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

This study, called DOTS-AD, is looking for the best way to treat anxious depression. It tests two common medications: escitalopram (Lexapro) and duloxetine (Cymbalta). If your symptoms don't improve enough with the first medication, you might then receive an additional medication, clonazepam or pregabalin. The study is open to English-speaking adults aged 18 to 50 who have been diagnosed with anxiety and/or depression. Researchers will measure how well treatments work by looking at changes in your anxiety and overall illness severity over 20 weeks. The study plans to enroll 84 participants, but its current recruitment status is unclear.

Study design: This is an interventional study that will enroll 84 participants. It is double-blind, meaning neither you nor your doctor will know which treatment you are receiving.
What's involved: You would receive either escitalopram or duloxetine for 11 weeks. If your symptoms don't improve, you would then receive clonazepam or pregabalin for an additional 8 weeks.
Compensation: Not stated in the trial record.
Follow-up: Your anxiety and overall illness severity will be measured for up to 20 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

UNKNOWN

PHASE4Ages 18–50InterventionalTreatment

University of Cincinnati

~84 participants

Updated 2024-08-29 on ClinicalTrials.gov

What's tested:EscitalopramDuloxetine

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score

Measured over Week 2 to 20

+1 more outcome measured

Conditions

Anxious Depression

Depression

NCT04245748

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience
Cincinnati, Ohiostudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Heidi K Schroeder, BS

[email protected]

(513) 558-4422

Email the study team

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Eligibility criteria

Inclusion

Written, informed consent.

Patients must be fluent in the English.

18 to 50 years of age, inclusive, at Visit 1.

Patients must meet DSM-5 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI.99 Patients may also meet criteria for persistent depressive disorder or major depressive disorder however, these may not be the primary focus of treatment.

HAM-A score ≥20 at Visits 1 and 2.

Clinical Global Impressions- Severity (CGI-S) score ≥4 at Visits 1 and 2.

No clinically significant abnormalities on physical examination and EKG.

Negative pregnancy test at Visit 1 in females.

Negative urine drug screen at Visit 1.

Sexually active patients must practice a reliable method of contraception (Section 15.0) that will continue for the duration of the study and for a minimum of 30 days following the end of study participation. Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted:

For patients directly enrolling into Phase 2: treatment with escitalopram (or its racemic equivalent citalopram) or duloxetine for ≥6 weeks, at time of screening.

Exclusion

DSM-5 diagnosis other than generalized anxiety, social anxiety, separation anxiety or panic disorder(s) that is the primary focus of treatment.

A history of intellectual disability.

Suicide risk as determined by either: (1) any suicide attempt within the past 6 months and/or (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator.

Allergy, intolerance, non-response or hypersensitivity to escitalopram, duloxetine, pregabalin or clonazepam.

Subjects taking other medications that require a taper or washout of more than 5 days.

Patients who have initiated/terminated psychotherapy/behavior therapy within 1 month before Visit 2 (Baseline) will be excluded; if the patient is engaged in psychotherapy, it must have been stable for 1 month prior to baseline.

A clinically-significant medical illness.

QTc \>450 in males or \>460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG100

Alcohol or substance use disorder within 6 months of baseline (nicotine use is permitted).

Positive urine pregnancy test/pregnancy or breast feeding.

A positive urine drug screen.

Patients who are unable to swallow capsules.

What this trial measures

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total scoreWeek 2 to 20
The HAM-A rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total scores range from 0 to 56. A lower score is favorable.
Change from Baseline in the Clinical Global Impression of Severity (CGI-S)Week 2 to 20
CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.

Trialytics