A Multicenter, Prospective, Post Marketing Surveillance study ofAripiprazole tablet in Adolescent patients with Schizophrenia
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- Safety endpoints:
研究概览
简要总结
Aripiprazole Tablets (2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg) are
approved and available in Indian market for the treatment of
schizophrenia in adolescents. Safety and tolerability of aripiprazole are
well established in various clinical trials. The current study has been
planned to collect safety and tolerability data of aripiprazole tablet in the
adolescents population in India.This study will be an open label, multi-centric, prospective, single arm
study. The study includes enrolment visit (Day 1), followed by telephonic safety
assessment (week 1, 2, 3, 4), and end of study visit (week 6).
Patients will be screened for the eligibility. The screening procedure will
be conducted after obtaining Assent from patients and Informed consent
form from parents respectively.
Adolescent patients with schizophrenia who fulfill the eligibility criteria
will be enrolled in the study as per the investigator’s discretion. Patients
shall receive designated daily dose of Aripiprazole tablet (2 mg to 30 mg)
once in a day throughout the study i.e. 6 weeks. The dose and time of
administration of aripiprazole will be based on investigator’s discretion.
As per the prescribing information, the initial dose of tablet will be 2 mg,
which will be titrated to 5 mg after 2 days and 10 mg after 2 additional
days. When appropriate, subsequent dose will be increased in 5 mg
increments without exceeding the maximum daily dose of 30 mg.
Aripiprazole is effective in a dose range of 10 to 30 mg/day. After up
titrating the dose, if a patient is not able to tolerate the given study
medication dose, will be down titrated as per the investigator’s
discretion. Safety evaluation will be performed every week
telephonically for the first 4 weeks and at the end of the study.
Each participant shall be required to visit the study sites for:
• Visit 1: Enrolment visit (Day 1)
• Telephonic safety assessment : (Week 1 ± 3days)
• Telephonic safety assessment : (Week 2 ± 3days)
• Telephonic safety assessment : (Week 3 ± 3days)
• Telephonic safety assessment : (Week 4 ± 3days)
• Visit 2 : End of study visit (Week 6 ± 4 days)
The study will be carried out according to the protocol approved by the
institutional ethical committee (IEC) of the participating site/institution.
The study will be conducted in accordance with the “Declaration of
Helsinki†and “ICH-Good clinical practice†guidelines and pertinent
regulatory requirements
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 13.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female adolescent patients aged 13 to 17 years (both inclusive)
- •Patients diagnosed with schizophrenia according to the International Classification of Diseases (ICD) and who as per investigator discretion need aripiprazole therapy.
排除标准
- •Patients with known hypersensitivity to aripiprazole.
- •Patients with concurrent psychiatric comorbidity requiring pharmacotherapy and/or medications.
- •Any evidence of suicide risk; or a history or current diagnosis of schizoaffective disorder, mental retardation, major depressive episodes, neuroleptic malignant syndrome, any neurologic disorder other than Tourettes syndrome, severe head trauma, or any unstable medical condition
- •Pregnant or lactating and sexually active adolescent boys or adolescent girls who do not agree to abstinence or birth control
- •In the opinion of the investigator patient is either unable to cooperate or unlikely to adhere with any study procedures.
结局指标
主要结局
Safety endpoints:
时间窗: Visit 1, Day 1 | Visit 2, Week 6 ± 4 days
1. Frequency and severity of adverse events.
时间窗: Visit 1, Day 1 | Visit 2, Week 6 ± 4 days
2. Clinical laboratory assessments (haematology and biochemistry)
时间窗: Visit 1, Day 1 | Visit 2, Week 6 ± 4 days
3. Vital signs and Physical Examination
时间窗: Visit 1, Day 1 | Visit 2, Week 6 ± 4 days
次要结局
未报告次要终点