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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

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ClinicalTrials.gov Identifier: NCT02220712
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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
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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02220712


Locations
Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Jun-ichi Hashimoto, PhD Otsuka Pharmaceutical Co., Ltd.
More Information

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02220712     History of Changes
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.:
Aripiprazole
Deltoid

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs