A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• Patients with a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM)-IV-Text Revision (TR) (295.30, 295.10, 295.20, 295.90, 295.60)

• Patients who have provided written informed consent by themselves (If the patient is a minor, written consent from a legal representative must be obtained in addition to the patient's own written informed consent.)

• Patients, both male and female, aged 18 years or older, but younger than 65 years, at the time of obtaining informed consent

• Patients with a body mass index of 18.5 or higher and lower than 35.0

• Patients whose mental condition is stable or well maintained for 2 weeks or more without any change to dosage regimen for their non-aripiprazole oral atypical antipsychotic monotherapy prior to obtaining informed consent

• Patients who have received aripiprazole in the past

Exclusion Criteria:

• Patients diagnosed as having a mental disorder other than schizophrenia, as defined by DSM-IV-TR criteria.

• Patients with a history or complication of diabetes.

• Patients with hepatic, renal, cardiac, or hematopoietic disorders.

• Female patients who are pregnant or lactating, who may possibly be pregnant, who wish to become pregnant, or male patients whose partner wishes to become pregnant.

• Patients who have a drug allergy or drug hypersensitivity

• Patients for whom clozapine has been ineffective, patients who have responded only to clozapine, or patients who are currently being treated with clozapine.

• Patients with a complication of Parkinson's Disease (excluding drug-induced Parkinsonism).

• Patients with a history or a complication of neuroleptic malignant syndrome, rhabdomyolysis, tardive dyskinesia, paralytic ileus or water intoxication.

• Patients with a history or a complication of psychological or behavioral abnormalities associated with use of psychoactive substances (abuse of alcohol, narcotics, or organic solvent, etc).

• Patients with a history or a complication of suicide attempt or self-injury within 52 weeks prior to obtaining informed consent.

• Patients with a history of or a complication of convulsive disorder such as epilepsy.

• Patients with a history of or a complication of organic brain disorder including cerebrovascular disease.

• Patients with a history or a complication of granulocytopenia or agranulocytosis.

• Patients who have received electro-convulsive therapy (ECT) within 12 weeks prior to obtaining informed consent.