EV-SoPRANO: Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
Study Details
Study Description
Brief Summary
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Detailed Description
Randomized, double-blind, placebo-controlled trial of an evidence-based antidepressant, sertraline, in youth (N=120) with generalized, separation and/or social anxiety disorders, seeks to evaluate the predictive value of plasma EV signatures. Patients will be randomized to sertraline (25-200 mg/day) or placebo (3:1) and total plasma EVs will be collected at baseline and serially during the course of the 12-week treatment period.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: sertraline 90 patients will be randomized to sertraline |
Drug: sertraline
Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)
Other Names:
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Placebo Comparator: Placebo 30 patient will be randomized to placebo |
Drug: sertraline
Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)
Other Names:
|
No Intervention: Healthy Control 30 healthy comparison subjects will be followed over the course of 12 weeks |
Outcome Measures
Primary Outcome Measures
- Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2 [Week 12]
Primary response outcome will be treatment response based on patients having attained a score on the Clinical Global Impression-Improvement Scale ≤ 2 at Week 12 or Last-Observation-Carried-Forward (LOCF).
Eligibility Criteria
Criteria
Inclusion Criteria for Patients with Anxiety :
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Written, informed assent and consent.
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Patients, parent/guardian/LAR must be fluent in the English.
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8-17 years of age, inclusive, at Visit 1, and who have a parent/guardian/LAR.
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Patients must meet DSM-5 criteria for generalized, social and/or separation anxiety disorder, confirmed by the MINI-KID with no lifetime history of mania, OCD or significant history of trauma exposure.
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PARS score ≥15 at Visits 1 and 2.
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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.
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No clinically significant abnormalities on physical examination.
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Negative pregnancy test at Visit 1 in females.
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Sexually active patients must practice a reliable method of contraception (Section 15.0) that will continue for the duration of the study and within 30 days following the end of study participation.
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Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted.
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surgical sterilization
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oral contraceptives (e.g., estrogen-progestin combination or progestin)
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transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g.,
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Depo-Provera)
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vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant
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II/Jadelle)
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an intrauterine device or
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diaphragm plus condom.
Inclusion Criteria for Healthy Controls:
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Written, informed assent and consent.
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Patients, parent/guardian/LAR must be fluent in the English.
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8 to 17 years of age, inclusive, at Visit 1, and who have a parent/guardian/LAR.
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No history of any DSM-5 disorders (nicotine use disorder is permitted, history of adjustment disorder is permitted), confirmed by the MINI-KID.
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Caregiver who is willing to consent to be responsible for safety monitoring of the patient, provide information about the patient.
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No clinically significant abnormalities on physical examination. Negative pregnancy test at Screening in females.
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Negative urine drug screen at Screening.
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No first-degree relatives with an affective, anxiety or psychotic disorder.
Exclusion Criteria for Patients with Anxiety Disorders and Healthy Comparison:
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Subjects Co-occurring DSM-5 diagnosis mood (except persistent depressive disorder, unspecified depressive disorder or co- occurring anxiety disorders, provided that the primary diagnosis is generalized, social and/or separation anxiety disorder(s)), eating, bipolar, or psychotic disorders.
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A history of treatment with SSRIs within 12 weeks of Visit 2 (Baseline) or current pharmacotherapy with CNS effects that require >5 half-lives for discontinuation.
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A history of major neurological or medical illness or head trauma with loss of consciousness for ≥5 minutes.
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Lifetime history of mania, OCD, or significant history of trauma exposure.
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History of hypersensitivity to sertraline.
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Lifetime diagnosis of intellectual disability or history of IQ <70.
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History of alcohol/substance use disorder or any substance abuse within the past 6 months (nicotine dependence is permitted).
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Current psychotherapy stable for <2 months prior to Visit 2 (Baseline).
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Females will not be eligible to participate if they are pregnant, breast feeding or lactating.
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The subject lives >100 miles from the University of Cincinnati or >90 minutes from the CU site or is not able to attend the follow-up visits.
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Patients who are unable to swallow capsules.
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Is currently considered at risk of suicide in the opinion of the investigator, represents an inappropriate risk to the participant and/or could confound the interpretation of the study results.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Columbia, New York State Psychiatric Institute | New York | New York | United States | 10032 |
2 | University of Cincinnati | Cincinnati | Ohio | United States | 45219 |
Sponsors and Collaborators
- University of Cincinnati
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Jeffrey R Strawn, MD, FAACAP, University of Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Strawn EV-SoPRANO
- R01HD098757