| CTRI Number |
CTRI/2025/09/095454 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
The Role of Vitamin C in Schizophrenia, Enhancing Treatment Response and Reducing brain stress. |
|
Scientific Title of Study
|
Vitamin C as an adjunct to Antipsychotics after failed trial of a single Antipsychotic in Patients with Schizophrenia and its Correlation with Malondialdehyde: 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 Subham Mondal |
| Designation |
Junior Resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Room No 74, Al Razi New PG Resident Hostel, Central Institute of Psychiatry, Kanke, Ranchi
Ranchi JHARKHAND 834006 India |
| Phone |
8159899287 |
| Fax |
|
| Email |
subham.santu.mondal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Alok Pratap |
| Designation |
Professor |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Consultant Room, K S Mani, CCN Lab, Central Institute of Psychiatry, Kanke, Ranchi
Ranchi JHARKHAND 834006 India |
| Phone |
7781803812 |
| Fax |
|
| Email |
dralokpratap@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Alok Pratap |
| Designation |
Professor |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Consultant Room, K S Mani, CCN Lab, Central Institute of Psychiatry, Kanke, Ranchi
Ranchi JHARKHAND 834006 India |
| Phone |
7781803812 |
| Fax |
|
| Email |
dralokpratap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India, 834006 |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India 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 Alok Pratap |
Central Institute of Psychiatry |
Consultant Room, K S Mani, CCN Lab, Central Institute of Psychiatry, Kanke, Ranchi Ranchi JHARKHAND |
7781803812
dralokpratap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, CIP, Ranchi |
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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Tab Vitamin C |
The interventional group would receive Tab Vitamin C 1000mg per day for 6 weeks along with antipsychotic monotherapy as usual. Serum Ascorbic Acid and Malondialdehyde levels will be estimated at baseline, 3 weeks and 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Inpatients satisfying the Clinical Description and Diagnostic Requirements CDDR 2022 for ICD 11 criteria of Schizophrenia.
2. Inadequate response i.e., less than 20 percent reduction on PANSS score from the baseline after an adequate trial i.e., at dose within the recommended therapeutic range for at least 4 to 6 weeks of one antipsychotic.
3. Current PANSS score more than 75, PANSS score 75 corresponded to moderately ill according to CGI SCH.
4. Age 18 to 60 years of both sexes.
5. Those who give informed consent for participating in the study.
|
|
| ExclusionCriteria |
| Details |
1. Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine.
2. Significant medical or neurological illness including severe cardiovascular, hepatic or renal disease, anemia, history of severe head injury or myopathy or untreated thyroid disease.
3. Any current systemic infection/inflammation.
4. Patients who received ECT in the last 6 months or currently receiving ECT or any other mode of neuromodulation.
5. Pregnancy.
6. Not willing to give written informed consent. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Antioxidant effect of Vitamin C 1000 mg per day in reducing serum levels of Malondialdehyde in patients of Schizophrenia as estimated by Immunosorbent Assay (ELISA). |
baseline, 3 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the symptoms of Schizophrenia as measured by PANSS, SAPS, SANS, MoCA scores and severity of illness measured by CGI-SCH score after receiving Tab. Vitamin C 1000 mg per day. |
Baseline, 3 weeks, 6 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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
|
Schizophrenia is a chronic, disabling psychiatric disorder affecting approximately 1 percent of the population, with high suicide risk and poor functional outcomes. It presents with positive symptoms like hallucinations and delusions, negative symptoms such as apathy and social withdrawal, and significant cognitive impairments. Despite treatment, about 40 to 50 percent of patients show inadequate response to a single antipsychotic, and around 30 percent progress to treatment resistant schizophrenia i.e., TRS, where clozapine remains the gold standard despite its serious and sometimes fatal side effects. Antipsychotics are notably ineffective in addressing negative and cognitive symptoms, highlighting the need for safer adjunctive therapies. Oxidative stress has been implicated in the pathophysiology of schizophrenia, as evidenced by elevated malondialdehyde, MDA levels and diminished antioxidants like glutathione and vitamin C, with the brain s high oxidative load making it especially vulnerable to reactive oxygen species induced neuronal damage. Vitamin C, a potent antioxidant, not only protects against oxidative stress but also supports neurotransmitter synthesis, particularly dopamine, which is central to schizophrenia s pathology. Preliminary research suggests that vitamin C supplementation may improve psychiatric symptoms and oxidative profiles in schizophrenia patients. This study proposes to evaluate the efficacy of vitamin C,1000 mg per day as an adjunctive therapy alongside antipsychotics in patients who have failed a previous antipsychotic trial. Conducted as a six week, open label, hospital based study at the Central Institute of Psychiatry, the trial will randomize 60 inpatients into two groups, with and without vitamin C. Clinical outcomes will be measured using CGI SCH, PANSS, SAPS, SANS, and MoCA at baseline, three weeks, and six weeks, while blood levels of MDA and ascorbic acid will be assessed to correlate biochemical and clinical changes. Validated clinical rating tools and ELISA based biochemical assays will be employed. If vitamin C proves effective, it could represent a low risk, accessible adjunctive option to enhance both clinical and biochemical outcomes in schizophrenia management. |