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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: OPC-14597 IMD

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chugoku Region, Japan
  • Hokkaido Region, Japan
  • Kanto Region, Japan
  • Kinki Region, Japan
  • Kyushu Region, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug: OPC-14597 IMD	Drug: OPC-14597 IMD; Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: August 18, 2014
• First Submitted That Met QC Criteria: August 18, 2014
• First Posted (Estimate): August 20, 2014

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Aripiprazole; Deltoid
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: 031-13-005; JapicCTI-142635 (Other Identifier: Japic)