| CTRI Number |
CTRI/2025/07/091291 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the efficacy and safety of Olanzapine and Cariprazine in the treatment of acute psychosis. |
|
Scientific Title of Study
|
Comparative Efficacy and Safety of Olanzapine and Cariprazine in Patients of Acute Psychosis in a Tertiary Care Hospital Of Western Uttar Pradesh. |
| 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 Ekta Arora |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pharmacology
Kasna
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
07678684969 |
| Fax |
|
| Email |
ektaarora@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Fahad Saifi |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pharmacology
Kasna
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8802872904 |
| Fax |
|
| Email |
fahadsaifi97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fahad Saifi |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department of Pharmacology
Kasna
Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
8802872904 |
| Fax |
|
| Email |
fahadsaifi97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences (GIMS) Greater Noida |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences (GIMS) Greater Noida |
| Address |
Kasna Greater Noida Uttar Pradesh India pin-201310 |
| Type of Sponsor |
Government 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 |
| Dr Ekta Arora |
Government Institute of Medical Sciences (GIMS) |
Department of Pharmacology GIMS Academic Block
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
7678684969
ektaarora@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F28||Other psychotic disorder not due to a substance or known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Olanzapine |
5mg per day subsequent increase dose up to 20 mg per day |
| Comparator Agent |
Cariprazine |
1.5 mg per day subsequent increase dose up to 6 mg per day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with acute psychosis.
2.Willingness to participate and provide informed consent
3.Treatment naive patient or patients not taking any antipsychotic medication for last
one month. |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.;
2.Severe Medical Illnesses and co morbid conditions
3.Any known Contra-indications to the use of Olanzapine and Cariprazine example
known allergy or hypersensitivity
4.Treatment-resistant psychosis.
5.History of substance abuse or dependence. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy and safety of Olanzapine and Cariprazine in the treatment of acute psychosis. |
From baseline to End of Treatment at 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the quality of life using Quality Adjusted Life Years Questionnaire
in patients of acute psychosis |
From baseline to End of Treatment at 90 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Inclusion of Eligible Patients: Patients fulfilling the inclusion/exclusion criteria will
be enrolled after obtaining written informed consent using the Institutional Ethics
Committee–approved Informed Consent Form (ICF). Demographic details such as age,
gender, education, contact number, and address will be recorded.
c) Group Allocation:
Patients will be randomized via computer-generated codes into:
Group 1: Olanzapine (5–20 mg/day)
Group 2: Cariprazine (1.5–6 mg/day)
d) Baseline Assessments:
Prior to treatment initiation, the following scales and measurements will be recorded:
Brief Psychiatric Rating Scale (BPRS), Simpson Angus Scale (SAS), Barnes Akathisia
Scale, AIMS (Abnormal Involuntary Movement Scale) and Weight, Blood Pressure, Blood
Glucose, Lipid Profile |