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New treatment option for Anxiety
Official title Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A)
ClinicalTrials.gov ID: NCT04245436
What this study is testing
What is Duloxetine?
Duloxetine is an investigational medicine, given as an once-daily, being studied as a potential treatment for anxiety.
Also referred to as Cymbalta, Irenka.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17
You may be able to join if
- Written, informed assent and consent.
- Patients, parent/guardian/LAR must be fluent in the English.
- 12 to 17 years of age, inclusive, at Screening.
- Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI-KID.
- Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition...
You likely can't join if
- DSM-512 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...
- Allergy, intolerance, non-response or hypersensitivity to escitalopram or duloxetine.
- people 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), or who plan to initiate/change said...
See the full eligibility criteria
- Written, informed assent and consent.
- Patients, parent/guardian/LAR must be fluent in the English.
- 12 to 17 years of age, inclusive, at Screening.
- Patients must meet DSM-512 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI-KID.
- Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient's condition, oversee the administration of the investigational product.
- No clinically significant abnormalities on physical examination.
- Negative pregnancy test at Screening in females.
- Negative urine drug screen at Screening.
- 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...
- 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.
- DSM-512 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 or duloxetine.
- people 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), or who plan to initiate/change said therapies during the course of the study will be excluded; if the...
- A clinically-significant medical illness.
- QTc \>450 in males / \>460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG81
- Alcohol or substance use disorder within the past 6 months (nicotine use is permitted).
- Positive urine pregnancy test/pregnancy or breast feeding.
- A positive urine drug screen.
- Patients who are unable to swallow capsules.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.