Retrospective, non-interventional, observational study to evaluate the safety and effectiveness of olanzapine long-acting injection (LAI) in the management of acutely exacerbated schizophrenia (OLIVE STUDY)

The objective of the study is to evaluate safety and effectiveness of Olanzapine LAI in patients with Schizophrenia. to achieve that we will collect data of approximately 150 patients from 4 different sited in India.

The data will be collected only if it satisfies the following inclusion and exclusion 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:

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 physician’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

The endpoints of the study are as follows:

Primary endpoint:

1. Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline, across visit 01 (4th week), visit 02 (8th week), visit 03 (12th week) in patients with Schizophrenia

Secondary endpoint:

1. Clinical Global Impression for Efficacy Index (CGI-EI) at 12th week

2. To identify patients with schizoaffective disorder if any.

3. To evaluate safety & effectiveness of OLA LAI in patients with schizoaffective disorder using PANSS & MADRS from baseline, across visit 01 (4th week), visit 02 (8th week), visit 03 (12th week)

4. Treatment Emergent Adverse Event (TEAE) assessment

The collected data will be analyzed using software like SPSS or R.