Schizophrenia MedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Aripiprazole
Product Code: OPC-14597
Pharmaceutical Form: Lyophilisate for suspension for injection
INN or Proposed INN: ARIPIPRAZOLE
CAS Number: 129722-12-9
Concentration unit: mg milli
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who are able to provide written informed consent. If the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requires consent by a legally acceptable representative (LAR) in addition to the subject, all required consents must be obtained prior to the initiation of any protocol-required procedure. 2) Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent. 3) Subjects with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a history of the illness for at least 1 year (12 months) prior to screening from a reliable source (eg, subject, family member, friend, caregiver, healthcare provider, or medical records). 4) Subjects who in the investigator’s judgment would benefit from extended treatment with a long-acting injectable formulation. 5) Subjects who will be able to produce at least 7 months retrospective data by records or a reliable source, pertaining to all hospitalizations and interventions (psychiatric and nonpsychiatric). 6) Subjects who have at least 1 inpatient psychiatric hospitalization in the 2 years (24 months) prior to screening, but have been managed as outpatients for the 4 weeks prior to signing the ICF and for the full duration of the screening period. 7) Subjects must have been on oral antipsychotic treatment for the full 7 months prior to the screening phase. 8) Subjects who showed response to antipsychotic treatment (other than clozapine), according to the investigator’s opinion. 9) In the investigator’s opinion, subjects who are able to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, aripiprazole IM depot injection, and discontinuation of prohibited concomitant medications; who can read and understand the written word in order to complete subject-reported outcomes measures; and who can be reliably rated on assessment scales. 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 600 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or have been incarcerated in the past 7 months for any reason must not be enrolled into this trial. 2) Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the trial. 3) Any subject who requires or may need any other antipsychotic medications during the course of the trial, other than allowed rescue medication. 4) Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones. 5) Subjects with a history of hypersensitivity to antipsychotic agents. 6) Subjects deemed intolerant of receiving injectable treatment. 7) Subjects who have received electroconvulsive therapy within the last 7 months prior to screening. 8) Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator. 9) Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. 10) Subjects requiring hospitalization for any psychiatric reason during the 4 weeks prior to signing the ICF or during the screening period. 11) Subjects without at least 1 inpatient psychiatric hospitalization in the last 2 years (24 months) prior to screening. 12) Subjects who have met DSM-IV-TR criteria for any significant substance use disorder within 3 months prior to screening. 13) Subjects who are considered treatment-resistant to antipsychotic medication other than clozapine. 14) Treatment with long-acting injectable antipsychotics (eg, haloperidol decanoate, fluphenazine decanoate, risperidone long-acting injection [Risperdal® Consta®], paliperidone palmitate extended-release injectable suspension [Invega® Sustenna®], olanzapine for extended-release injectable suspension [Zyprexa® Relprevv®]), in which the last dose was within 7 months prior to screening. 15) Subjects who have not been treated with oral antipsychotics for 7 months prior to screening. 16) Subjects who have a significant risk of committing suicide based on history, routine psychiatric status examination, investigator’s judgment, or who have an answer of “yes” on questions 4 or 5 (current or over the last 30 days) on the baseline version of the Columbia Suicide Severity Rating Scale (C-SSRS). 17) Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the clinical judgment of the investigator. 18) Sexually active males who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 180 days following the last dose of trial medication, or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 150 days following the last dose of trial medication. Abstinence will be permitted if it is confirmed a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To further evaluate long-term safety and tolerability of aripiprazole IM depot.;Timepoint(s) of evaluation of this end point: The analysis will be performed using a McNemar test on those who have hospitalization data during months 4-6 prior to the 4-week outpatient treatment period before study entry and during months 4-6 after switch to aripiprazole IM depot. Please see protocol for more details.;Main Objective: To compare inpatient psychiatric hospitalization rates (proportion of subjects with > or = 1 inpatient psychiatric hospitalization[s]) between the retrospective period Months 4-6 (Weeks -12 to -24) while on oral standard-of-care (SOC) antipsychotic treatment(s) and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.;Primary end point(s): Efficacy: The primary endpoint of this trial is the comparison of inpatient psychiatric hospitalization rates (proportion of subjects with = 1 inpatient psychiatric hospitalization[s]) between the retrospective period Months 4-6 (Weeks -12 to -24) while on oral SOC antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after switch to aripiprazole IM depot. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The last 3 months of the retrospective and prospective (Phase B) treatment periods will be compared in the analysis of the following endpoints: - Number of inpatient psychiatric hospitalizations per subject. - Cumulative duration of inpatient psychiatric hospitalizations. - Mean duration of inpatient psychiatric hospitalizations. - Number and mean duration of all other (non-inpatient) psychiatric treatment visits including, but not limited to, partial hospitalizations, intensive outpatient programs, assertive community treatment programs, emergency room visits, hospitalizations for psychosocial reasons, etc. - Number of inpatient nonpsychiatric hospitalizations per subject. - Cumulative duration of inpatient nonpsychiatric hospitalizations. - Mean duration of inpatient nonpsychiatric hospitalizations. - Number and mean duration of all other (outpatient or non-inpatient) nonpsychiatric treatment visits including, but not limited to, emergency room visits. In addition, the following endpoints will be assessed in Phase B: - Mean change from baseline (Day 0) to Week 24 in PANSS total score. - Mean change from baseline (Day 0) to Week 24 in PANSS positive and negative subscale scores. - Mean change from baseline (Day 0) to Week 24 in CGI-S score. - Mean CGI-I score at Week 24. - Discontinuation rate due to all causes. - Time to discontinuation due to all causes. - Proportion of responders (ie, defined as > or = 30% decrease from baseline in PANSS total score or a score of 1 [very much improved] or 2 [much improved] on the CGI-I scale). - Mean change from baseline (Day 0) to Week 24 in QLS score. - Mean change from baseline (Day 0) to Week 24 in SWN-S score. - Mean change from baseline (Day 0) to Week 24 in DAI total score. - Mean change from baseline (Day 0) to Week 24 in IWQoL-Lite total score. - Mean change from baseline (Day 0) to Week 24 in IAQ total score. Safety Endpoints: Adverse events will be examined by frequency | — |
Countries
Belgium, Bulgaria, France, Germany, Italy, Poland, Spain, United Kingdom
Contacts
Public ContactClinical Trials
Centerwatch
Outcome results
None listed