Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06244121
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-28
Brief Title:
Effect of Pyridoxine as Add-on Therapy in OCD Patients
Sponsor:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Organization:
Bangabandhu Sheikh Mujib Medical University Dhaka Bangladesh
Study Overview
Official Title:
Effect of Pyridoxine as Add-on Therapy With Standard Treatment in Obsessive Compulsive Disorder Patients A Randomized Double-Blind Placebo-Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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 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 PharmacologyBSMMU 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 interventionafter 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
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 PharmacologyBSMMU 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 interventionafter 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
Detailed Description:
Obsessive-compulsive disorder OCD is the fourth most common mental disorder in Bangladesh and around the world Selective serotonin reuptake inhibitors SSRIs are commonly administered drugs for treating children and adolescents with OCD The treatment of this condition has remained unsatisfactory only 40-60 of patients with OCD respond to SSRIs and about 40 to 60 of patients with OCD do not completely respond to this drug Researchers throughout the world are involved to obtain new pharmacotherapy for the treatment of OCD A good number of evidences have proved that oxidative stress plays a significant role in the pathophysiology of OCDResearches so far have indicated that free radical induced injuries are involved in the pathology of OCDPyridoxine Vit B6 is a water soluble vitamin has anti oxidant effectsTherefore the present study has been designed to assess the effects of pyridoxine along with standard treatment upon OCD patients
Aim This proposed study is therefore an effort whether there is any role of Pyridoxine vit B6 adjuncts with standard treatment produce better improvement than standard treatment alone in OCD patients Method This study will be a randomized double-blind placebo-controlled trial that will be conducted in the department of pharmacology BSMMU in collaboration with the department of psychiatry BSMMU Dhaka from the day of approval by the IRB Institutional Review Board to July 2024 A total of 76 patients suffering from OCD will be selected according to inclusion and exclusion criteria The diagnosis of patients suffering from OCD and the selection of drug and dosage would be performed by a senior professor of the psychiatry department After completing the necessary formalities including informed consent of the patients the patient would undergo a selected questionnaire Yale-Brown Obsessive Scale Y-BOCS-10 to assess the severity of the disease The patients would be randomly allocated into two arms control and intervention Patients in the intervention arm would consist of 38 patients who will receive standard treatment plus tab pyridoxine 25 mg twice daily for 8 weeks On the other hand the control arm would consist of 38 patients who will receive standard treatment plus a placebo for 8 weeks The severity of symptoms will be assessed after 8 weeks follow-up Biochemical parameters of oxidative stress markers RBC glutathione plasma MDA will be measured at baseline and after 8 weeksAlong 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 at baseline and after 8 weeks The regularity of medicine intake will be ensured over the telephone and from the patients compliance sheet Statistical analysis will be obtained by SPSS statistical package for social science version 24 The calculated p value may suggest the level of significance significant at p005 Ethical consideration After approval from IRB Institutional Review Board every eligible patient will be informed about the intervention and the study objectives Patients will also be informed that they can participate or to withdraw at any time without compromising their medical care Patient confidentiality will be strictly maintained Patients personal data regarding the name age sex and other information will not be disclosed anywhere and will be used only for research purposes
Aim This proposed study is therefore an effort whether there is any role of Pyridoxine vit B6 adjuncts with standard treatment produce better improvement than standard treatment alone in OCD patients Method This study will be a randomized double-blind placebo-controlled trial that will be conducted in the department of pharmacology BSMMU in collaboration with the department of psychiatry BSMMU Dhaka from the day of approval by the IRB Institutional Review Board to July 2024 A total of 76 patients suffering from OCD will be selected according to inclusion and exclusion criteria The diagnosis of patients suffering from OCD and the selection of drug and dosage would be performed by a senior professor of the psychiatry department After completing the necessary formalities including informed consent of the patients the patient would undergo a selected questionnaire Yale-Brown Obsessive Scale Y-BOCS-10 to assess the severity of the disease The patients would be randomly allocated into two arms control and intervention Patients in the intervention arm would consist of 38 patients who will receive standard treatment plus tab pyridoxine 25 mg twice daily for 8 weeks On the other hand the control arm would consist of 38 patients who will receive standard treatment plus a placebo for 8 weeks The severity of symptoms will be assessed after 8 weeks follow-up Biochemical parameters of oxidative stress markers RBC glutathione plasma MDA will be measured at baseline and after 8 weeksAlong 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 at baseline and after 8 weeks The regularity of medicine intake will be ensured over the telephone and from the patients compliance sheet Statistical analysis will be obtained by SPSS statistical package for social science version 24 The calculated p value may suggest the level of significance significant at p005 Ethical consideration After approval from IRB Institutional Review Board every eligible patient will be informed about the intervention and the study objectives Patients will also be informed that they can participate or to withdraw at any time without compromising their medical care Patient confidentiality will be strictly maintained Patients personal data regarding the name age sex and other information will not be disclosed anywhere and will be used only for research purposes
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?:
None
Is an FDA AA801 Violation?:
None