Clinical Trials Logo

Clinical Trial 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, Yale-Brown score of obsessive-compulsive disorders (Y-OCD) would be assessed by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at baseline (before vitamin C administration) and 8 weeks after intervention. Biochemical parameters of oxidative stress markers such as plasma malondialdehyde (MDA), plasma reduced glutathione (GSH) and plasma vitamin C level would also be performed at baseline (before vitamin C 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.


Clinical Trial Description

Obsessive compulsive disorder (OCD) is the fourth-most common mental disorder. The World Health Organization (WHO) estimated OCD to be among the top 10 causes of years lived with illness related disability by 2020. Various psychological, social, genetic and biochemical factors are presumed to be involved in the etiology of OCD. Researches so far have indicated that free radical induced injuries are involved in the pathology of OCD. A well-known source of antioxidant is Vitamin C, which is easily available, cheap and more powerful regarding antioxidant effects compared to many other natural sources of vitamin C. Until now little study has been performed to observe the effect of vitamin C administration concurrent to the Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of OCD. Therefore the present study has been designed to assess the effects of vitamin C along with SSRIs upon OCD patients. The study would be a prospective type of interventional study to 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 would 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. Comparison between the two groups will be performed through biochemical parameters of oxidative stress markers such as serum malondialdehyde (MDA), serum reduced glutathione (GSH) and serum vitamin C levels at baseline (before vitamin C administration) and 8 weeks after intervention by vitamin C. 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 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. 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. Hence, this study would be the first to examine the efficacy of vitamin C as an adjunct to SSRIs in the treatment of OCD. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03754647
Study type Interventional
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact Taslima Akter, MBBS
Phone 01738248318
Email taslimamostafij@gmail.com
Status Recruiting
Phase N/A
Start date December 14, 2017
Completion date February 10, 2019

See also
  Status Clinical Trial Phase
Completed NCT00523718 - Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder Phase 2
Completed NCT00215137 - Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder Phase 2
Recruiting NCT06050369 - Objective Characterizatoion of Repetitive Behaviors N/A
Withdrawn NCT03926546 - Individual Versus Group Exposure With Response Prevention (ERP) for the Treatment of Obsessive Compulsive Disorder (OCD) N/A
Recruiting NCT05712057 - Neurostimulation Versus Therapy for Problems With Emotions N/A
Not yet recruiting NCT03313622 - Locating Biomarkers in OCD Through Behavioral Tasks
Withdrawn NCT03842345 - DELPhI Evaluation of Psychiatric Conditions
Completed NCT02866422 - Development of an Instrument That Monitors Behaviors Associated With OCD N/A
Completed NCT01833442 - Randomized Controlled Meditation Trial for Treating OCD N/A
Recruiting NCT04904952 - Effect of N-acetylcysteine as Add on Therapy With SSRI in Moderate to Severe OCD Patients N/A
Completed NCT05981690 - Therapist Guided, Parent-led, Cognitive Behavioural Therapy (CBT) for Preadolescent Children With Obsessive Compulsive Disorder (OCD) N/A
Recruiting NCT02500888 - Evaluation of Capsulotomy by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder N/A
Recruiting NCT06244121 - Effect of Pyridoxine as Add-on Therapy in OCD Patients N/A
Recruiting NCT05580614 - Paired tVNS With ERP in OCD N/A
Active, not recruiting NCT03511534 - Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder N/A
Recruiting NCT05624528 - A Clinical Trial of Tolcapone in Obsessive Compulsive Disorder Phase 2
Recruiting NCT05881356 - Discovering Factors in the Clinical Study Journey of Patients With OCD
Recruiting NCT05359562 - How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD N/A
Recruiting NCT03459456 - Measuring Automated Behavioral Observations & Vocal Expressions (ABOVE)
Active, not recruiting NCT05930912 - Psychiatric Orders in Psychoanalytic Treatment of ASD