None listed
Conditions
Interventions
Group 1 Type of group
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Group name:Group 2 Type of group
Patients received placebo intramuscularly every 28 days for 52 weeks.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC),
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: • Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by the Institutional Review Board/Institutional Ethics Committee [IRB/IEC]), prior to the initiation of any protocol-required procedures. • Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent. • Subjects with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition text revision (DSM-IV-TR) criteria and a history of the illness for at least 3 years prior to screening. • Subjects who, in the investigator´s judgment, require chronic treatment with an antipsychotic medication. • Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications; who can read and understand the written word in order to complete patient-reported outcomes measures; and who can be reliably rated on assessment scales.
Exclusion criteria
Exclusion criteria: • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, or amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. • Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine. • Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator´s judgment. • Subjects who currently meet DSM-IV-TR criteria for substance dependence, including alcohol and benzodiazepines, but excluding caffeine and nicotine; or 2 positive drug screens for cocaine. • Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones; or hypersensitivity to antipsychotic agents. • Subjects with uncontrolled thyroid function abnormalities. • Subjects with a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose them to undue risk or interfere with study assessments. • Subjects who are involuntary incarcerated. • Subjects who have used an investigational agent within 30 days of screening or prior participation in a clinical study with aripiprazole IM depot. • Subjects with clinically significant abnormalities in laboratory test results, vital signs, or ECG results; and subjects hospitalized for more than 30 days in the 90 days prior to Phase 1. • Subjects who fail to wash-out from prohibited concomitant medications, including the use of CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers, antipsychotics, antidepressants (including monoamine oxidase inhibitors [MAOI}), and mood stabilizers during screening and/or Phase 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A patient experienced an exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. Measure:Time to Exacerbation of Psychotic Symptoms/Impending Relapse Timepoints:Baseline of the depot maintenance phase to the end of the study (Week 52) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria Measure:Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria Timepoints:Baseline of the depot maintenance phase to the end of the study (Week 52) ; Outcome name:A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. Measure:Percentage of Responders Timepoints:Baseline of the depot maintenance phase to the end of the study (Week 52) ; Outcome name:A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6). Measure:Percentage of Patients Achieving Remission Timepoints:Baseline of the depot maintenance phase to the end of the study (Week 52) ; Outcome name:The PANSS consists of 3 subscales (Positive Subscale, 7 constructs, scores ranged from 7-49, Negative Subscale, 7 constructs, scores ranged from 7-49, General Psychopathology Subscale, 16 constructs, scores ranged from 16-112) containing a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of | — |
Countries
Argentina, Bulgaria, India, Lithuania, Malasya, Mexico, Peru, Philippines, Romania, Russian Federation, Serbia, Slovakia, Taiwan, Ukraine, United States
Contacts
Public ContactFRANCISCO NICOLAS LAVADO
COVANCE PERU SERVICES S.A.
Outcome results
None listed