NCT04245748 · University of Cincinnati
Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)
(DOTS-AD)
What this study is about
Acute, where neither patients nor doctors know which treatment is given, adaptively randomly assigned treatment with duloxetine or escitalopram, followed by where neither patients nor doctors know which treatment is given, randomly assigned adjunctive treatment with clonazepam or pregabalin for persistent symptoms.
View original scientific description
Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.
Interventions
DRUG
Escitalopram
Escitalopram, a SSRI, commercially known as LexaproTM, is commonly prescribed for anxiety disorders and is FDA-approved for acute and maintenance treatment of MDD and GAD.
DRUG
Duloxetine
Duloxetine, a SNRI, commercially known as CymbaltaTM, is FDA-approved for the treatment of GAD, MDD, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain in adults.
Primary outcome measures
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score
Time frame: Week 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)
Time frame: Week 2 to 20
CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- Surgical sterilization
- Oral contraceptives (e.g. estrogren-progestin combination or progestin)
- Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
- Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
- An intrauterine device
- 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
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 29, 2024 · Source of record for eligibility and locations