Clinical trial NCT03287505: Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Official title: Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
First posted: 2017-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24 patients with oral tolerance of this drug.

In this study, the washout period before administration is designed as a 35-day duration before administration of the investigational drug (aripiprazoleIM Depot), screening period a 4-week duration (28 days) before administration of the investigational drug, observation period after administration a 20-week duration after administration of the investigational drug and hospital stay a minimum 35-day duration after administration of the investigational drug.

Eligibility criteria: Inclusion Criteria:

1. Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
3. 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 Criteria:

1. Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR;
2. Score of Positive and Negative Syndrome Scale (PANSS): ≥120;
3. Patients with a complication or a history of diabetic mellitus;
4. Subjects who are alcoholemia overdependent of drug, or have drug abuse history;

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Maximum Plasma Concentration
timeFrame: up to 20 weeks
measure: Time of Maximum Concentration
timeFrame: up to 20 weeks
measure: AUC0-∞
timeFrame: up to 20 weeks
measure: Apparent clearance after extravascular administration
timeFrame: up to 20 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: up to 20 weeks
measure: Vital Signs
timeFrame: up to 20 weeks
measure: Laboratory Examination
timeFrame: up to 20 weeks
Other outcomes:
measure: Positive and Negative Symptoms Scale (PANSS)
timeFrame: up to 20 weeks
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital of Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Anding Hospital of Capital Medical University
name: Tao Jiang, Master
role: PRINCIPAL_INVESTIGATOR
References: