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Atypical Antipsychotic

Cariprazine for Adolescent Schizophrenia

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
DSM-5 primary diagnosis of schizophrenia.
PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2).
Must not have
Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 6
Awards & highlights
Pivotal Trial

Summary

This trial will test whether cariprazine is an effective and safe treatment for adolescents with schizophrenia.

Who is the study for?
Adolescents aged 13-17 with a confirmed diagnosis of schizophrenia can join this trial. They must be moderately ill or worse and have certain levels of symptoms like delusions or hallucinations. Those with intellectual disabilities, other psychotic disorders, or recent substance-related issues cannot participate.
What is being tested?
The study is testing the effectiveness and safety of Cariprazine compared to a placebo in treating schizophrenia in teenagers. Participants will randomly receive either the actual drug or a placebo to see if there's an improvement in their condition.
What are the potential side effects?
While not specified here, common side effects for antipsychotic medications like Cariprazine may include drowsiness, restlessness, weight gain, dry mouth, constipation, and sometimes more serious effects such as movement disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with schizophrenia.
Select...
My PANSS score is 70 or more with moderate symptoms in at least 2 areas.
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My schizophrenia diagnosis was confirmed by a clinician using the K-SADS-PL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a specific psychotic or bipolar disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in PANSS total score at Week 6

Side effects data

From 2011 Phase 3 trial • 497 Patients • NCT01058668
17%
Akathisia
11%
Headache
10%
Nausea
10%
Extrapyramidal disorder
10%
Insomnia
9%
Vomiting
9%
Restlessness
5%
Constipation
5%
Dizziness
4%
Dyspepsia
2%
Mania
2%
Diarrhoea
2%
Tremor
1%
Hospitalisation
1%
Aggression
1%
Bipolar disorder
1%
Endometrial cancer
1%
Pulmonary embolism
1%
Bipolar I disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Cariprazine (3-6 mg/Day)
Cariprazine (6-12 mg/Day)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Cariprazine 4.5 mg/dExperimental Treatment1 Intervention
Cariprazine capsules, oral administration, once daily.
Group II: Cariprazine 1.5 mg/dExperimental Treatment1 Intervention
Cariprazine capsules, oral administration, once daily.
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo capsules, oral administration, once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cariprazine
2010
Completed Phase 3
~11050

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,324 Total Patients Enrolled
2 Trials studying Schizophrenia
867 Patients Enrolled for Schizophrenia
Gedeon Richter Plc.Lead Sponsor
11 Previous Clinical Trials
3,346 Total Patients Enrolled
Paul YeungStudy DirectorAllergan

Media Library

Cariprazine (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT03817502 — Phase 3
Schizophrenia Research Study Groups: Cariprazine 1.5 mg/d, Cariprazine 4.5 mg/d, Placebo
Schizophrenia Clinical Trial 2023: Cariprazine Highlights & Side Effects. Trial Name: NCT03817502 — Phase 3
Cariprazine (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03817502 — Phase 3
~19 spots leftby Apr 2025
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