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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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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 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 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:

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I cannot swallow capsules.

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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

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

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)

Awards & Highlights

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.

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.

0 / 12Eligibility criteria met