Status:
COMPLETED
Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Lead Sponsor:
Otsuka Beijing Research Institute
Conditions:
Schizophrenia
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.
Detailed Description
In this study, a single-center, single-dose, single-administration trial will be carried out in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of Mental Disord...
Eligibility Criteria
Inclusion
- Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
- Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
- subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.
Exclusion
- Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR;
- Score of Positive and Negative Syndrome Scale (PANSS): ≥120;
- Patients with a complication or a history of diabetic mellitus;
- Subjects who are alcoholemia overdependent of drug, or have drug abuse history;
- Other protocol-defined inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
June 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03287505
Start Date
June 23 2017
End Date
November 8 2019
Last Update
December 29 2020
Active Locations (1)
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1
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, China, 100088