Aripiprazole, Abilify Maintena Collaborative Clinical Protocol

This is an interventional treatment trial for Schizophrenia Read More

Inclusion Criteria:

• Are able to provide written informed consent.
• Are male and female subjects 18 to 65 years of age, inclusive, at time of informed consent
• Have a current diagnosis of schizophrenia as defined by DSM-5 criteria and a history of the illness for at least 6 months prior to screening from a reliable source (e.g., subject, family member, friend, caregiver, healthcare provider, or medical records)
• Present at one of the selected inpatient units with acute psychotic symptoms for hospitalization at study entry
• Have a clinically indicated need for a change in current antipsychotic therapy
• Are on Medicaid with searchable claims data
• Have at least one inpatient psychiatric hospitalization or psychiatric ED visit within the 6 months prior to screening
• Have been previously prescribed oral antipsychotic treatment for the 6 consecutive months prior to screening
• Have a history of response to antipsychotic treatment, with no history of clozapine treatment
• Are able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, aripiprazole once monthly injection, and discontinuation of prohibited concomitant medications
• Are able to read and understand the written word in order to complete subject-reported outcomes measures
• Are willing to accept a monthly injection
• Are male and female subjects who are surgically sterile (i.e., have undergone orchiectomy or hysterectomy, respectively); female subjects who have been postmenopausal for at least 12 consecutive months; or male and female subjects who agree to use an approved form of birth control during study participation

Exclusion Criteria:

• Has a current DSM-5 diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also excluded are subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
• Prisoners or subjects who are involuntarily incarcerated, or have been incarcerated in the past 7 months for any reason
• Require potent cytochrome P450 (CYP)2D or CYP3A4 inhibitors or CYP3A4 inducers
• Are allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones or has a history of hypersensitivity to antipsychotic agents
• Have received electroconvulsive therapy within the 6 months prior to screening
• Have a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator
• Have current diagnosis of diabetes or known fasting triglyceride levels consistent with risk for pancreatitis
• Meets DSM-5 criteria for current substance use disorder within 3 months prior to screening
• Received treatment with long-acting injectable antipsychotics (e.g., 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
• 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 Question 4 or Question 5 within the last 30 days on the baseline version of the C-SSRS
• Have a history or evidence of a medical condition that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the study, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the clinical judgment of the investigator
• Have results from one or more of the following laboratory test, vital sign, and ECG tests at screening that are exclusionary (laboratory testing and ECGs will be performed locally): Platelets ≤ 75,000/mm3; Hemoglobin ≤ 9 g/dL; Fasting blood glucose > 126 mg/dL or HbA1c > 7.0%; Fasting triglyceride > 500 mg/dL; Neutrophils, absolute ≤ 1000/mm3; Aspartate transaminase (AST) > 3x ULN; Alanine transaminase (ALT) > 3x ULN; Creatinine ≥ 2 mg/dL; Diastolic blood pressure > 105 mmHg; QTc > 475 msec on either the QTcB (Bazett) or QTcF (Fridericia) corrections on ECG, confirmed by a second tracing; Any other abnormal laboratory tests, vital sign results, or ECG findings that, in the judgment of the investigator, are medically significant and would affect the safety of the subject or the interpretation of the study results. Abnormal results for laboratory parameters or vital signs should be repeated to ensure reproducibility of the abnormality before excluding a subject based on the criteria noted above.
• Have been previously enrolled in an aripiprazole once monthly clinical study
• Have participated in any clinical study with an investigational agent within the past 30 days
• Are pregnant or lactating