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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 November 2015 |
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Main ID: |
NCT02220712 |
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Date of registration:
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18/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Date of first enrolment:
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July 2014 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02220712 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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Phase 1
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Countries of recruitment
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Japan
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Contacts
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Name:
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Jun-ichi Hashimoto, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Otsuka Pharmaceutical Co., Ltd. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: OPC-14597 IMD
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Primary Outcome(s)
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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]
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Secondary ID(s)
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031-13-005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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