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Atypical Antipsychotic

Cariprazine for Bipolar Disorder in Youth (3112 Ped BPD 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
Participant has a lifetime history of at least one manic episode.
Young-Mania Rating Scale (YMRS) score <= 12 with YMRS Item 1 (elevated mood) score <= 2 at Visit 1 and Visit 2.
Must not have
Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder.
Four or more episodes of a mood disturbance within the 12 months before Visit 1.
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights
Pivotal Trial

Summary

This trial is testing the safety and effectiveness of Cariprazine for treating depressive episodes in children and teenagers with bipolar I disorder. The goal is to find out if Cariprazine can help young people with this condition. Cariprazine is an atypical antipsychotic recently approved for the treatment of depressive episodes in adults with bipolar I disorder.

Who is the study for?
This trial is for kids aged 10-17 with Bipolar I Disorder who've had at least one manic episode and are currently in a depressive phase lasting more than 4 weeks but less than a year. They should have moderate illness severity according to specific medical scales. Kids with certain psychiatric conditions, history of seizures (except febrile seizures), or significant brain trauma can't join.
What is being tested?
The study tests Cariprazine against a placebo to see if it helps with depression in young people with Bipolar I Disorder. Participants will be randomly assigned to either the drug or placebo group and doses may change based on their response after three weeks. The treatment's effects are monitored through regular visits, blood tests, side effect checks, and questionnaires.
What are the potential side effects?
While not specified here, common side effects of Cariprazine in adults include digestive issues, sleepiness or insomnia, dizziness, restlessness and potential increase in weight. Children might experience similar side effects; however this will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have experienced at least one manic episode in my life.
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My mood scores are low, showing I'm not in a manic state.
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I am between 10 and 17 years old.

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 mental health condition like schizophrenia or PTSD.
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You have experienced four or more episodes of mood changes in the past year.
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I have a history of significant head trauma, brain tumors, or conditions that could cause seizures.

Timeline

Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Abnormal Change from Baseline in Vital Signs
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
+6 more

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%
Endometrial cancer
1%
Hospitalisation
1%
Aggression
1%
Bipolar disorder
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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CariprazineExperimental Treatment1 Intervention
Participants will receive flexible dose Cariprazine over a 6 week treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive Placebo over a 6 week treatment period.
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
276,305 Total Patients Enrolled
10 Trials studying Depression
3,739 Patients Enrolled for Depression
AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,199 Total Patients Enrolled
6 Trials studying Depression
2,992 Patients Enrolled for Depression
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,195 Total Patients Enrolled
3 Trials studying Depression
2,412 Patients Enrolled for Depression
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
163,984 Total Patients Enrolled
4 Trials studying Depression
2,182 Patients Enrolled for Depression

Media Library

Cariprazine (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT04777357 — Phase 3
Depression Research Study Groups: Placebo, Cariprazine
Depression Clinical Trial 2023: Cariprazine Highlights & Side Effects. Trial Name: NCT04777357 — Phase 3
Cariprazine (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04777357 — Phase 3
Depression Patient Testimony for trial: Trial Name: NCT04777357 — Phase 3
~141 spots leftby Mar 2027
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