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Atypical Antipsychotic

Aripiprazole Once-Monthly vs Oral Antipsychotics for Schizophrenia

Phase 4
Waitlist Available
Led By Matt Byerly, MD
Research Sponsored by Matt Byerly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female subjects who are surgically sterile or agree to specific birth control measures
Aged 18 to 60 years at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization up to 3 months
Awards & highlights

Study Summary

This trial compares an injection of aripiprazole once-monthly to standard care oral antipsychotics for non-adherent outpatients with schizophrenia. The goal is to see which treatment helps people take their medicine more regularly and have more positive outcomes.

Who is the study for?
This trial is for outpatients aged 18-60 with schizophrenia, who have been on a single oral antipsychotic for at least 3 months. Participants must not be resistant to treatments or taking multiple antipsychotics, and should not have other major psychiatric diagnoses or unstable medical conditions. They must agree to specific birth control measures if applicable.Check my eligibility
What is being tested?
The study tests whether a once-monthly injection of Aripiprazole helps patients with schizophrenia take their medication more consistently compared to those on standard oral antipsychotics like risperidone or quetiapine. The goal is better adherence and outcomes over three months.See study design
What are the potential side effects?
Aripiprazole may cause side effects such as restlessness, headaches, dizziness, insomnia, constipation, anxiety and possible weight gain. Standard oral antipsychotics can also cause drowsiness, weight gain, dry mouth, blurred vision and muscle stiffness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am either surgically sterile or agree to use birth control.
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I am between 18 and 60 years old.
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I have been diagnosed with schizophrenia for at least 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization up to 3 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
Syndrome
Secondary outcome measures
Cognition
Efficacy: PANSS total score overall - symptom severity
Quality of Life
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Aripiprazole Once-MonthlyExperimental Treatment1 Intervention
Switch to 400 mg aripiprazole once-monthly injection
Group II: Standard of CareActive Control1 Intervention
Continue current SOC oral antipsychotic medication

Find a Location

Who is running the clinical trial?

Matt ByerlyLead Sponsor
Otsuka America PharmaceuticalIndustry Sponsor
66 Previous Clinical Trials
28,243 Total Patients Enrolled
17 Trials studying Schizophrenia
6,140 Patients Enrolled for Schizophrenia
Matt Byerly, MDPrincipal InvestigatorUT Southwestern Medical Center

Media Library

Schizophrenia Research Study Groups: Aripiprazole Once-Monthly, Standard of Care
Schizophrenia Clinical Trial 2023: Aripiprazole Once-Monthly Highlights & Side Effects. Trial Name: NCT02282085 — Phase 4
Aripiprazole Once-Monthly (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02282085 — Phase 4

Frequently Asked Questions

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

What adverse effects may result from the utilization of Aripiprazole Once-Monthly?

"The risk profile of Aripiprazole Once-Monthly is rated at 3, as this medication has received FDA approval and entered Phase 4 trials."

Answered by AI

Are there any open recruitment opportunities for this clinical trial?

"The information on clinicaltrials.gov implies that this trial is no longer actively recruiting for participants, as the last update was made back in June of 2015; however, there are 388 other medical trials seeking volunteers at present."

Answered by AI

Is the enrollment of elderly individuals encouraged in this medical trial?

"The age requirements for enrolment in this trial are 18 to 60. Meanwhile, there are 55 clinical trials that accept patients under the legal threshold and 199 studies open to elderly individuals above 65 years of age."

Answered by AI

Who is eligible to participate in this clinical research endeavor?

"This trial is recruiting two-hundred participants aged 18 to 60 with a current diagnosis of schizophrenia that has been present for at least six months. The inclusion criteria requires they are able to provide written informed consent, understand the nature and requirements of the study, read and comprehend text in order to complete assessments scales, have been prescribed a single oral antipsychotic medication for three months prior to screening, and comply with birth control regulations if applicable."

Answered by AI

Are there any preceding investigations of the efficacy of Aripiprazole Once-Monthly?

"Currently, 54 clinical trials examining Aripiprazole Once-Monthly are underway. Of these active studies, 15 have progressed to Phase 3. Toronto is the primary research locus for this particular treatment; however, there are 1271 other locations conducting investigations on its efficacy and safety."

Answered by AI

What medical benefits does Aripiprazole Once-Monthly typically provide?

"Aripiprazole Once-Monthly is commonly utilized to mitigate irritability. It can also be a viable treatment option for post traumatic stress disorder (PTSD), dementia, and Alzheimer's disease."

Answered by AI

How many individuals are engaged in this medical study?

"Unfortunately, this clinical trial is not open to recruitment at the moment. The listing was first published on December 1st 2014 and last modified on June 3rd 2015. However, there are 334 trials actively looking for people with schizophrenia and 54 studies welcoming individuals taking Aripiprazole Once-Monthly as part of their treatment regimen."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+

What questions have other patients asked about this trial?

What the process to qualify?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

The medicine I’m taking isn’t working. I've tried several drugs and my current drug doesn't work 100%. I still have problems. I'd like to be part of your trial so I can possibly find relief.
PatientReceived 1 prior treatment
~19 spots leftby Apr 2025