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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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