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Atypical Antipsychotic
Cariprazine for Pediatric Schizophrenia
Verified Trial
Phase 3
Recruiting
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is the patient between the ages of 5 - 17 years old?
Is the patient willing to take the study medication daily and undergo study procedures such as EKGs, blood draws, physical, and eye exam?
Must not have
Has the patient been hospitalized for a psychiatric reason within the past 6 months?
Is the patient currently diagnosed with major depressive disorder, schizoaffective disorder, or a substance use disorder?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline day 1 to week 82
Awards & highlights
Study Summary
This trial will study the long-term effects of cariprazine on children with schizophrenia, bipolar disorder, or autism.
Who is the study for?
This trial is for children and teens with schizophrenia, bipolar I disorder, or autism spectrum disorder. They must be able to swallow pills, have normal health check results or non-serious irregularities, and if sexually active, agree to use birth control. A caregiver must oversee their treatment and give informed consent.Check my eligibility
What is being tested?
The study tests the long-term safety of Cariprazine in young patients with certain mental health conditions. It aims to understand the risks and benefits of extended use by observing participants over time as they take varying doses of this medication.See study design
What are the potential side effects?
While not explicitly listed here, common side effects for antipsychotic drugs like Cariprazine may include drowsiness, restlessness, weight gain, dry mouth, blurred vision and gastrointestinal issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 5 and 17 years old.
Select...
I am willing to take daily medication and undergo required tests for the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline day 1 to week 82
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline day 1 to week 82
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
Change From Baseline in Simpson-Angus Scale (SAS)
+8 moreTrial Design
11Treatment groups
Experimental Treatment
Group I: Cariprazine Dose 9Experimental Treatment1 Intervention
Participants with Autism Spectrum Disorder (age 10 to 12 years and >=40 kg body weight) will receive cariprazine.
Group II: Cariprazine Dose 8Experimental Treatment1 Intervention
Participants with Autism Spectrum Disorder (age 10 to 12 years and <40 kg weight) will receive cariprazine.
Group III: Cariprazine Dose 7Experimental Treatment1 Intervention
Participants with Autism Spectrum Disorder ( age 5 to 9 years) will receive cariprazine.
Group IV: Cariprazine Dose 6Experimental Treatment1 Intervention
Participants with Bipolar I Disorder (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.
Group V: Cariprazine Dose 5Experimental Treatment1 Intervention
Participants with Bipolar I Disorder (age 13 to 17 years and < 40 kg body weight) will receive cariprazine.
Group VI: Cariprazine Dose 4Experimental Treatment1 Intervention
Participants with Bipolar I Disorder (age 10 to 12 years and >= 40 kg body weight) will receive cariprazine.
Group VII: Cariprazine Dose 3Experimental Treatment1 Intervention
Participants with Bipolar I Disorder (age 10 to 12 years and <40 kg body weight) will receive cariprazine.
Group VIII: Cariprazine Dose 2Experimental Treatment1 Intervention
Participants with Schizophrenia (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.
Group IX: Cariprazine Dose 11Experimental Treatment1 Intervention
Participants with Autism Spectrum Disorder (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.
Group X: Cariprazine Dose 10Experimental Treatment1 Intervention
Participants with Autism Spectrum Disorder (age 13 to 17 years and <40 kg weight) will receive cariprazine.
Group XI: Cariprazine Dose 1Experimental Treatment1 Intervention
Participants with Schizophrenia (age 13 to 17 years and < 40 kg body weight) will receive cariprazine.
Find a Location
Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
276,289 Total Patients Enrolled
2 Trials studying Schizophrenia
917 Patients Enrolled for Schizophrenia
AbbVieLead Sponsor
958 Previous Clinical Trials
502,110 Total Patients Enrolled
4 Trials studying Schizophrenia
1,186 Patients Enrolled for Schizophrenia
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,829 Total Patients Enrolled
1 Trials studying Schizophrenia
250 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with schizophrenia, bipolar I, or autism.A negative serum β-hCG pregnancy test in women aged 18 years or older.I am willing to take daily medication and undergo required tests for the study.You are sexually active, must agree to sexual abstinence or to use an approved birth control method for the full duration of participation in the studyI am between 5 and 17 years old.I can swallow pills.I or my legal guardian can sign and follow the study's consent form.Informed consent must be obtained for all participants before enrollment in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cariprazine Dose 7
- Group 2: Cariprazine Dose 9
- Group 3: Cariprazine Dose 10
- Group 4: Cariprazine Dose 11
- Group 5: Cariprazine Dose 8
- Group 6: Cariprazine Dose 1
- Group 7: Cariprazine Dose 6
- Group 8: Cariprazine Dose 5
- Group 9: Cariprazine Dose 3
- Group 10: Cariprazine Dose 4
- Group 11: Cariprazine Dose 2
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What else do we know about Cariprazine Flexible Dose from other research?
"At the moment, there are 8 different clinical trials researching Cariprazine Flexible Dose. Out of these 8 trials, 5 are in Phase 3. Additionally, these trials are taking place in 189 different locations, with most of them in Bogotá and Texas."
Answered by AI
Is this a clinical trial that is testing an innovative new treatment?
"Cariprazine Flexible Dose has been part of medical research since 2019, when the first Phase 3 trial was sponsored by Allergan. There are currently 8 active trials being conducted in 58 different cities across 12 countries."
Answered by AI
If an elderly person is not as healthy as they used to be, can they still participate in this research project?
"This research is currently enrolling pediatric patients that are between 10 to 17 years old."
Answered by AI
Are we still looking for test participants for this experiment?
"This study, which is currently recruiting patients, was first posted on February 1, 2021 and was last updated on August 24, 2022."
Answered by AI
Could you tell me how many different hospitals in North America are taking part in this clinical trial?
"University of Virginia /ID# 236362 in Charlottesville, Houston Clinical Trials /ID# 234444 in Bellaire, and Links Clinical Trials /ID# 240975 in Miami are some of the 34 locations where this study is currently taking place."
Answered by AI
Are there any documented dangers associated with Cariprazine Flexible Dose?
"Cariprazine Flexible Dose is a Phase 3 trial medication, meaning that while there is some efficacy data available, there is also extensive safety data from multiple rounds of testing. Our team at Power rates the safety of this medication as a 3."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Florida
Texas
How old are they?
< 18
What site did they apply to?
Red Oak Psychiatry Associates /ID# 236602
McGovern Medical School /ID# 238506
Houston Clinical Trials /ID# 234444
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
looking for a medication that improve autism symptoms.
PatientReceived 1 prior treatment
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