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

Launched by UNIVERSITY OF CINCINNATI · Jan 27, 2020

Keywords

ClinConnect Summary

**Summary of the DOTS-AD Clinical Trial**

The DOTS-AD clinical trial is studying the best way to treat anxious depression, a condition that includes symptoms of both anxiety and depression. This study is looking at two medications, duloxetine and escitalopram, which are commonly used to treat these conditions. Participants who still have symptoms after the initial treatment may receive additional medication, either clonazepam or pregabalin, to help improve their symptoms further. The trial is currently recruiting participants aged 18 to 50 who meet specific criteria, such as having a diagnosis of anxiety or depression.

To participate, individuals must be fluent in English, provide consent, and meet certain health guidelines. Participants can expect to be part of a structured treatment plan with regular check-ins to assess their progress. It’s important for potential participants to know that they cannot have certain other medical conditions or take specific medications during the trial. Overall, this study aims to find the most effective treatment sequence for those dealing with anxious depression, contributing to better care options in the future.

Gender

ALL

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.