| CTRI Number |
CTRI/2026/01/100088 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the benifits and side effects of long-acting olanzapine injection in patients with schizophrenia. |
|
Scientific Title of Study
|
Prospective Observational study of Effectiveness and tolerability of Olanzapine Long-Acting Injection in patients with Schizophrenia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hitarth N Patel |
| Designation |
Postgraduate Resident (MD Psychiatry) |
| Affiliation |
Dr. M.K. Shah Medical College and Research Centre and SMS Multispecialty Hospital, Ahmedabad |
| Address |
Department Of Psychiatry, Dr M.K. Shah Medical College, Near Tapovan Circle, Visat-Gandhinagar Highway, Chandkheda, Ahmedabad 382424, Gujarat, India
Ahmadabad
GUJARAT
382424
India |
| Phone |
9512403782 |
| Fax |
|
| Email |
hitarth236@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal k patel |
| Designation |
Professor and Head(MD Psychiatry) |
| Affiliation |
Dr. M.K. Shah Medical College and Research Centre and SMS Multispecialty Hospital, Ahmedabad |
| Address |
Department Of Psychiatry, Dr M.K. Shah Medical College, Near Tapovan Circle, Visat-Gandhinagar Highway, Chandkheda, Ahmedabad 382424, Gujarat, India
Ahmadabad
GUJARAT
382424
India |
| Phone |
9228249767 |
| Fax |
|
| Email |
dr.vk1987@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hitarth N Patel |
| Designation |
Postgraduate Resident (MD Psychiatry) |
| Affiliation |
Dr. M.K. Shah Medical College and Research Centre and SMS Multispecialty Hospital, Ahmedabad |
| Address |
Department Of Psychiatry, Dr M.K. Shah Medical College, Near Tapovan Circle, Visat-Gandhinagar Highway, Chandkheda, Ahmedabad 382424, Gujarat, India
Ahmadabad
GUJARAT
382424
India |
| Phone |
9512403782 |
| Fax |
|
| Email |
hitarth236@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr M.K. Shah Medical College, Near Tapovan Circle, Visat-Gandhinagar Highway, Chandkheda, Ahmedabad 382424, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Dr. M.K. Shah Medical College and Research Centre, Ahmedabad |
| Address |
Dr M.K. Shah Medical College and Research Centre,
Chandkheda Highway,
Ahmedabad – 382424,
Gujarat, India
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hitarth Patel |
SMS Multispecialty Hospital, Chandkheda, Ahmedabad |
Department of Psychiatry, SMS Multispecialty Hospital, Chandkheda, Ahmedabad
Ahmadabad
GUJARAT |
9512403782
hitarth236@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr. M.K. Shah Medical College and Research Centre,Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIl |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-60 years.
Patients with schizophrenia disorder and prescribed olanzapine long-acting injection. DSM-5TR
Patients with poor/non-compliance towards oral anti-psychotic drugs.
The patient and/or their primary caregiver is willing to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Age below 18 years and above 60 years.
Non-consent for participation in the study.
Patients who are not prescribed olanzapine LAI.
History of one or more seizures without a clear and resolved aetiology.
Significant suicidal or homicidal risk.
Pregnant or lactating women.
Acute, serious, or unstable medical conditions.
Substance (except nicotine and caffeine) dependence within the past 30 days.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impression–Severity (CGI-S) score from baseline during follow-up. For safety, Simpson-Agnus score (SAS), Barnes akathisia scale (BAS), Abnormal involuntary movement scale (AIMS), Richmond agitation sedation scale (RASS). |
At baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks and 48 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Clinical Global Impression Improvement (CGI-I) score from baseline during follow-up.
2. Occurrence & severity of extrapyramidal symptoms assessed using Simpson–Angus Scale (SAS).
3. Occurrence & severity of akathisia assessed using Barnes Akathisia Scale (BAS).
4. Occurrence & severity of abnormal involuntary movements assessed using Abnormal Involuntary Movement Scale (AIMS).
5. Level of sedation & agitation assessed using Richmond Agitation Sedation Scale (RASS).
|
At baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks,44 weeks & 48 weeks. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
19/01/2026 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a prospective observational
study, and the study aims to evaluate the safety and efficacy of olanzapine
long-acting injection in treatment nonadherent patients with schizophrenia. . The
diagnosis and the drug to be prescribed will be decided by the consultant
psychiatrist. Patients who are prescribed olanzapine long-acting injection by a
consultant psychiatrist will be included in the study. A total of 50 patients who meet the
inclusion criteria and who will provide written informed consent will be
recruited for the study. LAI of olanzapine is administered in the upper and outer
quadrant of the gluteal muscle using the Z-track technique, and after that,
patients will be kept under observation for 3 hours for post-injection delirium
and sedation syndrome. Assessment of participants will be done at every follow
up by trained resident doctor of psychiatry department during each follow-up using semi structured proforma, it includes
demographic details, positive
and negative syndrome scale
(PANSS) and Clinical global impression on severity and improvement (CGI) for
efficacy, simpson-agnus score (SAS),
Barnes akathisia scale (BAS), Abnormal
involuntary movement scale
(AIMS), Richmond agitation sedation scale (RASS) for safety. Assessment
of laboratory investigation reports will be done at screening period and then
every three months till 12 months. |