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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Treatments: Citalopram; Dexetimide; Duloxetine Hydrochloride

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.