Clinical trial NCT02220712: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Aripiprazole
Deltoid
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Primary outcomes:
measure: OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections
timeFrame: 672 hours postdose of the first, second, third, fourth, and fifth IMD injections
Secondary outcomes:
Other outcomes:
Locations:
city: Chugoku Region
country: Japan
city: Hokkaido Region
country: Japan
city: Kanto Region
country: Japan
city: Kinki Region
country: Japan
city: Kyushu Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Jun-ichi Hashimoto, PhD
role: STUDY_DIRECTOR
References: