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

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A 52-Week, Multicenter, Open-Label, Flexible-dose Study to Evaluate the Long-term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Subjects With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

ClinicalTrials.gov ID

NCT04578756

Acronym / sponsor ID

3070 Ped OLE / 3070-301-001

Conditions

Schizophrenia, Bipolar I Disorder, Autism Spectrum Disorder (ASD)

Keywords

Schizophrenia, Bipolar I Disorder, Cariprazine, Autism Spectrum Disorder (ASD)

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

310 participants (actual)

Lead sponsor

AbbVieIndustry (pharma, biotech, devices)

Study start

1 Feb 2021 (actual)

Primary completion

6 Oct 2025 (actual)

Study completion

6 Oct 2025 (actual)

First posted

8 Oct 2020 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Non-randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

11

Who may qualify

Ages

5 to 17 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period

   Time frame: Baseline Day 1 to Week 59

   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 Clinically Significant Changes From Baseline in Clinical Laboratory Parameters

   Time frame: Baseline Day 1 to Week 52

   Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.

3. Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters

   Time frame: Baseline Day 1 to Week 59

   Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.

4. Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)

   Time frame: Baseline Day 1 to Week 52

   A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.

5. 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 52

   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".

6. Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)

   Time frame: Baseline Day 1 to Week 52

   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.

7. Change From Baseline in Barnes Akathisia Rating Scale (BARS)

   Time frame: Baseline Day 1 to Week 52

   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]).

8. Change From Baseline in Simpson-Angus Scale (SAS)

   Time frame: Baseline Day 1 to Week 52

   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.

9. Number of Participants With Clinically Significant Changes From Baseline in Opthalmologic Parameters

   Time frame: Baseline Day 1 to Week 52

   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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
• Related InfoLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

42 sites in 2 countries: see every site and its status.