Depression and Anxiety in Long Term Coronavirus Disease COVID-19
DALT-COV
1 other identifier
observational
165
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJune 7, 2021
June 1, 2021
6 months
May 11, 2021
June 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Prevalence of Depression
changes of prevalence of depression from the baseline to 60 days and 120 days
Prevalence of Anxiety
changes of prevalence of Anxiety from the baseline to 60 days and 120 days
Study Arms (2)
Exposed with COVID 19
The participant with confirmed RT-PCR Covid 19 at the beginning of the study
Unexposed with COVID 19
The participant without confirmed RT-PCR Covid 19 at the beginning of the study until 6 month follow up period
Interventions
Any participants who develop depression symptoms according to DSM 5 criteria
Any participants who develop anxiety symptoms according to DSM 5 criteria
Eligibility Criteria
Three clusters will be appointed as the study center. The level of the cluster is at the municipality level where participants will be recruited consecutively
You may qualify if:
- Age minimum 18 years old
- For exposed group should be confirmed with RT-PCR
- Not being diagnosed by depression or anxiety prior to recruitment
You may not qualify if:
- The unexposed participants will be excluded from the unexposed group if contracted with the virus within the 6-month observation.
- Patient falls into critical condition and it is unlikely to attend at least one follow-up measurement
- Patient refuses to continue observation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hasanuddin University Medical Research Center / HUMRC
Makassar, South Sulawesi, 90245, Indonesia
Related Publications (5)
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.
PMID: 33428867BACKGROUNDNataf 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. No abstract available.
PMID: 32246784BACKGROUNDAntonini 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. No abstract available.
PMID: 32347572BACKGROUNDAdhanom 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. No abstract available.
PMID: 32394569BACKGROUNDBasagana 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.
PMID: 20547587BACKGROUND
Biospecimen
Blood Sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bumi Herman, M.D Ph.D
Chulalongkorn University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
May 11, 2021
First Posted
May 19, 2021
Study Start
October 1, 2021
Primary Completion
April 1, 2022
Study Completion
June 1, 2022
Last Updated
June 7, 2021
Record last verified: 2021-06