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
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: OPC-14597 IMD
Intervention description: Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
Intervention MeSH terms: Aripiprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Aripiprazole; Deltoid

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
    

Eligibility 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.