Depression and Anxiety in Long Term Coronavirus Disease COVID-19

Depression Clinical Trial

— DALT-COV  

Official title:

Depression and Anxiety in Long Term COVID 19. A Study in Neurotransmitter Impact of Severe Acute Respiratory Syndrome-Coronavirus 2 Infection.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04893668
• Other study ID #: 1105211301
• Status: Not yet recruiting
• Start date: October 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2021
• Source: Hasanuddin University
• Contact: Bumi Herman, M.D.Ph.D
• Phone: +66638275008
• Email: bumiherman[@]med.unhas.ac.id
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background :

Depression and Anxiety are linked to COVID (Coronavirus Disease)-19 long-term impact through several mechanisms. The possible way is the alteration of neurotransmitter regulation from the interaction of severe acute respiratory syndrome -Coronavirus-2 (SARS-COV2) with Angiotensin-Converting Enzyme 2 (ACE2) receptor, and Dopa Decarboxylase (DDC), an enzyme that associated with the production of dopamine, serotonin, and other neurotransmitters. However, some arguments exist that depression and anxiety occur naturally due to external stressors, as the impact of public health measures, and not associated with physiological changes due to viral infection.

Objective:

1. This study aims to identify whether the patient discharged after COVID 19 treatment has significant changes in serotonin and dopamine level which might induce depression and anxiety internally and,

2. To distinguish external etiologies that might induce depression and anxiety such as social isolation and stress due to public health restriction.

Method:

A prospective longitudinal study of people with the interest exposure is COVID 19 and the primary outcome is Depression, Anxiety, and Neurotransmitter level

Hypothesis:

People with a previous infection of COVID 19 have a significant difference in neurotransmitter level over time and compared to non exposed group and a higher prevalence of anxiety and depression.

Description:

Method :

Prospective Longitudinal study for 6 months. with both exposed and unexposed group

Target population :

A cohort of the population in multiple centers (3 centers)

Sample Size Calculation with Longitudinal study formula:

1. Effect Size: 0.15

2. Type I error: 0.05

3. Power of Study: 80%

4. Number of Group: 2

5. Repeated measurement: 3 times

6. Correlation among Repeated Measures: 0.5

7. Nonsphericity Correction: 1

8. Initial Sample size: 75

Adjusted by clustering effect:

1. Intraclass Correlation Coefficient = 0.05

2. Number of people per cluster = 25

3. Design Effect= 1 + 0.05(25-1) = 2.2

4. Total sample size = 75 x 2.2 = 165 participants

Procedure:

1. Participants will be assessed for eligibility

2. Screening for Depression, Anxiety, and Stress using Depression Anxiety Stress Scale (DASS) Questionnaire. Health-Related Quality of Life (QoL) and Pittsburgh Sleep Quality Index (PSQI)

3. Sample Collection and assessment of QoL, DASS, PSQI on the first day

4. Sample Collection and assessment of QoL, DASS, PSQI on day 60

5. Sample Collection and assessment of QoL, DASS, PSQI on day 120

Variables

1. Case Definition: Realtime Polymerase Chain Reaction (RT-PCR) and Cycle Threshold Value (CT)

2. Degree of COVID 19 Symptom-based on World Health Organization Criteria (Asymptomatic, Mild, Moderate, Severe, Critical)

3. Sociodemographic Variables (Age, Gender, Education, Income, Marital Status)

4. Sleep Quality using Pittsburgh Sleep Quality Index (PSQI)

5. Treatment of COVID: Antiviral, Antibiotic, Interleukin-6 Antagonist, Steroid, Plasma Convalescent, Ventilator, Human Intravenous Immunoglobulin, anticoagulant

6. Chronic Disease including Diabetes Mellitus, Hypertension, Chronic Kidney Disease

7. Medication that affects neurotransmitter level taken prior to recruitment.

8. History of Smoking classified by Brinkmann Index.

9. Body Mass Index

10. Complete Blood Count

11. Vaccination history

Outcome

1. Dopamine Serum

2. Serotonin Serum

3. Prevalence of Anxiety, and Depression according to Diagnostic and Statistical Manual of Mental disorders (DSM) 5

Statistical analysis Basic Analysis: Intention to Treat analysis

1. Linear Mixed Model for Neurotransmitter

2. Generalized Estimating Equation for Prevalence of Anxiety and Depression

3. Sensitivity analysis will be conducted, concerning the lost-to-follow up

4. A subgroup analysis will be conducted, particularly the participants with specific comorbidities

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: June 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age minimum 18 years old

2. For exposed group should be confirmed with RT-PCR

3. Not being diagnosed by depression or anxiety prior to recruitment

Exclusion Criteria:

1. The unexposed participants will be excluded from the unexposed group if contracted with the virus within the 6-month observation.

2. Patient falls into critical condition and it is unlikely to attend at least one follow-up measurement

3. Patient refuses to continue observation

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Covid19
• Depression
• Depressive Disorder

Intervention

Other:
• Depression
Any participants who develop depression symptoms according to DSM 5 criteria
• Anxiety
Any participants who develop anxiety symptoms according to DSM 5 criteria

Locations

Country	Name	City	State
Indonesia	Hasanuddin University Medical Research Center / HUMRC	Makasar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Hasanuddin University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

Adhanom Ghebreyesus T. Addressing mental health needs: an integral part of COVID-19 response. World Psychiatry. 2020 Jun;19(2):129-130. doi: 10.1002/wps.20768. — View Citation

Antonini A, Leta V, Teo J, Chaudhuri KR. Outcome of Parkinson's Disease Patients Affected by COVID-19. Mov Disord. 2020 Jun;35(6):905-908. doi: 10.1002/mds.28104. Epub 2020 May 28. — View Citation

Basagaña X, Xiaomei Liao, Spiegelman D. Power and sample size calculations for longitudinal studies estimating a main effect of a time-varying exposure. Stat Methods Med Res. 2011 Oct;20(5):471-87. doi: 10.1177/0962280210371563. Epub 2010 Jun 14. — View Citation

Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8. — View Citation

Nataf S. An alteration of the dopamine synthetic pathway is possibly involved in the pathophysiology of COVID-19. J Med Virol. 2020 Oct;92(10):1743-1744. doi: 10.1002/jmv.25826. Epub 2020 Apr 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Serotonin	The level of serotonin (5-hydroxytryptamine) measured from the blood serum with the normal range between 50 to 200 ng/mL	Changes of Serotonin level from the baseline to 60 days and 120 days
Primary	Level of Dopamine	The level of serotonin (4- (2-aminoethyl) benzene-1, 2-diol) measured from the blood serum with the normal range between 0 to 30 pg/mL	Changes of Dopamine level from the baseline to 60 days and 120 days
Secondary	Prevalence of Depression	Prevalence of depression defined in Diagnostic and Statistical Manual of Mental disorders fifth edition / DSM 5	changes of prevalence of depression from the baseline to 60 days and 120 days
Secondary	Prevalence of Anxiety	Prevalence of Anxiety defined in Diagnostic and Statistical Manual of Mental disorders fifth edition / DSM 5	changes of prevalence of Anxiety from the baseline to 60 days and 120 days