Comparison of Cariprazine and Risperidone in treatment of Schizophrenia.
- Conditions
- Health Condition 1: F20- Schizophrenia
- Registration Number
- CTRI/2023/09/057293
- Lead Sponsor
- Government Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Persons diagnosed with Schizophrenia as per ICD-11.
2. Persons of all genders, aged between 18-65 years.
3. Drug naïve patients only.
4. Duration of illness not more than 2 years.
5. Patients or Nominated representatives (in case of patients who lack capacity for making decisions for treatment as per Mental Healthcare Act-2017) willing to give consent for the study.
6. Patients being accompanied by reliable informants.
1. Patients with neurological disorders - head injury, tumours, dementia, organic brain syndromes (e.g. delirium, amnesia), epilepsy.
2. Patients with co-morbid substance dependence (except Nicotine and Caffeine).
3. Patients who are lactating or pregnant.
4. Patients with Intellectual disability.
5. Actively suicidal patients.
6. Patients with any acute, unstable medical/surgical illnesses.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the severity of psychiatric symptomatology as measured by PANSS, BPRS.Timepoint: 0, 2, 4, 7, 10 weeks
- Secondary Outcome Measures
Name Time Method Effect of treatment on quality of life, current functioning & neuropsychological assessments as measured on CDSS, WHOQOL BREF, GASS, SOFS, CGI, ASEX, MOCA, blood & other related investigations.Timepoint: 0, 2, 4, 7, 10 weeks
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