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Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A) (AtLAS-A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04245436
Recruitment Status : Not yet recruiting
First Posted : January 29, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey Strawn, MD, University of Cincinnati

Brief Summary:
Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by open-label naturalistic follow-up.

Condition or disease Intervention/treatment Phase
Anxiety Depressive Symptoms Drug: Duloxetine Drug: Escitalopram Phase 4

Detailed Description:
To identify predictors of the magnitude and trajectory of response to flexibly-dosed duloxetine and escitalopram response in adolescents with anxiety, including those with depressive symptoms. And also to examine long-term predictors of sustained response and relapse in adolescents. To examine predictors of developing depressive disorders in anxious adolescents.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up.
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : August 2024


Arm Intervention/treatment
Active Comparator: Duloxetine
Patients randomized to duloxetine, treatment will be initiated at 30 mg qAM through Week 4 (V5) (consistent with the registration trial for duloxetine in pediatric patients with generalized anxiety disorder). Then, duloxetine will be increased to 60 mg qAM at Week 4 (V5) and will be continued at this dose until Week 6 (V6) or the end of the acute phase of the study. Beginning at Week 6 (V6), duloxetine may be increased to 90 mg daily and at Week 8 (V7), may be increased to 120 mg daily.
Drug: Duloxetine
Encapsulated duloxetine 30 mg, 60 mg; once-daily
Other Names:
  • Cymbalta
  • Irenka

Active Comparator: Escitalopram
Patients randomized to escitalopram, will initiate treatment at 5 mg qAM for 1 week and then 10 mg qAM (the recommended starting dose for adolescents 12-17 years and the dose used in the pediatric registration trials). After Week 4 (V5), escitalopram will be increased to 15 mg and this dose will be continued until either Week 6 (V6) or the end of the acute phase of the study; however, at Week 6 (V6), escitalopram may be increased to 20 mg qAM based on efficacy.
Drug: Escitalopram
Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily
Other Name: Lexapro




Primary Outcome Measures :
  1. Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score [ Time Frame: Baseline to Week 24 months (Early Term) ]
    The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders in children and adolescents. The PARS score is derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7)

  2. Change from Baseline in the Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline to Week 10 (Early Term) ]
    CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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 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.

Exclusion Criteria:

  • 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.
  • 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), or who plan to initiate/change said therapies during the course of the study 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 / >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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245436


Contacts
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Contact: Jeffrey R Strawn, MD 513-558-4315 strawnjr@ucmail.uc.edu
Contact: Sara T Varney 513-558-2931 varneysa@ucmail.uc.edu

Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Jeffrey R Strawn, MD University of Cincinnati
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Responsible Party: Jeffrey Strawn, MD, Associate professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT04245436    
Other Study ID Numbers: Strawn AtLAS-A
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Duloxetine Hydrochloride
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Peripheral Nervous System Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Analgesics
Sensory System Agents
Dopamine Agents