CTRI

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CTRI Number

CTRI/2025/10/095748 [Registered on: 08/10/2025] Trial Registered Prospectively

Last Modified On:

20/05/2026

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Single Arm Study

Public Title of Study

Observational study to check safety and benefits of olanzapine injection for people with schizophrenia.

Scientific Title of Study

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)

Trial Acronym

OLIVE

Secondary IDs if Any

Secondary ID	Identifier
TPL2508024, Version: 01, Dated: 11/09/2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Vishal Patel
Designation	Psychiatrist
Affiliation	Brain & Behaviour Mental Health Clinic
Address	501/A, Shlok Infinity, Opp Vishwakarma Temple, Gota-Chandlodia Road, Chandlodia, Ahmedabad Ahmadabad GUJARAT 382481 India
Phone	9228249767
Fax
Email	dr.vk1987@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Zahraan Qureshi
Designation	Assistant General Manager
Affiliation	Torrent Pharmaceuticals Ltd.
Address	Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India Ahmadabad GUJARAT 380009 India
Phone	7069000629
Fax
Email	zahraanqureshi@torrentpharma.com

Details of Contact Person
Public Query

Name	Yakshdeep Dave
Designation	Manager
Affiliation	Torrent Pharmaceuticals Ltd.
Address	Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India Ahmadabad GUJARAT 380009 India
Phone	7069000425
Fax
Email	yakshdeepdave@torrentpharma.com

Source of Monetary or Material Support

Torrent Pharmaceuticals Ltd. Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India

Primary Sponsor

Name	Torrent Pharmaceuticals Ltd.
Address	Torrent House, Off. Ashram Road, Ahmedabad - 380009, Gujarat, India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	N/A

Countries of Recruitment

India

Sites of Study

No of Sites = 4
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vishal Patel	Brain & Behaviour Mental Health Clinic	501/A, Shlok Infinity, Opp Vishwakarma Temple, Gota-Chandlodia Road, Chandlodia, Ahmedabad Ahmadabad GUJARAT	9228249767 dr.vk1987@gmail.com
Dr Shashi Bhushan Kumar Gupta	Health Mind Clinic	Basement, Ashtavakra Institute of Rehabilitation Sciences & Research 5 PSP Institutional Area, Madhuban Chowk, Rohini, Delhi-110085 North West DELHI	7048979076 SHASHI2007PMCH@GMAIL.COM
Dr Subrata Naskar	Snayubikshan	139, Santoshpur Avenue, Kolkata-700075 Kolkata WEST BENGAL	7980832456 nsubrata.edu@gmail.com
Dr C Panneer Selvan	Sneka Mindcare Hospital	12, Near Railway Bridge, South Byepass Road, Tirunelveli Tirunelveli TAMIL NADU	9842131550 panneerpsychiatrist@gmail.com

Details of Ethics Committee

No of Ethics Committees= 4
Name of Committee	Approval Status
Sangini Ethics Committee	Approved
Sangini Ethics Committee	Approved
Sangini Ethics Committee	Approved
Sangini Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: F20\|\|Schizophrenia,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	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)

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

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

Secondary Outcome

Outcome	TimePoints
1. Clinical Global Impression for Efficacy Index (CGI-EI)	at 12th week
2. To identify patients with schizoaffective disorder if any.	baseline
3. To evaluate safety & effectiveness of OLA LAI in patients with schizoaffective disorder using PANSS & MADRS across visits	baseline, visit 01 (4th week), visit 02 (8th week), visit 03 (12th week)
4. Treatment Emergent Adverse Event (TEAE) assessment	visit 03 (12th week)

Target Sample Size

Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

19/10/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

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.