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Data-Driven Care Approach for Psychosis (EPI-CAL Trial)

N/A
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
FEP individuals, ages 12-30, who have experienced the onset of an affective (bipolar or major depression with psychotic features) or non-affective psychotic disorder (schizophrenia, schizoaffective, schizophreniform, brief psychotic, other specified or unspecified schizophrenia spectrum disorders) within the past 5 years and are receiving early psychosis services at one of the study sites.
Clinical high risk (CHR) individuals, ages 12-30, who have no history of psychosis and will demonstrate attenuated psychotic symptoms consistent with the Structured Interview for Prodromal Syndromes (SIPS), or genetic risk (first-degree relative with psychosis) in conjunction with a substantial drop in functioning over the past year.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, maximum of 5 years
Awards & highlights

EPI-CAL Trial Summary

This trial is testing whether a new method of collecting and visualizing data on patients with early psychosis will help create a more effective treatment plan and improve outcomes.

Who is the study for?
This trial is for young people aged 12-30 who've had their first episode of psychosis within the last 5 years and are getting treatment at participating sites. It's also open to family members over age 18, care providers, community stakeholders, and individuals at high risk but without a full-blown psychosis.Check my eligibility
What is being tested?
The study aims to create a network in California that uses mobile health tech and clinician dashboards to track patient data on early psychosis. They're testing how well they can collect this data across clinics and developing a tool to measure untreated psychosis duration.See study design
What are the potential side effects?
Since this trial focuses on data collection rather than medication or medical procedures, traditional side effects aren't applicable. However, participants may experience discomfort or privacy concerns related to sharing personal health information.

EPI-CAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am aged 12-30 and was diagnosed with a psychotic disorder in the last 5 years.
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I am aged 12-30, at high risk for psychosis, with symptoms or a family history, and have seen a drop in my daily functioning.
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I am a care provider for early psychosis at a study site.
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My family member, over 18, is getting early psychosis services at a study site.

EPI-CAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, maximum of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, maximum of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Colorado Symptom Index (CSI) - Symptom severity
DUP Tool convergent validity
DUP Tool feasibility and Acceptability
+6 more
Secondary outcome measures
Provider level factors
Satisfaction with care

EPI-CAL Trial Design

2Treatment groups
Experimental Treatment
Group I: EPI-CAL mHealth data networkExperimental Treatment1 Intervention
This arm of the study involves the use of the mobile health technology ("app") to measure outcomes within an early psychosis (EP) program.
Group II: DUP EvaluationExperimental Treatment1 Intervention
A subset of individuals will participate in interviews to validate a tool to determine the duration of untreated psychosis in community settings

Find a Location

Who is running the clinical trial?

Washington University School of MedicineOTHER
1,931 Previous Clinical Trials
2,298,380 Total Patients Enrolled
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,705,662 Total Patients Enrolled
University of California, San FranciscoOTHER
2,500 Previous Clinical Trials
15,235,142 Total Patients Enrolled

Media Library

First Episode Psychosis Research Study Groups: EPI-CAL mHealth data network, DUP Evaluation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this medical trial below or above 35 years old?

"The age range of individuals that can be enrolled into this experiment is 8 to 40 years."

Answered by AI

Who meets the qualifications to take part in this trial?

"This clinical trial, for which 1329 participants are being recruited, requires that applicants have a psychotic disorder and be aged 8-40 years old."

Answered by AI

Is the enrollment window for this clinical experiment still open?

"Currently, clinicialtrials.gov does not indicate that this trial is open to new participants; the study was initially posted on September 10th 2019 and last modified on May 9th 2022. Nevertheless, there are 422 other studies recruiting patients now."

Answered by AI
~238 spots leftby Apr 2025