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Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia or Bipolar I Disorder

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ClinicalTrials.gov Identifier: NCT04578756
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia or bipolar I disorder, and to establish the benefit-risk profile of long-term treatment in this population.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar I Disorder Drug: Cariprazine Flexible Dose Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 26-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia or Bipolar I Disorder
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : June 4, 2023
Estimated Study Completion Date : June 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Cariprazine Dose 1
Participants with Schizophrenia 13 to 17 years will receive cariprazine.
Drug: Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)

Experimental: Cariprazine Dose 2
Participants with Bipolar I Disorder, 10 to 12 years (weighing <=40 kg) will receive cariprazine.
Drug: Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)

Experimental: Cariprazine Dose 3
Participants with Bipolar I Disorder, 10 to 12 years (weighing >40 kg) will receive cariprazine.
Drug: Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)

Experimental: Cariprazine Dose 4
Participants with Bipolar I Disorder, 13 to 17 years will receive cariprazine.
Drug: Cariprazine Flexible Dose
1 capsule to be taken orally at approximately the same time of day (morning or evening)




Primary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period [ Time Frame: Baseline Day 1 to Week 30 ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.

  2. Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period [ Time Frame: Baseline Day 1 to Week 30 ]
    An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A NEAE is a new AE that occurred during the Safety Follow-up Period.

  3. Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters [ Time Frame: Baseline Day 1 to Week 26 ]
    Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.

  4. Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters [ Time Frame: Baseline Day 1 to Week 30 ]
    Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.

  5. Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG) [ Time Frame: Baseline Day 1 to Week 26 ]
    A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.

  6. Number of Participants With Suicidal Ideation or Suicidal Behavior as Recorded on the Columbia-Suicide Severity Rating (C-SSRS) Scale [ Time Frame: Baseline Day 1 to Week 26 ]
    C-SSRS is a clinician-rated scale that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 "wish to be dead," and 5 "active suicidal ideation with specific plan and intent". Suicidal behavior is classified on a 5-item scale: 0 "no suicidal behavior, and 4 "actual attempt".

  7. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score (Participants With Schizohrenia Only) [ Time Frame: Baseline Day 1 to Week 26 ]
    The Calgary Depression Scale (CDSS) is a 9-item scale specifically developed for the assessment of depression in participants with schizophrenia. All items are rated on a 4-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe.

  8. Change From Baseline in Children's Depression Rating Scale - Revised (CDRS-R) (Participants with Bipolar I Disorder Only) [ Time Frame: Baseline Day 1 to Week 26 ]
    CDRS-R is a 17-item, clinician-administered scale specifically developed for the assessment of depressive symptoms in pediatric participants.

  9. Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline Day 1 to Week 26 ]
    AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.

  10. Change From Baseline in Barnes Akathisia Rating Scale (BARS) [ Time Frame: Baseline Day 1 to Week 26 ]
    BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal [0] to severe [3]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent [0] to severe akathisia [5]).

  11. Change From Baseline in Simpson-Angus Scale (SAS) [ Time Frame: Baseline Day 1 to Week 26 ]
    SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.

  12. Number of Participants With Clinically Significant Changes From Baseline in Opthalmologic Parameters [ Time Frame: Baseline Day 1 to Week 26 ]
    Ocular examination parameters included Intraocular pressure (IOP) measurement, Best-corrected visual acuity (BCVA), color fundus photography, color vision testing using Hardy Rand and Rittler (HRR) plates, and assessment of Optical coherence tomography (OCT) and cataracts. The investigator assessed the results for clinical significance.

  13. Number of Participants With Menstrual Onset Shift (Female Participants Only) [ Time Frame: Baseline Day 1 to Week 26 ]
    Female participants who have entered menarche will be asked for the date of the first day of their most recent menstrual period.

  14. Incidence of Participants Shifting in Tanner Staging [ Time Frame: Baseline Day 1 to Week 26 ]
    Tanner staging is a scale for assessing physical development in children, adolescents, and adults. The scale defines physical measurements of development based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of schizophrenia or bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
  • Participant must have normal physical examination findings, clinical laboratory test results, and ECG results at Screening Visit 1, or from the last visit of respective lead-in study, or abnormal results that are determined to be not clinically significant by the investigator.
  • Negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test (all female participants).
  • Participants (if reached his spermarche or her menarche) and is sexually active, must agree to sexual abstinence or to use an approved birth control method for the full duration of participation in the study. The investigator and each participant will determine the appropriate method of contraception for the participant during their participation in the study.
  • Parent(s) or participant's legal representative(s) must be capable of giving signed Informed Consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol as explained by the investigator. Written informed consent from the Parent(s) or participant's legal representative(s) must be obtained prior to any study-related procedures.
  • Informed assent (unless local regulations require consent) must be obtained for all participants before eligibility evaluation for enrollment in the study.

    • For 10-11-year-old participants, a different assent form will be used than that for 12-17-year-old participants.
  • Participant must have a caregiver (parent or legally authorized representative) who is willing and able to be responsible for safety monitoring of the participant, provide information about the participant's condition, oversee administration of study intervention, and accompany the participant to all study visits.
  • Participant must be able to swallow the study intervention.

Exclusion Criteria:

  • Participants with DSM-5 diagnosis of schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition.
  • DSM-5 diagnosis of intellectual disability (IQ < 70).
  • Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Screening (Visit 1) of the respective lead-in study, and/or within the 3 months before Visit 1 of this open-label (OL) study.
  • Participant with an acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypo-thyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease.
  • Severe head trauma.
  • History of seizures, with the exception of febrile seizures.
  • History of tumor of the central nervous system.
  • Participant requires concomitant treatment with strong CYP3A4 inhibitors or CYP3A4 inducers. If applicable, these drugs must be discontinued 7 days prior to Baseline (Visit 2).
  • Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component, with the exception of permitted interventions.
  • Use of an antipsychotic depot within 2 cycles of their respective dosing interval prior to Screening (Visit 1).
  • Participant requires initiation or termination of psychotherapy within the 3 months preceding Screening (Visit 1), or plans to initiate, terminate, or change any outpatient psychotherapy during the course of the study.
  • ECT within 1 month of Screening (Visit 1).
  • Participant is unwilling to discontinue or, in the opinion of the investigator, unable to safely taper off any protocol-specified prohibited treatment prior to the Baseline (Visit 2) without significant destabilization or increased suicidality.
  • Participant is currently enrolled in another investigational drug or device study or participation in such a study within 3 months of Baseline (Visit 2).
  • Known history of human immunodeficiency virus infection.
  • Female participant who entered menarche and is sexually active, and with any of the following at Screening (Visit 1): positive pregnancy test, nursing, or planning to become pregnant at any time during participation in the study.
  • Known allergy or sensitivity to the study intervention or its components.
  • History of serious homicidal risk or behavior that resulted in hospitalization or adjudication (legal sentencing) within 6 months of Screening (Visit 1).
  • History of suicide attempt within 6 months of Screening (Visit 1) in the judgment of the investigator.
  • The participant has a condition or is in a situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
  • Current suicidal or homicidal ideation in the judgment of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578756


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: ALLERGAN INC. Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04578756    
Other Study ID Numbers: 3070-301-001
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing, please refer to the link below
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Allergan:
Schizophrenia
Bipolar I Disorder
Cariprazine
Additional relevant MeSH terms:
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Disease
Schizophrenia
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cariprazine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs