Effect of Pyridoxine as Add-on Therapy in OCD Patients

NCT06244121 | Unknown

• 1 other identifier: BSMMU/2023/7593
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Effect of Pyridoxine as Add-on Therapy with Standard Treatment in Obsessive Compulsive Disorder Patients: A Randomized, Double-Blind, Placebo-Controlled Trial Purpose of the study: This study aims to examine the effect of Pyridoxine with standard treatment in Obsessive Compulsive Disorder patients. Method: It will be a prospective type of interventional study to to assess the effects of Pyridoxine along with standard treatment in OCD patients. The study will be conducted in the Department of Pharmacology,BSMMU and Department of Psychiatry, BSMMU, from September 2022 to July 2024. A total of 76 OCD patients will be selected according to inclusion and exclusion criteria. The patients will be divided randomly into 2 groups: group A and group B. Group A will consist of 38 patients who will receive tablet pyridoxine 25 mg twice daily with standard treatment and group B would consist of 38 patients who will receive placebo twice daily along with standard treatment for 8 weeks. To see the effects of pyridoxine, Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would be assessed by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at baseline (before pyridoxine administration) and 8 weeks after intervention(after pyridoxine administration). Biochemical parameters of oxidative stress markers such as plasma malondialdehyde (MDA), RBC glutathione (GSH) would be performed at baseline (before pyridoxine administration) and 8 weeks after intervention. Ethical consideration: The study will follow the principles of the Declaration of Helsinki and of the World Medical Assembly. Patients will be informed about the study in easy language and then informed consent will be taken. This study has no potential risk to the patients. Confidentiality will be strictly maintained.

Conditions

OCD

Keywords

Pyridoxine; OCD; RBC Glutathione; Plasma MDA; Vit B6

Outcome Measures

Primary Outcomes (1)

• To examine the effect of Pyridoxine as add on therapy with standard treatment in Obsessive Compulsive Disorder patients.

  To assess and compare the clinical improvement of OCD patients by Yale-Brown Obsessive Compulsive Scale (Y-BOCS),where minimum and maximum values are 0 (best) and 40 (worst) respectively, and compare plasma MDA in umol/L, RBC glutathione in mg/L levels at baseline and after 8 weeks of treatment.

  8 weeks

Study Arms (2)

Standard treatment with pyridoxine

EXPERIMENTAL

This group will receive standard treatment with pyridoxine 25 mg twice daily for 8 weeks

Drug: Pyridoxine

Standard treatment with placebo

PLACEBO COMPARATOR

This group will receive standard treatment with placebo 25 mg twice daily for 8 weeks

Drug: Placebo

Interventions

Pyridoxine DRUG

pyridoxine (Vitamin B6) will be given as an anti oxidant.

Standard treatment with pyridoxine

Placebo DRUG

Placebo will be given in control group

Standard treatment with placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with OCD diagnosed by Psychiatry Department of BSMMU.
• OCD patients fulfills Diagnostic criteria of DSM-5 (Diagnostic and Statistical Manual of Mental Disorders,5th Edition)

You may not qualify if:

• Patients with other psychological disorder
• Prior exposure to pyridoxine within last 2 months
• Pregnant and lactating mother
• Patients unwilling to participate or unwilling to give written consent

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Sumaiya Nousheen

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Interventions

Pyridoxine

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Sumaiya Nousheen

CONTACT

01747585554; pinki12vnsc@gmail.com

Sheykh Ahmed

CONTACT

01515218336; sheykhahmed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (participant, investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 6, 2024
• Study Start: June 3, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 30, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-01

Locations

BA (1)