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Atypical Antipsychotic

Brexpiprazole for Schizophrenia With Substance Use Disorder

Phase 4
Waitlist Available
Led By Xiaoduo Fan, MD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial is testing whether a new antipsychotic drug is effective in treating patients with schizophrenia who also have a substance use disorder.

Who is the study for?
This trial is for adults aged 18-65 with schizophrenia or schizoaffective disorder and a substance use disorder involving alcohol, cocaine, heroin, or cannabis. Participants must have been on a stable dose of antipsychotic medication for at least one month and be compliant with outpatient medications. Women who can bear children must use birth control during the study. Exclusions include certain medical conditions, pregnancy, breastfeeding, seizure disorders, and current treatment with specific drugs.Check my eligibility
What is being tested?
The study tests brexpiprazole in patients with co-occurring schizophrenia and substance use disorders against their usual antipsychotic treatments over 12 weeks. Eighty participants will either switch to brexpiprazole or continue their current medication randomly across three US sites.See study design
What are the potential side effects?
Brexpiprazole may cause side effects such as restlessness, weight gain, fatigue, digestive issues like constipation or indigestion; it might also increase blood sugar levels which could affect people with diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time line Follow back (TLFB)
Visual Analog Scale
Secondary outcome measures
Amount of money spent on substances

Side effects data

From 2019 Phase 4 trial • 51 Patients • NCT03149991
16%
Alteration in Taste
16%
Dizziness
12%
Restlessness/Akathisia
8%
Insomnia/Sleep disturbance
8%
Gastric Distress
8%
Constipation
8%
Headache
8%
Sedation
8%
Dissociation/Detachment
4%
Euphoria
4%
Nausea
4%
Elevated alt
4%
Light headedness
4%
Irritability
4%
Irregular/Early Menses
4%
Bi-lateral hand pain
4%
Shakiness
4%
Increased appetite
4%
Hot flashes
4%
Increased salivation post dose
4%
Panic episode
4%
Weight gain
4%
Lethargy
4%
Bruxism
4%
Twitching of left side lower lip
4%
Unsteadiness of gait
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brexpiprazole
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Brexpiprazole 4mg daily for 12 weeks
Group II: Treatment as UsualActive Control1 Intervention
Stay on current antipsychotic medication for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brexpiprazole
2013
Completed Phase 4
~4150

Find a Location

Who is running the clinical trial?

Augusta UniversityOTHER
211 Previous Clinical Trials
85,016 Total Patients Enrolled
Otsuka Pharmaceutical Co., Ltd.Industry Sponsor
203 Previous Clinical Trials
97,807 Total Patients Enrolled
University of Massachusetts, WorcesterLead Sponsor
342 Previous Clinical Trials
976,558 Total Patients Enrolled

Media Library

Brexpiprazole (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT03526354 — Phase 4
Substance Use Disorder Research Study Groups: Experimental, Treatment as Usual
Substance Use Disorder Clinical Trial 2023: Brexpiprazole Highlights & Side Effects. Trial Name: NCT03526354 — Phase 4
Brexpiprazole (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03526354 — Phase 4
Substance Use Disorder Patient Testimony for trial: Trial Name: NCT03526354 — Phase 4

Frequently Asked Questions

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

Does this study accept participants who are older than 35 years?

"Candidates must meet the predetermined age range for consideration, which is 18 to 65 years old."

Answered by AI

Is this investigation currently open to additional participants?

"According to information presented on clinicaltrials.gov, this experiment is still in need of participants and was first posted March 19th 2018 with the most recent update occurring May 31st 2022."

Answered by AI

Has Brexpiprazole been tested in multiple clinical trials?

"Brexpiprazole was initially investigated in 2017 and additional details can be obtained by calling 844-687-8522. The number of completed clinical trials stands at 158, with 9 active studies currently taking place, principally around Chapel Hill in North carolina."

Answered by AI

What are the requirements to qualify for participating in this research program?

"This clinical trial is searching for 80 individuals between 18 and 65 years old who are afflicted by schizophrenia. To be eligible, participants must have consumed at least one of the following substances (cocaine, heroin, cannabis or alcohol) on four days in the past thirty with a minimum use within seven days prior to randomization according to TLFB interview results."

Answered by AI

To what extent has participation in this clinical experiment grown?

"Affirmative. Clinicaltrials.gov reveals that this medical experiment, which commenced on March 19th 2018, is actively seeking applicants. Approximately 80 individuals must be enlisted from 3 distinct sites."

Answered by AI

What potential risks should be taken into consideration when administering Brexpiprazole?

"Based on the Phase 4 status of Brexpiprazole, our team has deemed it to be safe and assigned a score of 3."

Answered by AI

Is this research venture a pioneering effort?

"Research into Brexpiprazole began in 2017 with an initial clinical trial sponsored by H. Lundbeck A/S and involving 315 participants, which ultimately led to the drug's Phase 3 approval. To this day, 9 separate studies are taking place across 14 cities spanning three nations."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
University of North Carolina
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have had horrible side effects from every drug I’ve tried to quit drinking.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder
Xiaoduo Fan 2018. "Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03526354.
~7 spots leftby Apr 2025
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