients Enrolled for Depression
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)
Jeffrey R Strawn, MD, FAACAPPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Escitalopram
- Group 2: Duloxetine
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Timeline:
This trial has the following timeline:- 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.
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