Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-02-10 @ 1:06 AM
Study NCT ID:
NCT04893668
Status:
UNKNOWN
Last Update Posted:
2021-06-07
First Post:
2021-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression and Anxiety in Long Term Coronavirus Disease COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Blood Sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-03', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Serotonin', 'timeFrame': 'Changes of Serotonin level from the baseline to 60 days and 120 days', 'description': 'The level of serotonin (5-hydroxytryptamine) measured from the blood serum with the normal range between 50 to 200 ng/mL'}, {'measure': 'Level of Dopamine', 'timeFrame': 'Changes of Dopamine level from the baseline to 60 days and 120 days', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Prevalence of Depression', 'timeFrame': 'changes of prevalence of depression from the baseline to 60 days and 120 days', 'description': 'Prevalence of depression defined in Diagnostic and Statistical Manual of Mental disorders fifth edition / DSM 5'}, {'measure': 'Prevalence of Anxiety', 'timeFrame': 'changes of prevalence of Anxiety from the baseline to 60 days and 120 days', 'description': 'Prevalence of Anxiety defined in Diagnostic and Statistical Manual of Mental disorders fifth edition / DSM 5'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid19', 'Serotonin', 'Dopamine', 'Depression', 'Anxiety'], 'conditions': ['Covid19', 'Depression', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '33428867', 'type': 'BACKGROUND', '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.'}, {'pmid': '32246784', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '32347572', 'type': 'BACKGROUND', '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. No abstract available."}, {'pmid': '32394569', 'type': 'BACKGROUND', 'citation': '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. No abstract available.'}, {'pmid': '20547587', 'type': 'BACKGROUND', 'citation': 'Basagana 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.'}]}, 'descriptionModule': {'briefSummary': 'Background :\n\nDepression 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.\n\nObjective:\n\n1. 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,\n2. To distinguish external etiologies that might induce depression and anxiety such as social isolation and stress due to public health restriction.\n\nMethod:\n\nA prospective longitudinal study of people with the interest exposure is COVID 19 and the primary outcome is Depression, Anxiety, and Neurotransmitter level\n\nHypothesis:\n\nPeople 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.', 'detailedDescription': 'Method :\n\nProspective Longitudinal study for 6 months. with both exposed and unexposed group\n\nTarget population :\n\nA cohort of the population in multiple centers (3 centers)\n\nSample Size Calculation with Longitudinal study formula:\n\n1. Effect Size: 0.15\n2. Type I error: 0.05\n3. Power of Study: 80%\n4. Number of Group: 2\n5. Repeated measurement: 3 times\n6. Correlation among Repeated Measures: 0.5\n7. Nonsphericity Correction: 1\n8. Initial Sample size: 75\n\nAdjusted by clustering effect:\n\n1. Intraclass Correlation Coefficient = 0.05\n2. Number of people per cluster = 25\n3. Design Effect= 1 + 0.05(25-1) = 2.2\n4. Total sample size = 75 x 2.2 = 165 participants\n\nProcedure:\n\n1. Participants will be assessed for eligibility\n2. 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)\n3. Sample Collection and assessment of QoL, DASS, PSQI on the first day\n4. Sample Collection and assessment of QoL, DASS, PSQI on day 60\n5. Sample Collection and assessment of QoL, DASS, PSQI on day 120\n\nVariables\n\n1. Case Definition: Realtime Polymerase Chain Reaction (RT-PCR) and Cycle Threshold Value (CT)\n2. Degree of COVID 19 Symptom-based on World Health Organization Criteria (Asymptomatic, Mild, Moderate, Severe, Critical)\n3. Sociodemographic Variables (Age, Gender, Education, Income, Marital Status)\n4. Sleep Quality using Pittsburgh Sleep Quality Index (PSQI)\n5. Treatment of COVID: Antiviral, Antibiotic, Interleukin-6 Antagonist, Steroid, Plasma Convalescent, Ventilator, Human Intravenous Immunoglobulin, anticoagulant\n6. Chronic Disease including Diabetes Mellitus, Hypertension, Chronic Kidney Disease\n7. Medication that affects neurotransmitter level taken prior to recruitment.\n8. History of Smoking classified by Brinkmann Index.\n9. Body Mass Index\n10. Complete Blood Count\n11. Vaccination history\n\nOutcome\n\n1. Dopamine Serum\n2. Serotonin Serum\n3. Prevalence of Anxiety, and Depression according to Diagnostic and Statistical Manual of Mental disorders (DSM) 5\n\nStatistical analysis Basic Analysis: Intention to Treat analysis\n\n1. Linear Mixed Model for Neurotransmitter\n2. Generalized Estimating Equation for Prevalence of Anxiety and Depression\n3. Sensitivity analysis will be conducted, concerning the lost-to-follow up\n4. A subgroup analysis will be conducted, particularly the participants with specific comorbidities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age minimum 18 years old\n2. For exposed group should be confirmed with RT-PCR\n3. Not being diagnosed by depression or anxiety prior to recruitment\n\nExclusion Criteria:\n\n1. The unexposed participants will be excluded from the unexposed group if contracted with the virus within the 6-month observation.\n2. Patient falls into critical condition and it is unlikely to attend at least one follow-up measurement\n3. Patient refuses to continue observation'}, 'identificationModule': {'nctId': 'NCT04893668', 'acronym': 'DALT-COV', 'briefTitle': 'Depression and Anxiety in Long Term Coronavirus Disease COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Hasanuddin University'}, 'officialTitle': 'Depression and Anxiety in Long Term COVID 19. A Study in Neurotransmitter Impact of Severe Acute Respiratory Syndrome-Coronavirus 2 Infection.', 'orgStudyIdInfo': {'id': '1105211301'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed with COVID 19', 'description': 'The participant with confirmed RT-PCR Covid 19 at the beginning of the study', 'interventionNames': ['Other: Depression', 'Other: Anxiety']}, {'label': 'Unexposed with COVID 19', 'description': 'The participant without confirmed RT-PCR Covid 19 at the beginning of the study until 6 month follow up period', 'interventionNames': ['Other: Depression', 'Other: Anxiety']}], 'interventions': [{'name': 'Depression', 'type': 'OTHER', 'description': 'Any participants who develop depression symptoms according to DSM 5 criteria', 'armGroupLabels': ['Exposed with COVID 19', 'Unexposed with COVID 19']}, {'name': 'Anxiety', 'type': 'OTHER', 'description': 'Any participants who develop anxiety symptoms according to DSM 5 criteria', 'armGroupLabels': ['Exposed with COVID 19', 'Unexposed with COVID 19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90245', 'city': 'Makassar', 'state': 'South Sulawesi', 'country': 'Indonesia', 'contacts': [{'name': 'Bumi Herman, M.D, Ph.D', 'role': 'CONTACT', 'email': 'bumiherman@med.unhas.ac.id', 'phone': '+62411586010'}, {'name': 'Bumi Herman, M.D Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Firman Hasan, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karina Patricia, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hasanuddin University Medical Research Center / HUMRC', 'geoPoint': {'lat': -5.14861, 'lon': 119.43194}}], 'centralContacts': [{'name': 'Bumi Herman, M.D.Ph.D', 'role': 'CONTACT', 'email': 'bumiherman@med.unhas.ac.id', 'phone': '+66638275008'}], 'overallOfficials': [{'name': 'Bumi Herman, M.D Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Protocol, Statistical Analysis Plan and De-identified data will be shared accordingly'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasanuddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Bumi Herman', 'investigatorAffiliation': 'Hasanuddin University'}}}}