Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04482296 |
| Other study ID # |
BSMMU/2019/8875 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2019 |
| Est. completion date |
August 20, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Title:
Effect of zinc supplementation on depression in SSRIs-treated MDD patients.
Purpose: Depression is the single largest contributor to global disability as has been ranked
by WHO (2015), in humans including both male and female.Studies have suggested that
conventional presently available anti-depressive medicines are effective for one third to
one-half (19-34%) of the patients suffering from depression, leaving the rest of patients to
suffer from recurrence or incomplete cure. Researchers throughout the world are involved to
obtain new pharmacotherapy for the treatment of MDD. Zinc is an important micronutrient of
the human body which is implicated as an essential component in various systemic wellbeing
including the central nervous system.
Methods: The study would be randomized, double-blind, placebo-controlled prospective
interventional trial and it would be conducted in the Department of Pharmacology and in
collaboration with the Department of Psychiatry, BSMMU, from date of approval by the IRB to
August 2020. A total of 100 patients suffering from mild to moderate major depression will be
selected following to inclusion and exclusion criteria and serum Zinc levels will be
assessed. The diagnosis of patients suffering from MDD and the selection of drugs and dosage
would be performed by a senior professor of the Psychiatry department. After completing the
necessary formalities including the informed consent of the patients, the patient would
undergo a selected questionnaire (DASS-21) to assess his/her degree of severity of the
disease. The patients would be randomly allocated into two groups: group A (control group)
and B (intervention group). Group A would consist of 50 patients who will receive a placebo
with SSRIs for 8 weeks. Group B would consist of 50 patients who will receive SSRIs plus Zinc
sulfate (30mg/day) orally for 8 weeks, after which at follow up, the severity of depression
will be assessed. The blood sample will be collected to measure serum zinc level at baseline
and again after 8 weeks of therapeutic 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. The study has no potential risk to the patients. Confidentiality will
be strictly maintained.
Description:
Depression (MDD) is a major global health problem. The number of people suffering from major
depressive disorder was reported as around 300 million (about 4.4% of the world's population)
in 2015. The total number is assumed to increase to 18.4% from 2005 to 2015. Depression is
more common in females compared to males (female: male = 5.1:3.6). Years lived with a
disability are about 50 million people due to major depressive disorder and this disease has
been claimed to be a major cause of morbidity, mortality, and also suicidal death. In
Bangladesh, the prevalence of depressive disorder is about 4.1% and the percentage of total
years lived with a disability (DALY) is about 7.1%. Within this number, some people suffer
additionally from anxiety disorders and some suffer from both anxiety disorder and MDD.
However, MDD has been assumed to occupy the place of the second cause of disability by 2020,
and MDD, therefore, demands attention and alerts in clinical psychiatry. Depression impairs
quality of life at the level of personal, familial, and social aspects and in the severe
form, may lead to thoughts of committing suicide. Suicidal death (about 8,00000 per year)
have been reported throughout the world in recent reports and are increasing gradually.
Conventional antidepressants are the medicines used to treat MDD. Increasing 5HT
concentrations at the synapses of the amygdala, frontal cortex, or the limbic region by SSRI
or TCA or other drugs administration remains the primary object of therapy. About 19-34% of
MDD patients show a reasonable level of response to the SSRIs while about 15-50% of patients
show dissatisfactory response or recurrence. This fact is a subject of concern and invite
pharmacological intervention either in the form of adjunct drugs or new drug discoveries.
Recent researches have revealed that a significant role of zinc in MDD patients due to its
antidepressant effects. Some studies reported that there is no effect of zinc supplementation
on depression in MDD patients. Because of the conflicted reports, this study has been
designed to evaluate the effect of zinc supplementation on depression in MDD patients treated
with SSRI. Results of this study may be helpful to advocate the regular use of zinc
supplementation as an adjunct to SSRI therapy in MDD. The study would be randomized,
double-blind, placebo-controlled prospective interventional trial and it would be conducted
in the Department of Pharmacology and in collaboration with the Department of Psychiatry,
BSMMU, from the date of approval by the IRB to August 2020. A total of 100 patients suffering
from mild to moderate major depression will be selected following to inclusion and exclusion
criteria and serum Zinc levels will be assessed. The diagnosis of patients suffering from MDD
and the selection of drugs and dosage would be performed by a senior professor of the
Psychiatry department. After completing the necessary formalities including the informed
consent of the patients, the patient would undergo a selected questionnaire (DASS-21) to
assess his/her degree of severity of the disease. The patients would be randomly allocated
into two groups: group A (control group) and B (intervention group). Group A would consist of
50 patients who will receive a placebo with SSRIs for 8 weeks. Group B would consist of 50
patients who will receive SSRIs plus Zinc sulfate (30mg/day) orally for 8 weeks, after which
at follow up, the severity of depression will be assessed. The blood sample will be collected
to measure serum zinc level at baseline and again after 8 weeks of therapeutic intervention.
The regularity of medicine intake will be ensured over the telephone, counting the tablets,
and from the patient's compliance sheet. The study entails almost no potential risk to the
patients which will be explained to the patients together with the fact that he/she would be
free to leave the study at any time and that he/she would receive free of cost treatment in
case of any adverse reactions. Statistical analysis will be obtained by SPSS (Statistical
Package for Social Science). Results will be presented in tables and graphical figures as
applicable. Calculated 'p' value may suggest the level of significance (significant at p ≤
0.050). 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. The study has no potential risk to the patients.
Confidentiality will be strictly maintained.
