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Coordinated Specialty Care for Psychosis (AC-EPINET Trial)

N/A

Recruiting

Led By Alan Breier

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between 16 and 35 years of age

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

AC-EPINET Trial Summary

This trial will compare the effects of two types of cancer support services on engagement and outcomes.

Who is the study for?

This trial is for young individuals aged 16-35 who have recently been diagnosed with certain mental health conditions, including schizophrenia and bipolar disorder with psychotic features. Participants must be new to one of the six clinical programs, able to consent, and commit to the study schedule.Check my eligibility

What is being tested?

The study compares two ways of delivering Coordinated Specialty Care (CSC) for mental health: through telehealth (CSC-TH) versus standard in-clinic care (CSC-SD). The goal is to see which method keeps patients more engaged over a year.See study design

What are the potential side effects?

Since this trial focuses on service delivery methods rather than medication, side effects are not typical as seen with drug trials. However, participants may experience varying levels of comfort or satisfaction with the mode of therapy they receive.

AC-EPINET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 16 and 35 years old.

AC-EPINET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Annualized hospitalization rates

Secondary outcome measures

Number of participants hospitalized

Symptom and functioning outcomes assessed by the MIRECC-GAF

Time (days) to first hospitalization

AC-EPINET Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CSC-THExperimental Treatment1 Intervention

Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.

Group II: CSC-SDPlacebo Group1 Intervention

Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterOTHER

838 Previous Clinical Trials

518,387 Total Patients Enrolled

1 Trials studying Bipolar Disorder

65 Patients Enrolled for Bipolar Disorder

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,121 Total Patients Enrolled

1 Trials studying Bipolar Disorder

46 Patients Enrolled for Bipolar Disorder

Ohio State UniversityOTHER

829 Previous Clinical Trials

505,455 Total Patients Enrolled

1 Trials studying Bipolar Disorder

30 Patients Enrolled for Bipolar Disorder

Media Library

Coordinated Specialty Care (CSC) Clinical Trial Eligibility Overview. Trial Name: NCT04497857 — N/A

Bipolar Disorder Research Study Groups: CSC-SD, CSC-TH

Bipolar Disorder Clinical Trial 2023: Coordinated Specialty Care (CSC) Highlights & Side Effects. Trial Name: NCT04497857 — N/A

Coordinated Specialty Care (CSC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04497857 — N/A

Frequently Asked Questions

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

At what number of sites is this research endeavor being conducted?

"The ongoing clinical trial is currently recruiting from 6 locations, which span the cities of Chicago, Nashville and Ann Arbor. To minimize travel requirements for those who join the study, it is advisable to select the closest site available."

Answered by AI

Does this clinical study permit individuals above the age of 25 to join?

"The requirements for joining this clinical trial stipulate that the lower age limit is 16 and upper age bound is 35."

Answered by AI

Who is eligible to join this research project?

"This clinical trial aims to enrol 180 participants of the age range 16-35 with schizophrenia. To be eligible, individuals must satisfy certain preconditions such as being capable of offering informed consent, adhering to the study schedule and having a diagnosis in either non-affective or affective psychotic disorders within 5 years of registration."

Answered by AI

What is the total number of participants in this clinical investigation?

"Affirmative. Clinicaltrials.gov indicates that this experiment, which was first advertised on March 16th 2022, is presently in need of volunteers. 180 participants must be found from 6 distinct locations to complete the trial's requirements."

Answered by AI

Are there still openings for participants in this trial?

"Affirmative. Information available on clinicaltrials.gov indicates that this particular trial, first published on March 16th 2022, is currently enrolling participants. 180 patients must be recruited across 6 sites in total."

Answered by AI

Who else is applying?

What state do they live in?

Illinois

Michigan

What site did they apply to?

Prevention and Recovery Center for Early Psychosis

Recovery from Early Psychosis Program (REPP) - Northwestern University

Other

Program for Risk Evaluation and Prevention (PREP) - University of Michigan

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I am a sufferer of bipolar disorder with severe depression and am currently experiencing suicidal ideation.

PatientReceived no prior treatments

I've been on almost every antidepressant there is out there and I am still dealing with depression and no motivation or drive to want to do anything.

PatientReceived no prior treatments

I am hoping to find some medication to finally help me & my mood disorder. I have tried multiple other options over the years but without much luck of controlling the depression or mania.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Academic-Community EPINET (AC-EPINET)

Alan Breier 2022. "Academic-Community EPINET (AC-EPINET)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04497857.

All > Mental Illness > Schizophrenia