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

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220712
• Other study ID #: 031-13-005
• Secondary ID: JapicCTI-142635
• Status: Completed
• Phase: Phase 1
• Start date: July 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• OPC-14597 IMD
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections		672 hours postdose of the first, second, third, fourth, and fifth IMD injections