Post marketing surveillance of Aripiprazole tablet
- Conditions
- Health Condition 1: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2022/01/039860
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method