Cariprazine Flexible Dose for Schizophrenia

D&H Tamarac Research Center /ID# 250435, Tamarac, FL
Schizophrenia+2 More ConditionsCariprazine Flexible Dose - Drug
Eligibility
5 - 17
All Sexes

Study Summary

This trial will study the long-term effects of cariprazine on children with schizophrenia, bipolar disorder, or autism.

Eligible Conditions
  • Schizophrenia
  • Autism Spectrum Disorder
  • Bipolar Disorder

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

14 Primary · 0 Secondary · Reporting Duration: Baseline Day 1 to Week 30

Week 26
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score (Participants With Schizohrenia Only)
Change From Baseline in Children's Depression Rating Scale - Revised (CDRS-R) (Participants with Bipolar I Disorder Only)
Change From Baseline in Simpson-Angus Scale (SAS)
Incidence of Participants Shifting in Tanner Staging
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
Number of Participants With Clinically Significant Changes From Baseline in Opthalmologic Parameters
Number of Participants With Menstrual Onset Shift (Female Participants Only)
Number of Participants With Suicidal Ideation or Suicidal Behavior as Recorded on the Columbia-Suicide Severity Rating (C-SSRS) Scale
Week 30
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period
Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

8 Treatment Groups

Cariprazine Dose 8
1 of 8
Cariprazine Dose 1
1 of 8
Cariprazine Dose 7
1 of 8
Cariprazine Dose 6
1 of 8
Cariprazine Dose 5
1 of 8
Cariprazine Dose 3
1 of 8
Cariprazine Dose 4
1 of 8
Cariprazine Dose 2
1 of 8

Experimental Treatment

200 Total Participants · 8 Treatment Groups

Primary Treatment: Cariprazine Flexible Dose · No Placebo Group · Phase 3

Cariprazine Dose 8
Drug
Experimental Group · 1 Intervention: Cariprazine Flexible Dose · Intervention Types: Drug
Cariprazine Dose 1
Drug
Experimental Group · 1 Intervention: Cariprazine Flexible Dose · Intervention Types: Drug
Cariprazine Dose 7
Drug
Experimental Group · 1 Intervention: Cariprazine Flexible Dose · Intervention Types: Drug
Cariprazine Dose 6
Drug
Experimental Group · 1 Intervention: Cariprazine Flexible Dose · Intervention Types: Drug
Cariprazine Dose 5
Drug
Experimental Group · 1 Intervention: Cariprazine Flexible Dose · Intervention Types: Drug
Cariprazine Dose 3
Drug
Experimental Group · 1 Intervention: Cariprazine Flexible Dose · Intervention Types: Drug
Cariprazine Dose 4
Drug
Experimental Group · 1 Intervention: Cariprazine Flexible Dose · Intervention Types: Drug
Cariprazine Dose 2
Drug
Experimental Group · 1 Intervention: Cariprazine Flexible Dose · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline day 1 to week 30

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
275,627 Total Patients Enrolled
2 Trials studying Schizophrenia
917 Patients Enrolled for Schizophrenia
AbbVieLead Sponsor
873 Previous Clinical Trials
479,810 Total Patients Enrolled
4 Trials studying Schizophrenia
1,338 Patients Enrolled for Schizophrenia
ABBVIE INC.Study DirectorAbbVie
325 Previous Clinical Trials
125,002 Total Patients Enrolled
1 Trials studying Schizophrenia
402 Patients Enrolled for Schizophrenia
ALLERGAN INC.Study DirectorAllergan
74 Previous Clinical Trials
78,120 Total Patients Enrolled

Eligibility Criteria

Age 5 - 17 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be able to swallow the study medication.

Who else is applying?

What state do they live in?
Florida33.3%
Illinois33.3%
Texas33.3%
How old are they?
< 18100.0%
What site did they apply to?
Alliance Research /ID# 23626133.3%
Sarkis Clinical Trials /ID# 23689333.3%
McGovern Medical School /ID# 23850633.3%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%
How many prior treatments have patients received?
1100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.