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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02220712
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : October 22, 2015
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: OPC-14597 IMD Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : July 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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

Primary Outcome Measures :
  1. Plasma concentration-time profiles (including C28d of plasma aripiprazole and its main metabolite OPC-14857) [ Time Frame: Day1, 2, 3, 4, 5,6, 8, 12, 15, 20, 22, 29, 57,85, 113, 114, 115, 116, 117, 118, 120, 124, 127, 134, 141, 155, 169 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02220712

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Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
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Study Director: Jun-ichi Hashimoto, PhD Otsuka Pharmaceutical Co., Ltd.
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Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT02220712    
Other Study ID Numbers: 031-13-005
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015
Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists