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Atypical Antipsychotic
Cariprazine for Bipolar Disorder in Youth
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
Study Summary
This trial is to study the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population.
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.Check my eligibility
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.See study design
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 belowSelect...
I have experienced at least one manic episode in my life.
Select...
My mood scores are low, showing I'm not in a manic state.
Select...
I am between 10 and 17 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a specific mental health condition like schizophrenia or PTSD.
Select...
You have experienced four or more episodes of mood changes in the past year.
Select...
I have a history of significant head trauma, brain tumors, or conditions that could cause seizures.
Timeline
Screening ~ 3 days1 visit
Treatment ~ Varies
Follow Up ~ 3 days1 visit
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abnormal Change from Baseline in Vital Signs
Change in Children's Depression Rating Scale - Revised (CDRS-S) Total Score
Change in Electrocardiogram (ECG)
+2 moreSide effects data
From 2011 Phase 3 trial • 497 Patients • NCT0105866817%
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%
Aggression
1%
Bipolar disorder
1%
Hospitalisation
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)
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
276,189 Total Patients Enrolled
AbbVieLead Sponsor
963 Previous Clinical Trials
502,933 Total Patients Enrolled
1 Trials studying Bipolar Disorder
64 Patients Enrolled for Bipolar Disorder
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,879 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My mood scores are low, showing I'm not in a manic state.I am between 10 and 17 years old.My mood disorder symptoms are mild, based on recent assessments.You have experienced serotonin syndrome or neuroleptic malignant syndrome in the past.You have experienced four or more episodes of mood changes in the past year.I have been diagnosed with a specific mental health condition like schizophrenia or PTSD.You have experienced at least one episode of extreme mood elevation, called mania, at any point in your life.I have a history of significant head trauma, brain tumors, or conditions that could cause seizures.I have experienced at least one manic episode in my life.My current depressive episode has lasted more than 4 weeks but less than a year.My current depressive episode has lasted more than 4 weeks but less than a year.The patient had a CGI-S scale score of > = 4 (moderately ill) at Visit 1 and Visit 2.My mood disorder symptoms are mild, based on recent assessments.My current depressive episode has lasted more than 4 weeks but less than a year.I have had seizures, but not from fever.The CDRS-R score was greater than or equal to 45 at both Visit 1 and Visit 2.You are moderately ill according to the doctor's evaluation at two different visits.I have experienced at least one manic episode in my life.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Cariprazine
Awards:
This trial has 1 awards, including:- 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: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Bipolar Disorder Patient Testimony for trial: Trial Name: NCT04777357 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research study something new and innovative?
"Cariprazine has been researched since 2019, when the first study was conducted by Allergan. This initial study had 330 participants. Cariprazine received Phase 3 drug approval after this first study. As of now, there are 8 active studies involving Cariprazine being conducted in 58 cities and 12 countries."
Answered by AI
To whom is this research project available?
"Eligible participants for this research study must be minors that suffer from depression. The ideal age range is 10 to 17 years old. Currently, there are 380 patients enrolled in the trial."
Answered by AI
What other research studies have there been with Cariprazine?
"There are 8 ongoing studies and 5 in Phase 3 for Cariprazine. Most of these studies are based in Nis, New york, but there are a total of 189 research sites for Cariprazine across the world."
Answered by AI
Could you please elaborate on Cariprazine's safety profile?
"Cariprazine safety is supported by efficacy data from Phase 3 trials, and thus it received a score of 3."
Answered by AI
If a person is over 45, do they still qualify for this research project?
"This particular trial is for pediatric patients aged 10-17, but there are 419 other clinical trials for patients under 18 years old and 1474 for patients over 65."
Answered by AI
Are we looking for more volunteers for this experiment?
"That is correct, the trial is currently recruiting participants. The study was posted on 4/28/2021 and was most recently edited on 11/1/2022. They are looking for 380 participants from 38 different locations."
Answered by AI
Are there other facilities in the city that are also testing this treatment?
"Currently, there are 38 clinical trial sites for this study. To make it more convenient for patients, these 38 sites are located in Upland, Dallas, Avon Lake, and other locations."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
Florida
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Advanced Research Institute of Miami /ID# 228222
The Kennedy Krieger Institute /ID# 226509
Med Clinical Research Partners LLC /ID# 240773
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
2
Why did patients apply to this trial?
to find treatment. I just want to be normal. I'd absolutely love to feel better.
PatientReceived no prior treatments
trying to find a drug to work for my bipolar. To further find a solution to my Mental health issues.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
When can I start this trial? How many visits would I have to make?
PatientReceived 1 prior treatment
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