Adolescent patient (13-17 years of age) with Schizophrenia
Conditions
Interventions
Product Name: cariprazine
Product Code: RGH-188
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Cariprazine HCI
CAS Number: 1083076-69-0
Current Sponsor code: RGH-188
Other descriptive name: C
Sponsors
Gedeon Richter Plc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - In addition to the informed consent given by the parent(s) or legal representative assent of the patient must be obtained for participating in the study prior to any study related procedures - Male or female patients must be 13 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition - Patient has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobaccorelated) within the 3 months before Screening - Patient with acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypothyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease. - Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 antipsychotic trials of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the drug’s package insert). - Patient requires concomitant treatment with moderate or strong cytochrome P450 (CYP) 3A4 inhibitors or inducers. If applicable, these drugs must be discontinued 7 days prior to Baseline (Visit 2). - Patient 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 treatment - Positive UDS for substances of abuse at Screening. Exception: patients with a positive UDS at Screening for opiates, cannabinoids, amphetamines, or benzodiazepines may be allowed in the study provided all 3 of the following apply: o The drug was used for a legitimate medical purpose with the exception of poppy seed consumption; o The drug can be discontinued prior to further participation in the study (except for benzodiazepines which may be continued if the dose [lorazepam up to 2 mg/d or its benzodiazepine equivalent, with the exception of phenazepam] has been stable for at least 1 month prior to Screening or if used as a rescue medication, consistent with section 10.7.2. and 10.7.3 in the protocol.) o A repeat UDS is negative for these substances prior to Baseline (Visit 2), except benzodiazepine use as described above. - Patients who meet any of the following ophthalmological criteria: o A history of cataracts o Any clinically significant ocular trauma or complications of ocular trauma, or history of retinal detachment, intraocular surgery or laser treatment o History of ocular disease (open- or narrow-angle glaucoma, retinopathies, corneal diseases) o History of amiodarone or systemic corticosteroid use for = 3 consecutive months in the past year - For female patients, positive pregnancy test at Screening or nursing or planning a pregnancy at any time during participation in the study. - History of suicide attempt within 6 months of Screening in the judgement of the Investigator. - Current suicidal or homicidal ideation judged clinically significant by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of cariprazine (1.5 mg/d to 6.0 mg/d) in the treatment of adolescents (13 to <18 years of age) with schizophrenia.;Secondary Objective: To assess health-related outcomes during long-term treatment with cariprazine (1.5 mg/d to 6.0 mg/d) in adolescent patients (13-<18 years of age) with schizophrenia. To evaluate the long-term effectiveness of cariprazine (1.5 mg/d to 6.0 mg/d) in the treatment of adolescents (13 to <18 years of age) with schizophrenia.;Primary end point(s): Primary Outcome Measures: adverse events, clinical laboratory assessments including HbA1c, prolactin, FSH and LH, menstrual cycle assessment, vital signs, weight, physical examination, ECG, C-SSRS, CDSS, AIMS, BARS, SAS, UKU and Tanner staging;Timepoint(s) of evaluation of this end point: From baseline to week 104 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Additional Outcome Measures: Effectiveness measures: PANSS, CGI-S, CGI-I, C-GAS, CDR system Health-related outcome measures: CGSQ, PQ-LES-Q;Timepoint(s) of evaluation of this end point: From baseline to week 104 | — |
Countries
Argentina, Bulgaria, Colombia, Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine
Contacts
Public ContactMedicalInformationScientificService
Gedeon Richter Plc
Outcome results
None listed