Health Condition 1: F20- Schizophrenia
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Torrent Pharmaceuticals Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients from 18 to 75 years with diagnosis of DSM-V-TR defined Schizophrenia with or without 1st episode of psychosis and/or multiple episodes of psychosis. 2. Patients diagnosed with schizophrenia and treated with OLA LAI 3. Treatment -naïve or known cases of schizophrenia who have received OAPs for 1 or 2 weeks including Oral Olanzapine (OLZ), Paliperidone (PAL), Aripiprazole (ARI), Quetiapine (QTI) & Risperidone (RIS) before initiating OLA LAI with or without PANSS and MADRS scores. 4. A Clinical Global Impressions-Improvement of Illness (CGI-EI) score less than or equal to 4. 5. Patient with PANSS score more than or equal to 75. 6. A BPRS positive symptom score more than 4 on conceptual disorganization, suspiciousness, hallucinatory behavior, and unusual thought content, grandiosity. 7. Patients should have 3 reported follow-up (between 1-12 weeks) following OLA LAI initiation (baseline visit)
Exclusion criteria
Exclusion criteria: 1. Patient aged less than 18 years and more than 75 years to be excluded 2. Patients with prominent suicidal or homicidal risk (as per physicianâ??s judgment) 3. Uncontrolled hypothyroidism 4. Pregnant or lactating women 5. Patient with PANSS score less than 75 6. Patients with other psychiatric comorbidities such as bipolar disorder (BD), major depressive disorder (MDD), post traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), and generalized anxiety disorder (GAD). 7. Patients with uncontrolled HTN, uncontrolled DM, hepatic insufficiency, and uncontrolled dyslipidemia. 8. Patients with incomplete data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Positive and Negative Syndrome Scale (PANSS) total score in patients with Schizophrenia across visitsTimepoint: baseline, visit 01 (4th week), visit 02 (8th week), visit 03 (12th week) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical Global Impression for Efficacy Index (CGI-EI)Timepoint: at 12th week;2. To identify patients with schizoaffective disorder if any.Timepoint: baseline;3. To evaluate safety & effectiveness of OLA LAI in patients with schizoaffective disorder using PANSS & MADRS across visitsTimepoint: baseline, visit 01 (4th week), visit 02 (8th week), visit 03 (12th week);4. Treatment Emergent Adverse Event (TEAE) assessmentTimepoint: visit 03 (12th week) | — |
Countries
India
Contacts
Public ContactYakshdeep Dave
Torrent Pharmaceuticals Ltd.
Outcome results
None listed