Covid19DALT-COVNCT04893668
Depression and Anxiety in Long Term Coronavirus Disease COVID-19
An observational study of Covid19 and Depression, run by Hasanuddin University at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Depression, Anxiety
- What is being tested?
- Depression and Anxiety
- How many people
- 165 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- Age minimum 18 years old
- For exposed group should be confirmed with RT-PCR
- Not being diagnosed by depression or anxiety prior to recruitment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Hasanuddin University Medical Research Center / HUMRC
Makassar, South Sulawesi, 90245
Bumi Herman, M.D, Ph.D, +62411586010, bumiherman@med.unhas.ac.id
Bumi Herman, M.D Ph.D
About this study
Official title: Depression and Anxiety in Long Term COVID 19. A Study in Neurotransmitter Impact of Severe Acute Respiratory Syndrome-Coronavirus 2 Infection.
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.
Read more
Objective:
- 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,
- 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.
Read the detailed 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:
- Effect Size: 0.15
- Type I error: 0.05
- Power of Study: 80%
- Number of Group: 2
- Repeated measurement: 3 times
- Correlation among Repeated Measures: 0.5
- Nonsphericity Correction: 1
- Initial Sample size: 75
Adjusted by clustering effect:
- Intraclass Correlation Coefficient = 0.05
- Number of people per cluster = 25
- Design Effect= 1 + 0.05(25-1) = 2.2
- Total sample size = 75 x 2.2 = 165 participants
Procedure:
- Participants will be assessed for eligibility
- 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)
- Sample Collection and assessment of QoL, DASS, PSQI on the first day
- Sample Collection and assessment of QoL, DASS, PSQI on day 60
- Sample Collection and assessment of QoL, DASS, PSQI on day 120
Variables
- Case Definition: Realtime Polymerase Chain Reaction (RT-PCR) and Cycle Threshold Value (CT)
- Degree of COVID 19 Symptom-based on World Health Organization Criteria (Asymptomatic, Mild, Moderate, Severe, Critical)
- Sociodemographic Variables (Age, Gender, Education, Income, Marital Status)
- Sleep Quality using Pittsburgh Sleep Quality Index (PSQI)
- Treatment of COVID: Antiviral, Antibiotic, Interleukin-6 Antagonist, Steroid, Plasma Convalescent, Ventilator, Human Intravenous Immunoglobulin, anticoagulant
- Chronic Disease including Diabetes Mellitus, Hypertension, Chronic Kidney Disease
- Medication that affects neurotransmitter level taken prior to recruitment.
- History of Smoking classified by Brinkmann Index.
- Body Mass Index
- Complete Blood Count
- Vaccination history
Outcome
- Dopamine Serum
- Serotonin Serum
- Prevalence of Anxiety, and Depression according to Diagnostic and Statistical Manual of Mental disorders (DSM) 5
Statistical analysis Basic Analysis: Intention to Treat analysis
- Linear Mixed Model for Neurotransmitter
- Generalized Estimating Equation for Prevalence of Anxiety and Depression
- Sensitivity analysis will be conducted, concerning the lost-to-follow up
- A subgroup analysis will be conducted, particularly the participants with specific comorbidities
- Conditions
- Covid19, Depression, Anxiety
- Being tested
- Depression, Anxiety
- Keywords
- Covid19, Serotonin, Dopamine, Depression, Anxiety
- Medical subject headings
- COVID-19, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DepressionOther
Any participants who develop depression symptoms according to DSM 5 criteria
AnxietyOther
Any participants who develop anxiety symptoms according to DSM 5 criteria
| Study group | Role | What they receive |
|---|---|---|
| Exposed with COVID 19 | The participant with confirmed RT-PCR Covid 19 at the beginning of the study Receives: Other: Depression; Other: Anxiety | |
| Unexposed with COVID 19 | The participant without confirmed RT-PCR Covid 19 at the beginning of the study until 6 month follow up period Receives: Other: Depression; Other: Anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Serotonin
The level of serotonin (5-hydroxytryptamine) measured from the blood serum with the normal range between 50 to 200 ng/mL
Measured: 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
Measured: Changes of Dopamine level from the baseline to 60 days and 120 days
Secondary outcomes (2)
Prevalence of Depression
Prevalence of depression defined in Diagnostic and Statistical Manual of Mental disorders fifth edition / DSM 5
Measured: changes of prevalence of depression from the baseline to 60 days and 120 days
Prevalence of Anxiety
Prevalence of Anxiety defined in Diagnostic and Statistical Manual of Mental disorders fifth edition / DSM 5
Measured: changes of prevalence of Anxiety from the baseline to 60 days and 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bumi Herman, Hasanuddin University
- Investigators
- Bumi Herman, M.D Ph.D, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893668
- Sponsor's protocol ID
- 1105211301
- Acronym
- DALT-COV
- Status last verified
- Jun 2021
- First submitted
- 11 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protocol, Statistical Analysis Plan and De-identified data will be shared accordingly
Publications
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.
PubMed 33428867Nataf 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.
PubMed 32246784Antonini 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.
PubMed 32347572Adhanom 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.
PubMed 32394569Basagana 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.
PubMed 20547587
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Anxiety in Long Term COVID 19. A Study in Neurotransmitter Impact of Severe Acute Respiratory Syndrome-Coronavirus 2 Infection.
- ClinicalTrials.gov ID
- NCT04893668
- Acronym / sponsor ID
- DALT-COV / 1105211301
- Conditions
- Covid19, Depression, Anxiety
- Keywords
- Covid19, Serotonin, Dopamine, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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,
- 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.
Detailed 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:
- Effect Size: 0.15
- Type I error: 0.05
- Power of Study: 80%
- Number of Group: 2
- Repeated measurement: 3 times
- Correlation among Repeated Measures: 0.5
- Nonsphericity Correction: 1
- Initial Sample size: 75
Adjusted by clustering effect:
- Intraclass Correlation Coefficient = 0.05
- Number of people per cluster = 25
- Design Effect= 1 + 0.05(25-1) = 2.2
- Total sample size = 75 x 2.2 = 165 participants
Procedure:
- Participants will be assessed for eligibility
- 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)
- Sample Collection and assessment of QoL, DASS, PSQI on the first day
- Sample Collection and assessment of QoL, DASS, PSQI on day 60
- Sample Collection and assessment of QoL, DASS, PSQI on day 120
Variables
- Case Definition: Realtime Polymerase Chain Reaction (RT-PCR) and Cycle Threshold Value (CT)
- Degree of COVID 19 Symptom-based on World Health Organization Criteria (Asymptomatic, Mild, Moderate, Severe, Critical)
- Sociodemographic Variables (Age, Gender, Education, Income, Marital Status)
- Sleep Quality using Pittsburgh Sleep Quality Index (PSQI)
- Treatment of COVID: Antiviral, Antibiotic, Interleukin-6 Antagonist, Steroid, Plasma Convalescent, Ventilator, Human Intravenous Immunoglobulin, anticoagulant
- Chronic Disease including Diabetes Mellitus, Hypertension, Chronic Kidney Disease
- Medication that affects neurotransmitter level taken prior to recruitment.
- History of Smoking classified by Brinkmann Index.
- Body Mass Index
- Complete Blood Count
- Vaccination history
Outcome
- Dopamine Serum
- Serotonin Serum
- Prevalence of Anxiety, and Depression according to Diagnostic and Statistical Manual of Mental disorders (DSM) 5
Statistical analysis Basic Analysis: Intention to Treat analysis
- Linear Mixed Model for Neurotransmitter
- Generalized Estimating Equation for Prevalence of Anxiety and Depression
- Sensitivity analysis will be conducted, concerning the lost-to-follow up
- A subgroup analysis will be conducted, particularly the participants with specific comorbidities
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed with COVID 19 | – | Other: Depression, Other: AnxietyThe participant with confirmed RT-PCR Covid 19 at the beginning of the study |
| Unexposed with COVID 19 | – | Other: Depression, Other: AnxietyThe participant without confirmed RT-PCR Covid 19 at the beginning of the study until 6 month follow up period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- Age minimum 18 years old
- For exposed group should be confirmed with RT-PCR
- Not being diagnosed by depression or anxiety prior to recruitment
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DepressionAny participants who develop depression symptoms according to DSM 5 criteria | Other | Exposed with COVID 19, Unexposed with COVID 19 |
| AnxietyAny participants who develop anxiety symptoms according to DSM 5 criteria | Other | Exposed with COVID 19, Unexposed with COVID 19 |
Primary outcome
Level of Serotonin
Time frame: Changes of Serotonin level from the baseline to 60 days and 120 days
The level of serotonin (5-hydroxytryptamine) measured from the blood serum with the normal range between 50 to 200 ng/mL
Level of Dopamine
Time frame: Changes of Dopamine level from the baseline to 60 days and 120 days
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
2 secondary outcomes
Prevalence of Depression
Time frame: changes of prevalence of depression from the baseline to 60 days and 120 days
Prevalence of Anxiety
Time frame: changes of prevalence of Anxiety from the baseline to 60 days and 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Background: PubMed 33428867Huang 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.
- Background: PubMed 32246784Nataf 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.
- Background: PubMed 32347572Antonini 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.
- Background: PubMed 32394569Adhanom 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.
- Background: PubMed 20547587Basagana 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.
- Individual participant dataSharing planned: Undecided. Protocol, Statistical Analysis Plan and De-identified data will be shared accordingly
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bumi Herman, M.D Ph.D principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Depression, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bumi Herman, M.D.Ph.D (+66638275008, bumiherman@med.unhas.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Serotonin (time frame: Changes of Serotonin level from the baseline to 60 days and 120 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893668, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.