Effect of Vitamin C Upon SSRI-treated OCD Patients

NCT03754647 | Unknown

• 1 other identifier: BSMMU/2018/3110
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

OCD

Keywords

Vitamin C; OCD; MDA; RBC Glutathione

Outcome Measures

Primary Outcomes (1)

• To examine the effect of vitamin C upon Selective Serotonin Reuptake Inhibitors (SSRIs) - treated Obsessive Compulsive Disorder patients.

  To assess the clinical improvement of OCD patients by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and compare plasma MDA, RBC glutathione, plasma vitamin C levels at baseline and after 8 weeks of treatment.

  8 weeks

Study Arms (2)

Patients receiving SSRIs

NO INTERVENTION

This group will be receive SSRIs only

Patients receiving Vitamin C with SSRIs

ACTIVE COMPARATOR

This group will be receive vitamin C (500mg) twice daily with SSRIs for 8 weeks

Dietary Supplement: Vitamin C

Interventions

Vitamin C DIETARY_SUPPLEMENT

One tablet of Vitamin C (500 mg) twice daily with SSRIs for 8 weeks

Patients receiving Vitamin C with SSRIs

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Taslima Akter, MBBS

CONTACT

01738248318; taslimamostafij@gmail.com

RAM Mostafizur Rashid, MBBS

CONTACT

01724840401; mostafizrmc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 27, 2018
• Study Start: December 14, 2017
• Primary Completion: February 10, 2019
• Study Completion: February 10, 2019
• Last Updated: November 28, 2018

Record last verified: 2018-11

Locations

BA (1)