| CTRI Number |
CTRI/2025/10/096253 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Pentoxifylline as an add-on treatment for improving memory and thinking problems (cognitive deficits) in patients with Schizophrenia, and its link to inflammation markers. |
|
Scientific Title of Study
|
Adjunctive Pentoxifylline for cognitive deficits in Schizophrenia and its inflammatory correlates: 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 |
Ishita Malik |
| Designation |
Junior Resident |
| Affiliation |
Central institute of Psychiatry |
| Address |
Room 210, Al Razi New Post Graduate Hostel, Central institute of Psychiatry Kanke, Ranchi, Jharkhand-834006
Central institute of Psychiatry
Ranchi
JHARKHAND
834006
India |
| Phone |
8800667795 |
| Fax |
|
| Email |
ishitamalik1601001117@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Paliwal |
| Designation |
Professor |
| Affiliation |
Central institute of Psychiatry |
| Address |
consultant, Central institute of Psychiatry Kanke, Ranchi, Jharkhand-834006
Ranchi
JHARKHAND
834006
India |
| Phone |
8005940887 |
| Fax |
|
| Email |
itsme.paliwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surendra Paliwal |
| Designation |
Professor |
| Affiliation |
Central institute of Psychiatry |
| Address |
consultant, Central institute of Psychiatry Kanke, Ranchi, Jharkhand-834006
Ranchi
JHARKHAND
834006
India |
| Phone |
8005940887 |
| Fax |
|
| Email |
itsme.paliwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central institute of Psychiatry,
kanke, Ranchi ,Jharkhand 834006 |
|
|
Primary Sponsor
|
| Name |
Central institute of Psychiatry |
| Address |
Central institute of Psychiatry, Kanke, Ranchi, Jharkhand-834006 |
| 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 Ishita Malik |
Central Institute of Psychiatry,Ranchi |
Central institute of Psychiatry, Kanke,Ranchi, Jharkhand 834006
Ranchi
JHARKHAND |
8800667795
ishitamalik1601001117@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, central institute of psychiatry |
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 |
drug intervention |
pentoxifylline 800mg will be given to patients of schizophrenia for 8 weeks and blood samples will be collected at baseline, 4 weeks and 8 weeks for levels of IL-6, TNF-ALPHA, BDNF, alongwith cognitive functions assessments on CANTAB, MOCA, which will be compared to patients not receiving pentoxifylline. |
| Comparator Agent |
open label study |
will be compared with patients only receiving stable dose of antipsychotics and their blood markers will be checked at baseline, 4 weeks, 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Inpatients satisfying the ICD 10- DCR (1993) criteria for Schizophrenia with duration of illness of more than 2 years
2. Age 18 to 50 years.
3. Score on MoCA less than 26.
4. CDSS score less than or equal to 6.
5. Patients who give written informed consent for participating in the study. |
|
| ExclusionCriteria |
| Details |
1. Any other major comorbid psychiatric diagnosis or significant concurrent medical illnesses.
2. Substance dependence in the last 6 months (excluding nicotine & caffeine).
3. Pregnant or lactating female patients.
4. Patients with organic brain disorder and/or mental retardation.
5. Patients on treatment with medications that can influence cognitive functioning: Anticholinergics (except trihexyphenidyl), 1st generation antipsychotics.
6. Patients on treatment with SSRI, SNRI, TCA or MAOI.
7. Patients who have received ECT in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in levels of TNF- alpha, IL-6, BDNF as marker of improvement in inflammation on Tab. Pentoxifylline 800mg/d. |
0 weeks, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in cognititve deficits measured by CANTAB, MoCA with Tab. Pentoxifylline 800mg/d. |
0 weeks, 4 weeks, 8 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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="1"
Months="6"
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
|
cognitive deficits are considered as the main core of schizophrenia, which are not caused by the side effects of antipsychotic drugs. the main affected cognitive aspects are attention, memory, reasoning, processing speed, and executive functions. studies show that biological events during the neurodevelopmental phase in adolescents leads to abnormal synaptic plasticity resulting in cognitive deficits. the key roles of TNF-Alpha, and IL-6 in regulating the excitability transmission of neuron cell and neurotransmitter metabolisms make them primary candidates for schizophrenia pathogenesis. patients with chronic schizophrenia exhibited elevated serum IL-6, TNF- Alpha, sIL-2R, IL-1beta and IL-18. Pentoxifylline is a methylxanthine derivative with anti-inflammatory and immune modulation effects; it increases the red blood cells membrane elasticity and decreases the blood viscosity and platelet aggregation so that it increases the blood flow. therefore pentoxifylline 800mg BD will be given to patients for 8 weeks and blood markers will be checked at baseline. 4 weeks and 8 weeks alongwith scales for cognition. |