Anxiety DisordersPhase 4EV-SoPRANONCT04221997
Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.
A Phase 4 study testing sertraline in people with Anxiety Disorders, run by University of Cincinnati at 1 site in United States.
Trial summary
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- sertraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written, informed assent and consent.
- Patients, parent/guardian/LAR must be fluent in the English.
- 8-17 years of age, inclusive, at Visit 1, and who have a parent/guardian/LAR.
- 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.
- PARS score ≥15 at Visits 1 and 2.
- 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.
- Negative pregnancy test at Visit 1 in females.
- 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.
- 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., estrogen-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 or
- diaphragm plus condom.
- Written, informed assent and consent.
- Patients, parent/guardian/LAR must be fluent in the English.
- 8 to 17 years of age, inclusive, at Visit 1, and who have a parent/guardian/LAR.
- No history of any DSM-5 disorders (nicotine use disorder is permitted, history of adjustment disorder is permitted), 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.
- No clinically significant abnormalities on physical examination. Negative pregnancy test at Screening in females.
- Negative urine drug screen at Screening.
- No first-degree relatives with an affective, anxiety or psychotic disorder.
- Exclusion Criteria for Patients with Anxiety Disorders and Healthy Comparison:
- 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.
- 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.
- A history of major neurological or medical illness or head trauma with loss of consciousness for ≥5 minutes.
- Lifetime history of mania, OCD, or significant history of trauma exposure.
- History of hypersensitivity to sertraline.
- Lifetime diagnosis of intellectual disability or history of IQ <70.
- History of alcohol/substance use disorder or any substance abuse within the past 6 months (nicotine dependence is permitted).
- Current psychotherapy stable for <2 months prior to Visit 2 (Baseline).
- Females will not be eligible to participate if they are pregnant, breast feeding or lactating.
- 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.
- Patients who are unable to swallow capsules.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Heidi K Schroeder, BS, 513-558-4422, heysehk@uc.edu
Jeffrey R Strawn, MD
About this study
Official title: Extracellular Vesicles as Predictors of Antidepressant Outcomes in Pediatric Anxiety (EV-SOPRANO)
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- sertraline
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Also called Zoloft
Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)
| Study group | Role | What they receive |
|---|---|---|
| sertraline | Experimental | 90 patients will be randomized to sertraline Receives: Drug: sertraline |
| Placebo | Placebo comparator | 30 patient will be randomized to placebo Receives: Drug: sertraline |
| Healthy Control | No intervention | 30 healthy comparison subjects will be followed over the course of 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2
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).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Nov 2019
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- During the acute treatment phase, 90 patients will be randomized to sertraline and 30 patients will be randomized to placebo (3:1).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Jeffrey Strawn, MD, University of Cincinnati
- Investigators
- Jeffrey R Strawn, MD, FAACAP, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221997
- Sponsor's protocol ID
- Strawn EV-SoPRANO
- Other IDs
- R01HD098757
- Acronym
- EV-SoPRANO
- Status last verified
- Oct 2024
- First submitted
- 6 Jan 2020
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular Vesicles as Predictors of Antidepressant Outcomes in Pediatric Anxiety (EV-SOPRANO)
- ClinicalTrials.gov ID
- NCT04221997
- Acronym / sponsor ID
- EV-SoPRANO / Strawn EV-SoPRANO
- Conditions
- Anxiety Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multicenter, acute, randomized, double-blind, placebo-controlled, flexible-dose trial with the treatment of sertraline.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- During the acute treatment phase, 90 patients will be randomized to sertraline and 30 patients will be randomized to placebo (3:1).
| Arm | Type | Receives |
|---|---|---|
| sertraline | Experimental | Drug: sertraline90 patients will be randomized to sertraline |
| Placebo | Placebo comparator | Drug: sertraline30 patient will be randomized to placebo |
| Healthy Control | No intervention | –30 healthy comparison subjects will be followed over the course of 12 weeks |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (39 listed)
- Written, informed assent and consent.
- Patients, parent/guardian/LAR must be fluent in the English.
- 8-17 years of age, inclusive, at Visit 1, and who have a parent/guardian/LAR.
- 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.
- PARS score ≥15 at Visits 1 and 2.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertralineAlso: ZoloftSertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs) | Drug | Placebo, sertraline |
Primary outcome
Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey R Strawn, MD, FAACAP principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sertraline in people with Anxiety Disorders, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi K Schroeder, BS (513-558-4422, heysehk@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.