| CTRI Number |
CTRI/2026/03/107153 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study to see the outcome of adding Lumateperone if it helps win improving interaction and thinking skills in people with Schizophrenia. |
|
Scientific Title of Study
|
Lumateperone as an adjunctive therapy in negative and cognitive symptoms of Schizophrenia: An open label study |
| 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 Rishabh Nagar |
| Designation |
Junior Resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
room 46, Department Of Psychiatry, CENTRAL INSTITUTE OF PSYCHIATRY
CENTRAL INSTITUTE OF PSYCHIATRY,RANCHI,jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
8602075117 |
| Fax |
|
| Email |
drrishabhn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Pratap |
| Designation |
Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of Psychiatry CENTRAL INSTITUTE OF PSYCHIATRY
CENTRAL INSTITUTE OF PSYCHIATRY,RANCHI,jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
7781803812 |
| Fax |
|
| Email |
dralokpratap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjanik K Rajan |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
central Institute of Psychiatry |
| Address |
Department of Psychiatry, CENTRAL INSTITUTE OF PSYCHIATRY
CENTRAL INSTITUTE OF PSYCHIATRY, KANKE, RANCHI, JHARKHAND
Ranchi
JHARKHAND
834006
India |
| Phone |
7766817961 |
| Fax |
|
| Email |
dranjanikkumarcip@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand-834006 |
|
|
Primary Sponsor
|
| Name |
Central Institute Of Psychiatry, Ranchi |
| Address |
Central Institute Of Psychiatry, kanke Ranchi 834006,Jharkhand |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rishabh Nagar |
Central institute of Psychiatry |
Research lab, Central Institute of Psychiatry Kanke Ranchi Jharkhand 834006
Ranchi
JHARKHAND |
8602075117
drrishabhn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe, CIP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To assess the effect of Lumateperone as an adjunctive treatment for 6 weeks for negative symptoms and
cognitive deficit in schizophrenia. |
30 patients receiving Cap. Lumateperone (42mg/day) + treatment as usual for 6 weeks |
| Comparator Agent |
treatment for negative symptoms and
cognitive deficit in schizophrenia for 6 weeks |
30 patients receiving treatment as usual for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. participants satisfying the ICD-11 criteria for schizophrenia
2.illness duration of equal to or more than 2 years
3. patient giving written informed consent
4. score less than or equal to 25 in Hindi Montreal cognitive assessment test
5. PANSS negative symptoms score of equal to or more than 4 or more than 15 combined.
6. SANS score more than 20 |
|
| ExclusionCriteria |
| Details |
1. Any other major comorbid psychiatric diagnosis or significant concurrent medical illness.
2. Patients with organic brain disorder and/or mental retardation.
3. Patients on treatment with medications that can influence cognitive functioning:
Anticholinergics (except trihexyphenidyl).
4. Patients who have received ECT in the past 6 months.
5. Contraindications to use of Lumateperone. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the severity of negative symptoms from baseline to 4 week
SANS (Scale for Assessment of Negative Symptoms) total score and PANSS (Positive and Negative Syndrome Scale) negative subscale score.
|
Baseline and 4 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in cognitive performance scores from baseline to 4 weeks.
BACS (Brief Assessment of Cognition in Schizophrenia) composite score and MoCA (Montreal Cognitive Assessment) total score.
|
Baseline and 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/04/2026 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Schizophrenia patients with negative and cognitive symptoms will be recruited and divided into 2 groups. one group will receive Tab Lumateperone 42mg OD for 4 weeks and will be clinically assessed using scales like BACS, and compared with baseline. Another group will receive usual treatment and compared with the other group. |