Child Behavior DisordersSUAYNCT03448575
Safer Use of Antipsychotics in Youth
A study testing Intervention - Alert + CAP Review AND Enhanced BH Access in people with Child Behavior Disorders, run by Kaiser Permanente at 4 sites in United States.
Trial summary
This study tests the effectiveness of an intervention treatment algorithm vs. usual care control in a practical clinical trial. Control arm providers will receive a standard medication alert in the electronic medical record (EMR) when initiating an antipsychotic prescription for an eligible patient. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior Disorders
- What is being tested?
- Intervention - Alert + CAP Review AND Enhanced BH Access
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 733 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Mar 2018to 24 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient is ≥ 3 and < 18 years of age at the time of the encounter at which the study alert fired (index date);
- Patient is initiating a new episode of outpatient treatment with an antipsychotic medication. (New episodes are defined by no record of an antipsychotic medication being ordered within the health system as part of an outpatient care plan in the prior 180 days);
- Study service (BH navigation, bridging therapy, CAP consult) ordered in Epic for the patient; (e.g., provider removed antipsychotic order and still ordered study services);
Who cannot join
- Patient has a diagnosed psychotic disorder, mania, autism spectrum disorder, or intellectual disability;
- Patient was enrolled in the SUAY pilot study;
- The antipsychotic entered is prochlorperazine (Comazol®);
- An outpatient antipsychotic order is entered by a temporary provider in the health system (e.g., "doc of the day"). Orders placed by temporary providers do not count towards the 180 day medication free period for defining a new episode of care.
- The antipsychotic order was placed within an urgent care, emergency department, or inpatient setting (to avoid intervening during a crisis). Orders placed in these settings do not count towards the 180 day medication free period for defining a new episode of care.
- Primary language is not English
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kaiser Permanente Colorado Institute for Health Research
Aurora, Colorado, 80014
Nationwide Children's Hospital / Partners for Kids
Columbus, Ohio, 43205
Kaiser Permanente Center for Health Research - Northwest
Portland, Oregon, 97227
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98115
About this study
Official title: A Targeted Approach To A Safer Use of Antipsychotics In Youth
This study tests the effectiveness of an intervention treatment algorithm vs. usual care control in a practical clinical trial. Control arm providers will receive a standard medication alert in the electronic medical record (EMR) when initiating an antipsychotic prescription for an eligible patient. Intervention arm prescribers will receive an interactive medication alert in the EMR when prescribing for eligible patients and the patient and provider will enter the treatment algorithm (provider - medication alert plus clinical review by a child psychiatrist; patient - offer of personalized behavioral health navigation plus bridging therapy when appropriate). The study aims to recruit 800 eligible patients in 4 health systems.
Read the detailed description
SUAY is a practical clinical trial designed to test the effectiveness of an intervention aiming to improve the targeted and safer use of antipsychotic medications by guiding clinician-prescribing behavior of antipsychotics for children aged ≥ 3 and < 18 years and encouraging psychosocial therapy for eligible youth. The intervention includes a medication best practice alert in Epic, consultation with a child and adolescent psychiatrist, and extra support for patients and families to improve behavioral health service access. The trial will be conducted in 4 non-academic health systems. Each health system will randomize prescribers to one of two study arms, intervention and control. During patient encounters, entering an antipsychotic for a potentially eligible patient will cause either the control or intervention medication alert to fire in the electronic medical record. The control arm medication alert will point prescribing clinicians to relevant Choosing Wisely® recommendations. The intervention arm medication alert will inform prescribers that:
- Antipsychotics are not recommended 1st line treatment for non-psychotic disorders;
- A child and adolescent psychiatrist (CAP) will review antipsychotic usage by youth;
- Expedited access to bridging therapy, behavior health navigation, and/or a proactive consultation with a CAP may be ordered.
The intervention medication alert will point prescribing clinicians to both Choosing Wisely® recommendations and to SUAY clinical prescribing guidelines. SUAY guidelines were developed by a national expert consensus panel in a prior phase of the study.
Analytic data will be collected from automated data sources at the health systems. The primary outcomes are percent of children ordered an antipsychotic medication at 6 months of follow up, and total person-months of antipsychotic orders placed for participants during the study period.
- Conditions
- Child Behavior Disorders
- Being tested
- Control - Provider Medication Alert Only, Intervention - Alert + CAP Review AND Enhanced BH Access
- Keywords
- Youth, Mental Health, Psychotropic, Medication Safety, Quality Improvement
- Medical subject headings
- Child Behavior Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control - Provider Medication Alert OnlyOther
Simple text medication alert referencing Choosing Wisely guidelines.
Intervention - Alert + CAP Review AND Enhanced BH AccessOther
Interactive medication alert referencing SUAY Clinical Guidelines and offering options to keep/remove orders for the antipsychotic, virtual CAP consult, BH navigation for the patient, and access to bridging therapy for the patient.
| Study group | Role | What they receive |
|---|---|---|
| Control - Medication Alert Only | Sham comparator | The control arm medication alert is a simple text pop-up in the EMR that will inform the prescriber of Choosing Wisely® recommendations developed the American Psychiatric Association regarding antipsychotic medication use in children and adolescents. Receives: Other: Control - Provider Medication Alert Only |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Experimental | The intervention alert prompts the prescriber to keep/remove the antipsychotic order, and/or order any study services: behavioral health navigation, expedited psychotherapy access, virtual consult with a child and adolescent psychiatrist (CAP). Passive case review by the study CAP will occur for all intervention arm cases. A virtual consult will be scheduled if the prescriber ordered it or the CAP needs to discuss the case. The CAP will provide the prescriber with a written summary of his/her review.
Following review by the CAP, a navigator reaches out to the eligible intervention arm patient/family to offer extra support. The navigator's role is to (a) provide extra support to facilitate access and engagement in appropriate psychosocial therapies; (b) coordinate short-duration bridging therapy sessions for teens/families not engaged in psychotherapy, when appropriate; and (c) keep the prescriber informed of any clinically relevant updates. Receives: Other: Intervention - Alert + CAP Review AND Enhanced BH Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Youths With Antipsychotic Orders at 6 Months
Measured by medication orders placed within the health system
Measured: 180 day period following index date
Days' Supply of Antipsychotics Ordered for Youth
Average days' supply of antipsychotic medication (values fell between 1 and 180 days), as measured by the intended days' supply on the medication orders for each participant. Only orders placed within the health system were accounted for.
Measured: 180 day period following index date
Secondary outcomes (10)
Percent of Youths Using Antipsychotics at 6 Months
Measured by medication fill data available to the health system
Measured: 180 day period following index date
Days' Supply of Antipsychotic Use by Youth
Average days' supply of antipsychotic medication (values fell between 1 and 180 days), as measured by medication fill data available to the health system for each participant. Only pharmacy claims captured by the health system were accounted for.
Measured: 180 day period following index date
Emergency Department/Urgent Care Visit Frequency
Measured by utilization data; both for psychiatric crises and for all other reasons
Measured: 180 day period following index date
Baseline and Follow-up Safety Assessments - BMI
Percentage of patients with BMI measurements completed at baseline and 3 months
Measured: index date to 180 days post-index date
Change to Psychotropic Medication Treatment Plan
Percentage of patients with change to psychotropic medication treatment plan following exposure to study algorithm
Measured: 180 day period following index date
Behavioral Health (BH) Navigation Acceptance
Percent of intervention arm patients that agree to BH navigation
Measured: 180 day period following index date
Use of Usual Care Therapy
Percentage of patients attending two or more system-provided therapy sessions
Measured: 180 day period following index date
Use of Bridging Therapy
Percentage of patients attending two or more study-provided bridging therapy sessions
Measured: 180 day period following index date
Use of Usual Care Therapy Following Bridging Therapy
Of patients in study therapy, percentage who subsequently attend two or more system-provided therapy sessions
Measured: 180 day period following index date
Baseline and Follow-up Safety Assessments - Safety Lab Tests
Percentage of patients with safety lab tests ordered and completed at baseline and 3 months
Measured: index date to 180 days post-index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start29 Mar 2018
- Primary completion30 Jun 2020
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Child Behavior DisordersStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Providers are preassigned to one of two study arms: usual care control or intervention arm. Patients are assigned to the same arm as the provider triggering the best practice alert and study algorithm.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 733 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert B Penfold, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448575
- Sponsor's protocol ID
- HHSN271201600002C
- Acronym
- SUAY
- Status last verified
- Oct 2024
- First submitted
- 21 Feb 2018
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing plan is incorporated by reference into the contract governing the project. Any changes to the plan must be pre-approved by the NIH Contracting Officer. A de-identified database will be delivered to the NIH, along with a statistical report. Any datasets for public distribution (including to the National Database for Clinical Trials Related to Mental Illness) will be de-identified in compliance with HIPAA standard for de-identification.
Publications
Chavez LJ, Richards JE, Fishman P, Yeung K, Renz A, Quintana LM, Massimino S, Penfold RB. Cost of Implementing an Evidence-Based Intervention to Support Safer Use of Antipsychotics in Youth. Adm Policy Ment Health. 2023 Sep;50(5):725-733. doi: 10.1007/s10488-023-01273-y. Epub 2023 Jun 1.
PubMed 37261566Penfold RB, Thompson EE, Hilt RJ, Schwartz N, Robb AS, Correll CU, Newton D, Rogalski K, Earls MF, Kowatch RA, Beck A, Yarborough BJH, Crystal S, Vitiello B, Kelleher KJ, Simon GE. Development of a Symptom-Focused Model to Guide the Prescribing of Antipsychotics in Children and Adolescents: Results of the First Phase of the Safer Use of Antipsychotics in Youth (SUAY) Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):93-102. doi: 10.1016/j.jaac.2021.04.010. Epub 2021 May 4.
PubMed 34256967Chavez LJ, Kelleher KJ, Beck A, Clarke GN, Penfold RB. Trends Over Time in Antipsychotic Initiation at a Large Children's Health Care System. J Child Adolesc Psychopharmacol. 2021 Jun;31(5):381-386. doi: 10.1089/cap.2020.0190.
PubMed 34143677Penfold RB, Thompson EE, Hilt RJ, Kelleher KJ, Schwartz N, Beck A, Clarke GN, Ralston JD, Hartzler AL, Coley RY, Akosile M, Vitiello B, Simon GE. Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol. Contemp Clin Trials. 2020 Dec;99:106184. doi: 10.1016/j.cct.2020.106184. Epub 2020 Oct 20.
PubMed 33091587Schoenfelder Gonzalez E, Myers K, Thompson EE, King DA, Glass AM, Penfold RB. Developing home-based telemental health services for youth: Practices from the SUAY Study. J Telemed Telecare. 2021 Feb;27(2):110-115. doi: 10.1177/1357633X19863208. Epub 2019 Jul 25.
PubMed 31342851
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Targeted Approach To A Safer Use of Antipsychotics In Youth
- ClinicalTrials.gov ID
- NCT03448575
- Acronym / sponsor ID
- SUAY / HHSN271201600002C
- Conditions
- Child Behavior Disorders
- Keywords
- Youth, Mental Health, Psychotropic, Medication Safety, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital, Seattle Children's Hospital, University of Washington
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests the effectiveness of an intervention treatment algorithm vs. usual care control in a practical clinical trial. Control arm providers will receive a standard medication alert in the electronic medical record (EMR) when initiating an antipsychotic prescription for an eligible patient. Intervention arm prescribers will receive an interactive medication alert in the EMR when prescribing for eligible patients and the patient and provider will enter the treatment algorithm (provider - medication alert plus clinical review by a child psychiatrist; patient - offer of personalized behavioral health navigation plus bridging therapy when appropriate). The study aims to recruit 800 eligible patients in 4 health systems.
Detailed description
SUAY is a practical clinical trial designed to test the effectiveness of an intervention aiming to improve the targeted and safer use of antipsychotic medications by guiding clinician-prescribing behavior of antipsychotics for children aged ≥ 3 and < 18 years and encouraging psychosocial therapy for eligible youth. The intervention includes a medication best practice alert in Epic, consultation with a child and adolescent psychiatrist, and extra support for patients and families to improve behavioral health service access. The trial will be conducted in 4 non-academic health systems. Each health system will randomize prescribers to one of two study arms, intervention and control. During patient encounters, entering an antipsychotic for a potentially eligible patient will cause either the control or intervention medication alert to fire in the electronic medical record. The control arm medication alert will point prescribing clinicians to relevant Choosing Wisely® recommendations. The intervention arm medication alert will inform prescribers that:
- Antipsychotics are not recommended 1st line treatment for non-psychotic disorders;
- A child and adolescent psychiatrist (CAP) will review antipsychotic usage by youth;
- Expedited access to bridging therapy, behavior health navigation, and/or a proactive consultation with a CAP may be ordered.
The intervention medication alert will point prescribing clinicians to both Choosing Wisely® recommendations and to SUAY clinical prescribing guidelines. SUAY guidelines were developed by a national expert consensus panel in a prior phase of the study.
Analytic data will be collected from automated data sources at the health systems. The primary outcomes are percent of children ordered an antipsychotic medication at 6 months of follow up, and total person-months of antipsychotic orders placed for participants during the study period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Providers are preassigned to one of two study arms: usual care control or intervention arm. Patients are assigned to the same arm as the provider triggering the best practice alert and study algorithm.
| Arm | Type | Receives |
|---|---|---|
| Control - Medication Alert Only | Sham comparator | Other: Control - Provider Medication Alert OnlyThe control arm medication alert is a simple text pop-up in the EMR that will inform the prescriber of Choosing Wisely® recommendations developed the American Psychiatric Association regarding antipsychotic medication use in children and adolescents. |
| Intervention - Alert + CAP Review AND Enhanced BH Access | Experimental | Other: Intervention - Alert + CAP Review AND Enhanced BH AccessThe intervention alert prompts the prescriber to keep/remove the antipsychotic order, and/or order any study services: behavioral health navigation, expedited psychotherapy access, virtual consult with a child and adolescent psychiatrist (CAP). Passive case review by the study CAP will occur for all intervention arm cases. A virtual consult will be scheduled if the prescriber ordered it or the CAP needs to discuss the case. The CAP will provide the prescriber with a written summary of his/her review. Following review by the CAP, a navigator reaches out to the eligible intervention arm patient/family to offer extra support. The navigator's role is to (a) provide extra support to facilitate access and engagement in appropriate psychosocial therapies; (b) coordinate short-duration bridging therapy sessions for teens/families not engaged in psychotherapy, when appropriate; and (c) keep the prescriber informed of any clinically relevant updates. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient is ≥ 3 and < 18 years of age at the time of the encounter at which the study alert fired (index date);
- Patient is initiating a new episode of outpatient treatment with an antipsychotic medication. (New episodes are defined by no record of an antipsychotic medication being ordered within the health system as part of an outpatient care plan in the prior 180 days);
- Study service (BH navigation, bridging therapy, CAP consult) ordered in Epic for the patient; (e.g., provider removed antipsychotic order and still ordered study services);
Key exclusion criteria (6 listed)
- Patient has a diagnosed psychotic disorder, mania, autism spectrum disorder, or intellectual disability;
- Patient was enrolled in the SUAY pilot study;
- The antipsychotic entered is prochlorperazine (Comazol®);
- An outpatient antipsychotic order is entered by a temporary provider in the health system (e.g., "doc of the day"). Orders placed by temporary providers do not count towards the 180 day medication free period for defining a new episode of care.
- The antipsychotic order was placed within an urgent care, emergency department, or inpatient setting (to avoid intervening during a crisis). Orders placed in these settings do not count towards the 180 day medication free period for defining a new episode of care.
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 |
|---|---|---|
| Control - Provider Medication Alert OnlySimple text medication alert referencing Choosing Wisely guidelines. | Other | Control - Medication Alert Only |
| Intervention - Alert + CAP Review AND Enhanced BH AccessInteractive medication alert referencing SUAY Clinical Guidelines and offering options to keep/remove orders for the antipsychotic, virtual CAP consult, BH navigation for the patient, and access to bridging therapy for the patient. | Other | Intervention - Alert + CAP Review AND Enhanced BH Access |
Primary outcome
Percent of Youths With Antipsychotic Orders at 6 Months
Time frame: 180 day period following index date
Measured by medication orders placed within the health system
Days' Supply of Antipsychotics Ordered for Youth
Time frame: 180 day period following index date
Average days' supply of antipsychotic medication (values fell between 1 and 180 days), as measured by the intended days' supply on the medication orders for each participant. Only orders placed within the health system were accounted for.
10 secondary outcomes
Percent of Youths Using Antipsychotics at 6 Months
Time frame: 180 day period following index date
Days' Supply of Antipsychotic Use by Youth
Time frame: 180 day period following index date
Emergency Department/Urgent Care Visit Frequency
Time frame: 180 day period following index date
Baseline and Follow-up Safety Assessments - BMI
Time frame: index date to 180 days post-index date
Change to Psychotropic Medication Treatment Plan
Time frame: 180 day period following index date
Behavioral Health (BH) Navigation Acceptance
Time frame: 180 day period following index date
Use of Usual Care Therapy
Time frame: 180 day period following index date
Use of Bridging Therapy
Time frame: 180 day period following index date
Use of Usual Care Therapy Following Bridging Therapy
Time frame: 180 day period following index date
Baseline and Follow-up Safety Assessments - Safety Lab Tests
Time frame: index date to 180 days post-index date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37261566Chavez LJ, Richards JE, Fishman P, Yeung K, Renz A, Quintana LM, Massimino S, Penfold RB. Cost of Implementing an Evidence-Based Intervention to Support Safer Use of Antipsychotics in Youth. Adm Policy Ment Health. 2023 Sep;50(5):725-733. doi: 10.1007/s10488-023-01273-y. Epub 2023 Jun 1.
- Derived from this study: PubMed 34256967Penfold RB, Thompson EE, Hilt RJ, Schwartz N, Robb AS, Correll CU, Newton D, Rogalski K, Earls MF, Kowatch RA, Beck A, Yarborough BJH, Crystal S, Vitiello B, Kelleher KJ, Simon GE. Development of a Symptom-Focused Model to Guide the Prescribing of Antipsychotics in Children and Adolescents: Results of the First Phase of the Safer Use of Antipsychotics in Youth (SUAY) Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):93-102. doi: 10.1016/j.jaac.2021.04.010. Epub 2021 May 4.
- Derived from this study: PubMed 34143677Chavez LJ, Kelleher KJ, Beck A, Clarke GN, Penfold RB. Trends Over Time in Antipsychotic Initiation at a Large Children's Health Care System. J Child Adolesc Psychopharmacol. 2021 Jun;31(5):381-386. doi: 10.1089/cap.2020.0190.
- Derived from this study: PubMed 33091587Penfold RB, Thompson EE, Hilt RJ, Kelleher KJ, Schwartz N, Beck A, Clarke GN, Ralston JD, Hartzler AL, Coley RY, Akosile M, Vitiello B, Simon GE. Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol. Contemp Clin Trials. 2020 Dec;99:106184. doi: 10.1016/j.cct.2020.106184. Epub 2020 Oct 20.
- Derived from this study: PubMed 31342851Schoenfelder Gonzalez E, Myers K, Thompson EE, King DA, Glass AM, Penfold RB. Developing home-based telemental health services for youth: Practices from the SUAY Study. J Telemed Telecare. 2021 Feb;27(2):110-115. doi: 10.1177/1357633X19863208. Epub 2019 Jul 25.
- Individual participant dataSharing planned: Yes. The data sharing plan is incorporated by reference into the contract governing the project. Any changes to the plan must be pre-approved by the NIH Contracting Officer. A de-identified database will be delivered to the NIH, along with a statistical report. Any datasets for public distribution (including to the National Database for Clinical Trials Related to Mental Illness) will be de-identified in compliance with HIPAA standard for de-identification.
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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.
Robert B Penfold, PhD principal investigator
Kaiser Permanente
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention - Alert + CAP Review AND Enhanced BH Access in people with Child Behavior Disorders, run by Kaiser Permanente at 4 sites 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Youths With Antipsychotic Orders at 6 Months (time frame: 180 day period following index date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448575, which also lists 5 linked publications.
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 31 Oct 2024.