Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03754647
Status:
UNKNOWN
Last Update Posted:
2018-11-28
First Post:
2018-11-25
Brief Title:
Effect of Vitamin C Upon SSRI-treated OCD Patients
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Effect of Vitamin C Upon Selective Serotonin Reuptake Inhibitors-treated Obsessive Compulsive Disorder Patients
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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-BOCSData would be analyzed by Scientific Package for Social ScienceSPSS and represented by tables and figures as applicable Significance level would be set at 005 001 and 0001 Patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None