Schizophrenia MedDRA version: 15.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Aripiprazole
Product Code: OPC-14597, Lu AF41155
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: ARIPIPRAZOLE
CAS Number: 129722-12-9
Concentration unit: mg
Sponsors
Otsuka Pharmaceutical Development & Commercialization,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects 18 to 66 years of age, inclusive, at the time of informed consent. 2. Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures. 3. Ability, in the opinion of the investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales. 4. Subjects who have met the completion criteria in the 31-12-291 registrational trial for the acute treatment of adults with schizophrenia. 5. Subjects who, in the investigator’s judgment, require chronic treatment with antipsychotic medication and would benefit from extended treatment with an IM depot formulation. 6. Outpatient status at the Week 12 visit in Trial 291. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 124 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1. Sexually active males of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 180 days after the last dose of trial medication. Sexually active WOCBP who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 150 days after the last dose of trial medication. 2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP in this trial. 3. Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator’s opinion, that requires treatment with an antidepressant. 4. Subjects who are anticipated needing CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the course of the trial. 5. Subjects with a significant risk of violent behavior; who represent a risk of committing suicide; or who in the clinical judgment of the investigator present a serious risk of suicide. 6. Subjects requiring any antipsychotic(s) other than aripiprazole IM depot after completion of Trial 291. 7. Subjects likely to require prohibited concomitant therapy during the trial 8. Laboratory test and ECG results which are exclusionary 9.Any subject who, in the opinion of the investigator or medical monitor, should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this open-label trial is to evaluate the safety and tolerability of aripiprazole intramuscular (IM) depot administered for 26 weeks to subjects with schizophrenia.;Secondary Objective: none;Primary end point(s): ? Frequency and severity of AEs, serious AEs (clinical and laboratory), and discontinuations from the trial due to AEs. ;Timepoint(s) of evaluation of this end point: The assessment of AEs will be monitored and recorded by the Physician at each visit every four weeks including a 26 week follow up phone call. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Suicide risk as assessed and classified by the C-SSRS. ? Extrapyramidal symptoms evaluated using the Simpson Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), and Barnes Akathisia Rating Scale (BARS). ? Vital signs, laboratory tests, ECG parameters, body weight, and physical examination findings.;Timepoint(s) of evaluation of this end point: Suicidality will be monitored throughout the trial using the C-SSRS at every visit. Extrapyramidal Syptoms will be evaluated By SAS, AIMS and BARS at week 12 and week 24 visits. Vital Signs will be monitored and recorded by the Physician at each visit every four weeks. Lab test, ECG, Body weight will be measured at week 12 and week 24 visits. | — |
Countries
Bulgaria, Colombia, Croatia, Egypt, Indonesia, Latvia, Malaysia, Mexico, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, Turkey, Ukraine, United States
Contacts
Public ContactPamela Perry
Otsuka Pharmaceutical Development & Commercialization,
Outcome results
None listed