Health Condition 1: F209- Schizophrenia, unspecified
Conditions
Interventions
Intervention1: 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: Aripiprazole tablet As per the prescribing informati
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female adolescent patients aged 13 to 17 years (both inclusive) 2. Patients diagnosed with schizophrenia according to the International Classification of Diseases (ICD) and who as per investigator discretion need aripiprazole therapy
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to aripiprazole. 2. Patients with concurrent psychiatric comorbidity requiring pharmacotherapy and/or medications. 3. 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 4. Pregnant or lactating and sexually active adolescent boys or adolescent girls who do not agree to abstinence or birth control 5. In the opinion of the investigator patient is either unable to cooperate or unlikely to adhere with any study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints: 1. Frequency and severity of adverse events. 2. Clinical laboratory assessments (haematology and biochemistry) 3. Vital signs and Physical ExaminationTimepoint: Visit 1, Day 1 Visit 2, Week 6 Ã?± 4 days | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDrRam Gupta
Torrent Research Centre
Outcome results
None listed