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Cariprazine Flexible Dose for Schizophrenia

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: Are there any documented dangers associated with Cariprazine Flexible Dose?

Carip<a href="https://www.withpower.com/clinical-trials/ra">ra</a>zine Flexible Dose is a Phase 3 trial medication, meaning that while there is some efficacy data available, there is <a href="https://www.withpower.com/clinical-trials/als">als</a>o extensive safety data from multiple rounds of testing. Our team at Power rates the safety of this medication as a 3.

D&H Tamarac Research Center /ID# 250435, Tamarac, FL

Schizophrenia+2 More ConditionsCariprazine Flexible Dose - Drug

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Eligibility

5 - 17

All Sexes

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

Similar Trials

ABBV-525 Dose Escalation

CVL-231

SAGE-718

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

Similar Trials

ABBV-525 Dose Escalation

CVL-231

SAGE-718

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