Finding the best treatment sequence for anxious depression

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

This study is testing different treatment plans for adults with anxious depression to see which combination of medications helps them feel better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Cincinnati (Academic / other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT04245748 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of treatment sequences for anxious depression by first administering either escitalopram or duloxetine to participants for 11 weeks. Patients who do not achieve remission will then receive adjunctive treatment with either clonazepam or pregabalin for an additional 8 weeks. The study aims to adaptively randomize participants based on their response to the initial treatment, allowing for a tailored approach to managing persistent symptoms. A total of 84 adults will be enrolled, focusing on those with generalized, social, or separation anxiety disorders alongside depression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 50 who meet the criteria for anxiety disorders and have significant depressive symptoms.

Not a fit: Patients with anxiety or depression not meeting the study's specific diagnostic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment strategies for individuals suffering from anxious depression.

How similar studies have performed: Previous studies have shown promise in using adaptive treatment strategies for anxiety and depression, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. Surgical sterilization
  2. Oral contraceptives (e.g. estrogren-progestin combination or progestin)
  3. Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
  4. Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
  5. An intrauterine device
  6. Diaphragm plus condom.
* 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 Criteria:

* 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.

Where this trial is running

Cincinnati, Ohio

• University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Jeffrey R Strawn, MD, FAACAP — University of Cincinnati
• Study coordinator: Heidi K Schroeder, BS

Conditions Anxious Depression; Depression