| CTRI Number |
CTRI/2025/09/095310 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
High-Dose Betahistine and Its Impact on Cognition and Metabolism in Schizophrenia patients |
|
Scientific Title of Study
|
High Dose Betahistine In Schizophrenia Metabolic Effects And Cognitive Function |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yash Modi |
| Designation |
Junior Resident |
| Affiliation |
Central Institute Of Psychiatry |
| Address |
Department of Psychiatry Room no 12 Al Razi Hostel Central Institute of Psychiatry, Ranchi Jharkhand India 834006
Ranchi
JHARKHAND
834006
India |
| Phone |
9537285566 |
| Fax |
|
| Email |
dryashmodipsy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Paliwal |
| Designation |
Professor of Psychiatry |
| Affiliation |
Central Institute Of Psychiatry |
| Address |
Department of Psychiatry, Central Institute of Psychiatry, Ranchi Jharkhand India 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 of Psychiatry |
| Affiliation |
Central Institute Of Psychiatry |
| Address |
Department of Psychiatry, Central Institute of Psychiatry, Ranchi Jharkhand India 834006
JHARKHAND
834006
India |
| Phone |
8005940887 |
| Fax |
|
| Email |
itsme.paliwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute Of Psychiatry, Kanke, Ranchi, India Pin Code 834006 |
|
|
Primary Sponsor
|
| Name |
Central Institute Of Psychiatry |
| Address |
Central Institute of Psychiatry, Ranchi Jharkhand India 834006 |
| 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 Yash Modi |
Central Institute Of Psychiatry |
Central Institute Of Psychiatry Kanke, Kanke Road, Patratoli Ranchi 834006
Ranchi
JHARKHAND |
9537285566
yashmodi6636@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
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 |
Betahistine drug |
Group 1 will consist of 20 patients who will receive high-dose Betahistine at a total daily dose of 72 mg, divided into three doses for 8 weeks, in combination with the antipsychotic medication Olanzapine. |
| Comparator Agent |
No drug |
Group 2 will consist of 20 patients who will receive only the antipsychotic medication Olanzapine for 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
2 First episode schizophrenia (Duration less than or equal to 2 Years)
3 Age 18 to 50 years of either gender
4 Patients with Healthy BMI (18.5 to 24.9) and not fulfilling the criteria for Metabolic Syndrome
5 Patient currently on Tab. Olanzapine as Second Generation Antipsychotics
6 Score on MoCA less than 26
7 Moderately severe or less ( Less than or equal to 5) severity rating on PANSS items
8 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 Pregnant or lactating female patients
3 Patients with organic brain disorder and or mental retardation
4 Patients on treatment with medications that can influence cognitive functioning like Anticholinergics (except trihexyphenidyl) 1st generation antipsychotics
5 Patients on treatment with medications that can influence metabolic profile
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
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tab. Betahistine (72mg per day in 3 divided doses) will help in improving the metabolic and cognitive effects in the patient of schizophrenia with Olanzapine |
Tab. Betahistine (72mg per day in 3 divided doses) will help in improving the metabolic and cognitive effects in the patient of schizophrenia with Olanzapine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/10/2025 |
| 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="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 severe psychiatric disorder marked by positive, negative, and cognitive symptoms that significantly impair functioning. Second-generation antipsychotics (SGAs), particularly Olanzapine, are widely used for treatment but are associated with adverse metabolic effects such as weight gain, dyslipidemia, and increased risk of metabolic syndrome. These metabolic disturbances may further contribute to cognitive decline in patients with schizophrenia.
Betahistine, a histamine H1 receptor agonist and H3 receptor antagonist, has shown promise in mitigating SGA-induced metabolic side effects and improving cognitive functions. This open-label clinical trial, conducted at the Central Institute of Psychiatry, Ranchi, aims to evaluate the metabolic and cognitive effects of high-dose Betahistine (72 mg/day) when used as an adjunct to Olanzapine in patients with schizophrenia.
A total of 40 drug-naïve patients, aged 18–50 years and diagnosed with first-episode schizophrenia, will be randomly allocated into two groups. Group 1 will receive Betahistine plus Olanzapine, and Group 2 will receive Olanzapine alone. Assessments will be carried out at baseline, 4 weeks, and 8 weeks, including metabolic profile, cognitive tests (MoCA, CANTAB), serum Neuropeptide Y levels, and symptom severity (PANSS, CGI).
The study aims to explore whether Betahistine can reduce Olanzapine-induced metabolic side effects and enhance cognitive performance in schizophrenia patients. |