Effect of Vitamin C Upon SSRI-treated OCD Patients
Status:
Recruiting
Trial end date:
2019-02-10
Target enrollment:
Participant gender:
Summary
Title:
Effect of Vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive
Compulsive Disorder (OCD) patients.
Purpose of the study:
This study aims to examine the effect of vitamin C upon Selective Serotonin Reuptake
Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients.
Method:
It will be a prospective type of interventional study to to assess the effects of vitamin C
along with SSRIs upon OCD patients. The study will be conducted in the Department of
Pharmacology and Department of Psychiatry, BSMMU, from September 2017 to February 2019. A
total of 90 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
45 patients who will receive only SSRIs orally daily and group B would consist of 45 patients
who will receive vitamin C, 500 mg BID orally daily along with SSRIs for 8 weeks. To see the
effects of Vitamin C, biochemical parameters of oxidative stress markers such as plasma
malondialdehyde (MDA), plasma reduced glutathione (GSH) and plasma vitamin C level will be
performed at baseline (before vitamin C administration) and 8 weeks after intervention. Along
with the biochemical parameters, Yale-Brown score of obsessive-compulsive disorders (Y-OCD)
would also be assessed by Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
Data collection and Statistical consideration:
Data would be analyzed by Scientific Package for Social Science (SPSS) and represented by
tables and figures as applicable. Significance level would be set at 0.05, 0.01 and 0.001.
Patient's data will be recorded in a predetermined data sheet.
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.
Phase:
Phase 2
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh