| CTRI Number |
CTRI/2025/05/087528 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Cognitive Remediation and Transcranial Random Noise Stimulation in Schizophrenia |
|
Scientific Title of Study
|
Cognitive Remediation and Transcranial Random Noise Stimulation in Stable patients of Schizophrenia: A Randomized Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Huma Fatima |
| Designation |
PhD Scholar |
| Affiliation |
King George Medical University |
| Address |
Research room department of psychiatry
Shamina Road Chowk Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9810675536 |
| Fax |
|
| Email |
fatimahuma786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Singh |
| Designation |
Professor |
| Affiliation |
King George Medical University |
| Address |
Department of Psychiatry KGMU
Shamina Road Chowk Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9557565222 |
| Fax |
|
| Email |
shwetabhanu3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Huma Fatima |
| Designation |
PhD Scholar |
| Affiliation |
King George Medical University |
| Address |
Research Room Department of Psychiatry KGMU
Shamina Road Chowk Lucknow
Lucknow
UTTAR PRADESH
226001
India |
| Phone |
9810675536 |
| Fax |
|
| Email |
fatimahuma786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry KGMU Lucknow India Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [PI] |
|
|
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 Shweta Singh |
Research Room Department of Psychiatry KGMU |
Shahmina Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH |
09557565222
fatimahuma786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee King Geoges Medical University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F202||Catatonic schizophrenia, (2) ICD-10 Condition: F201||Disorganized schizophrenia, (3) ICD-10 Condition: F208||Other schizophrenia, (4) ICD-10 Condition: F200||Paranoid schizophrenia, (5) ICD-10 Condition: F205||Residual schizophrenia, (6) ICD-10 Condition: F209||Schizophrenia, unspecified, (7) ICD-10 Condition: F203||Undifferentiated schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Remediation |
Cognitive Remediation program for 2 month with 6 months of follow-up |
| Comparator Agent |
tRNS |
10 sessions of tRNS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Schizophrenia patients |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
cognition
psychopathology
|
Baseline, 16 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
05/06/2025 |
| 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 Yet Recruiting |
| 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
|
This is my PhD work/thesis. I am doing my PhD at KGMU, Lucknow, India. It is a Randomized Controlled Study. Random allocation will be done by sealed envelope by computer generated random numbers. |