Effect of Vitamin C Upon SSRI-treated OCD Patients

• Status: Recruiting
• Trial end date: 2019-02-10
• Target enrollment: 90
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Ascorbic Acid; Serotonin Uptake Inhibitors; Vitamins

Criteria

Inclusion Criteria:

• Patients with OCD diagnosed by Psychiatry Department of BSMMU.

• OCD patients fulfills Diagnostic criteria of DSM-5.

• Insufficient or depleted plasma Vitamin C level 0.2-0.39 mg/dl or 11-28 µmol/L.

• Patients with YBOCS score more than 14.

Exclusion Criteria:

• Any physical or systemic illness / handicaps.

• Alcohol or substance abuse or dependence.

• Patients with Diabetes, Malignancy, Renal or Hepatic diseases.

• Patients receiving antidepressants within last 2 months.

• Patients with other psychological disorder (such as schizophrenia, bipolar disorder).