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

NCT ID: NCT02220712

Last Updated: 2021-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-04-30

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

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Drug: OPC-14597 IMD

Group Type: EXPERIMENTAL

OPC-14597 IMD

Intervention Type: DRUG

Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Interventions

OPC-14597 IMD

Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun-ichi Hashimoto, PhD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Chugoku Region, , Japan

Hokkaido Region, , Japan

Kanto Region, , Japan

Kinki Region, , Japan

Kyushu Region, , Japan

Countries

Japan

Other Identifiers

JapicCTI-142635

Identifier Type: OTHER

Identifier Source: secondary_id

031-13-005

Identifier Type: -

Identifier Source: org_study_id