Effect of Vitamin D Administration Along With SSRIs in Patients With Major Depressive Disorder

MDD Clinical Trial

Official title:

Effect of Vitamin D Administration Along With Selective Serotonin Reuptake Inhibitors (SSRIs) in Patients With Major Depressive Disorder (MDD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03754712
• Other study ID #: No. BSMMU /2018/2964
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: November 2018
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: Tanzina Afrin, MBBS
• Phone: 01796372338
• Email: Tanzina.afrin800[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Several studies suggested low serum levels of vitamin D have been associated with depression. So, the present study is designed to investigate the effect of vitamin D administration along with SSRIs in patients with MDD.

Description:

Depression is a major global health problem. Major depression was ranked as the third leading cause of the global burden of diseases in 2004 and is supposed to occupy the first place by 2030. Major depression is a complex and multifactorial symptom-complex while dysfunctions in various endocrine axes may be independent risk factors in the development of the affective illness. Some recent observations indicate a significant role of vitamin D regarding mood. Vitamin D3 receptors have been found in cerebral cortex, cerebellum, and the limbic system. The active form of vitamin D on the nervous system is associated with modifying the production and release of neurotrophic factors such as nerve growth factor (NGF) which is essential for neuron differentiation, as well as increasing the levels of glial cell line derived neurotrophic factor (GDNF). Vitamin D influence the expression of genes associated GABA-ergic neurotransmission. It also stimulates the expression of tyrosine hydroxylase which is responsible for catecholamines biosynthesis. Lately, positive influences of vitamin D upon patients suffering from MDD have been suggested. This area require further attention and confirmation as little work has been carried out in this field. So, the present study is an attempt to investigate the effect of vitamin D administration along with SSRIs in patients with MDD. The study would be a interventional one to be conducted in the department of Pharmacology and in the department of psychiatry, BSMMU. A total of 90 patients suffering from major depression will be selected according to inclusion and exclusion criteria. The diagnosis of patients suffering from major depression and the selection of SSRIs would be performed by medical officer of the Psychiatry department. After completing necessary formalities including informed consent of the patients, patient's data will be collected to measure baseline complaints of depression. The patients would be divided into two groups: group A and B. Group A would consist of 45 patients who will receive only SSRIs and Group B would consist of 45 patients who will receive SSRIs plus vitamin D (2000IU) orally once daily. Blood sample will be collected to measure serum vitamin D and calcium level at baseline. Then again blood sample will be collected to measure serum vitamin D level after 8 weeks of vitamin D administration. Regularity of medicine intake will be ensured over telephone, pill count, and from the patient's compliance sheet. The study has entails almost no potential risk to the patients. Patients would have every right to quit the experimental procedure any time during the experimentations if they desire each. However, it will be explained to them that the results of the present study may offer better prospects for similar patients in future, and that the present experimentations would carry no potential risk towards their health or their lives provided they strictly follow the instructions conducted to them.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 28, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with MDD

• patients with PHQ - 9 score more than 10

• serum vitamin D less than 30 ng/ml

• Serum calcium level 8.5-10.5 mg/dl

Exclusion Criteria:

• Patients receiving antidepressant and dietary supplement with in last two months.

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

• Patients with parathyroid disease, thyroid disease, liver and kidney disease

• Patients with Diabetes mellitus

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• MDD

Intervention

Dietary Supplement:
• Vitamin D3
Dietary supplement : Vitamin D3 one tablet of vitamin D3 (2000IU) per day for 8 weeks

Locations

Country	Name	City	State
Bangladesh	BSMMU	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of depression	Changes in severity of depression will be measured through the Patient Health Questionnaire - 9 (PHQ - 9) score at baseline and at 8 weeks	8 weeks