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CTRI Number  CTRI/2024/05/067542 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 10/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To assess the effectiveness and safety of adding L-methyltetrahydrofolate in addition to fluvoxamine in patients with Obsessive compulsive Disorder 
Scientific Title of Study   Efficacy and Safety of Fluvoxamine alone and in combination with L-Methyltetrafolate in patients with Obsessive Compulsive Disorder 
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 Rakesh Mittal 
Designation  Professor 
Affiliation  PT B.D. Sharma PGIMS Rohtak 
Address  3rd floor,Department of Pharmacology,PGIMS ,Rohtak

Rohtak
HARYANA
124001
India 
Phone  9034040290  
Fax    
Email  rakeshuhs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ekta Sharma 
Designation  Post Graduate 
Affiliation  PT B.D. SHARMA UNIVERSITY OF HEALTH SCIENCE PGIMS ROHTAK 
Address  3rd floor,Department of Pharmacology, PGIMS, ROHTAK

Rohtak
HARYANA
124001
India 
Phone  9588166028  
Fax    
Email  ektasharma011296@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ekta Sharma 
Designation  Post Graduate 
Affiliation  PT B.D. Sharma PGIMS Rohtak 
Address  3rd floor,Department of Pharmacology, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9588166028  
Fax    
Email  ektasharma011296@gmail.com  
 
Source of Monetary or Material Support  
Pt B.D. Sharma PGIMS Rohtak 
 
Primary Sponsor  
Name  PT B.D Sharma UHS Rohtak 
Address  Pt B.D. Sharma UHS, Rohtak, Haryana 124001 
Type of Sponsor  Other [Pt B D Sharma UHS- Government] 
 
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 Ekta Sharma  Pt B.D. Sharma PGIMS Rohtak  Ground floor,Department of Psychiatry, Pt B.D. Sharma PGIMS ,ROHTAK ,Haryana124001
Rohtak
HARYANA 		 09588166028

ektasharma011296@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F42||Obsessive-compulsive disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fluvoxamine 50 mg once daily for 12 weeks initially and can be increased upto 250 mg, if required.  Assess efficacy using Y BOCS Scale and CGI scale at baseline,2,4,6, and 12 weeks. Safety Assessment using UKU scale and adverse drug monitoring at 2,4,6 and 12 weeks 
Comparator Agent  Tablet Fluvoxamine 50 mg once daily + tablet L-methyl tetrahydrofolate 7.5 mg once daily for 12 weeks  Assess efficacy using Y BOCS Scale and CGI scale at baseline,2,4,6, and 12 weeks. Safety Assessment using UKU scale and adverse drug monitoring at 2,4,6 and 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Age 18-65 years
2)Patient fulfilling the criteria of OCD as
per ICD-11 any severity YBOCS score more than
8.
3) Willing to participate and give
informed consent 
 
ExclusionCriteria 
Details  1) Current diagnosis of OCD with
psychotic features or any other
psychiatric diagnosis in the past
2) Patient with a history of any
chronic physical illness
3) Current psychoactive substance use
• Pregnant and lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Improvement in Y- BOCS scale
2. Improvement in CGI scale 		 Baseline,2,4,6 and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Number of patients who withdrew from study due to ADR’s of drugs.
2. Number of patients requiring augmentation of fluvoxamine therapy
3.Mean dose of fluvoxamine required in both groups 		 1.Safety assessment will be carried out for both the treatment groups at 2, 4, 6 and 12
weeks.
2.drug response at the end of 2,4,6 and 12 weeks 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   19/05/2024 
Date of Study Completion (India) 18/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 18/05/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Obsessive-compulsive disorder (OCD) is a disabling condition consisting of bothersome
intrusive thoughts that elicit a feeling of discomfort. The prevalence of OCD is on the rise,
according to current trends the global prevalence ranges from 1.6% to 2.3%.1 The
symptoms in 50% cases often first appear in childhood and adolescent. The average age of
onset is 19.5 years.2 The prevalence in India is approximately 1%3 and roughly 90% of
those with OCD have coexisting psychiatric diagnoses, most commonly are anxiety
disorders.2
OCD is characterized by significant impairment of cognitive-behavioral inhibition, which
is associated with cognitive processes evoking anxiety, along with an increased desire for
perfect control over the possible harm.3
As per International Classification of Diseases (ICD) 11 obsessive compulsive and related
disorders includes olfactory reference syndrome, body dysmorphic disorder, bodily
focused repetitive behaviour disorder, hoarding disorder, hypochondriasis.10
Selective Serotonin Reuptake Inhibitors (SSRIs) along with Exposure and Response
Prevention (ERP) are the cornerstones of treatment for OCD. The initial line of treatment
for OCD is SSRIs like sertraline, paroxetine, fluvoxamine, and fluoxetine.4
Fluvoxamine is effective in treating OCD, and was the first SSRI to be approved for this
use. It blocks reuptake of serotonin at the sodium-dependent serotonin transporter (SERT)
of the neuronal membrane, enhancing actions of serotonin on 5HT1A autoreceptors.7 The
initial daily dose of fluvoxamine is 50 mg and the dose is further increased to100 mg if a
patient shows no improvement after 2 weeks of initiation of treatment. The maximum dose
prescribed is upto 250 mg depending on the improvement.7
Folate plays an important role in carbon transfer metabolism (methylation), required for
the synthesis of serotonin and other monoamine neurotransmitters as well ascatecholamines.5 Low folate levels are associated with mental illnesses like primarily
affective and psychotic disorders.6
In resistant cases of OCD, L-methyl tetrahydrofolate has been evaluated to the augment the
effect of fluvoxamine. However, there is scarcity of data regarding the additional benefit
effect of L- methyl tetrahydrofolate and it will be important to see the effect of
fluvoxamine in OCD patient when L-methyl tetrahydrofolate is used as an augmentation
strategy from the start of treatment. Hence, the current study is planned to assess the
efficacy and safety of fluvoxamine alone and in combination with L- methyl
tetrahydrofolate as add on therapy in patients of OCD
 
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