Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
149 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-09-16
Study Completion Date
2023-02-22
Brief Summary
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A randomized, double-blinded, placebo-controlled trial will be conducted to evaluate vortioxetine, an antidepressant with established pro-cognitive properties, for the treatment of cognitive deficits which develop during or after an infection consistent with COVID-19, continue for 2+ months, and are not explained by an alternative diagnosis (i.e., post-COVID-19 condition). Participants (aged 18-64 years) will receive vortioxetine (10-20 mg) or placebo for 8 weeks. Participants 65+ years will receive vortioxetine (5-10 mg) or placebo for 8 weeks. Changes in cognitive functioning from baseline to endpoint (week 8) will be assessed via the Digit Symbol Substitution Test (DSST). Study visits may be conducted remotely (e.g. via Zoom, by telephone), and/or in-person.
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Detailed Description
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A significant percentage of individuals who have recovered from acute COVID-19 infection present with unabating, non-specific, distressing, and functionally impairing symptoms (i.e., post-COVID-19 condition). Commonly reported symptoms include, but are not limited to, cognitive impairment (e.g., "brain fog"), fatigue, apathy, depression, anxiety, insomnia, anergia, and loss of appetite. Toward the aim of identifying a common nomenclature and case definition, the World Health Organization (WHO) has recently proposed the moniker 'post COVID-19 condition'. It is estimated that approximately 10-30% of persons infected with COVID-19 experience characteristic symptoms persisting for more than 12 weeks following documentation of positive COVID-19 diagnosis.
Consensus exists that the phenomenology of post-COVID-19 condition is subserved by disturbance in immune-inflammatory systems. Currently, no treatment is identified as safe and effective for post-COVID-19 condition. A candidate treatment for post-COVID-19 condition should be capable of improving measures of cognitive function (i.e., objective and subjective), motivation and energy, as well as reducing fatigue. The rationale for prioritizing cognition as a primary therapeutic target is based on a concatenation of study results reporting that cognitive complaints/deficits and fatigue are some of the most common and debilitating features of post-COVID-19 condition. Preliminary evidence suggests that some antidepressants (e.g., SSRIs) are capable of reducing respiratory complications secondary to COVID-19 via putative mechanisms including, but not limited to, sigma-1 agonism and acid sphingomyelinase.
Vortioxetine is established as pro-cognitive, as evidenced by significant improvement on both subjective and objective measures. Vortioxetine is also documented to improve anticipatory and consummatory measures of reward function/anhedonia, improve general functioning, and measures of motivation and energy. Moreover, vortioxetine is not associated with emotional blunting and has preliminary evidence of improving sleep behaviour and circadian rhythms. The candidacy of vortioxetine as an effective treatment for post-COVID-19 condition is also strengthened by evidence indicating that vortioxetine exerts modulatory effects on cellular and cytokine systems known to be activated in persons with post-COVID-19 condition. Herein, we hypothesize that vortioxetine will be more effective than placebo in the treatment of cognitive impairment in persons with post-COVID-19 condition.
Consensus exists that the phenomenology of post-COVID-19 condition is subserved by disturbance in immune-inflammatory systems. Currently, no treatment is identified as safe and effective for post-COVID-19 condition. A candidate treatment for post-COVID-19 condition should be capable of improving measures of cognitive function (i.e., objective and subjective), motivation and energy, as well as reducing fatigue. The rationale for prioritizing cognition as a primary therapeutic target is based on a concatenation of study results reporting that cognitive complaints/deficits and fatigue are some of the most common and debilitating features of post-COVID-19 condition. Preliminary evidence suggests that some antidepressants (e.g., SSRIs) are capable of reducing respiratory complications secondary to COVID-19 via putative mechanisms including, but not limited to, sigma-1 agonism and acid sphingomyelinase.
Vortioxetine is established as pro-cognitive, as evidenced by significant improvement on both subjective and objective measures. Vortioxetine is also documented to improve anticipatory and consummatory measures of reward function/anhedonia, improve general functioning, and measures of motivation and energy. Moreover, vortioxetine is not associated with emotional blunting and has preliminary evidence of improving sleep behaviour and circadian rhythms. The candidacy of vortioxetine as an effective treatment for post-COVID-19 condition is also strengthened by evidence indicating that vortioxetine exerts modulatory effects on cellular and cytokine systems known to be activated in persons with post-COVID-19 condition. Herein, we hypothesize that vortioxetine will be more effective than placebo in the treatment of cognitive impairment in persons with post-COVID-19 condition.
Conditions
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Post-COVID-19 Condition
Post-COVID-19 Syndrome
Cognitive Impairment
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Vortioxetine
Participants aged 18-64 years: start at 10 mg vortioxetine once daily for the first 2 weeks, then dosed up to 20 mg vortioxetine once daily for weeks 2-8.
Participants aged 65+ years: start at 5 mg vortioxetine once daily for the first 2 weeks, then dosed up to 10 mg vortioxetine once daily for weeks 2-8.
Group Type
EXPERIMENTAL
Vortioxetine
Intervention Type
DRUG
Participants aged 18-64 years receiving vortioxetine will be provided 10 mg/day on days 1-14 of the treatment period, and will be titrated to 20 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 20 mg/day, unless adjudicated otherwise by a study clinician.
Per product monograph, participants aged 65+ years receiving vortioxetine will be provided 5 mg/day on days 1-14 of the treatment period, and will be titrated to 10 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 10 mg/day, unless adjudicated otherwise by a study clinician.
Placebo
Placebo capsule taken once daily for weeks 0-8.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
A placebo pill will be taken once daily.
Interventions
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Vortioxetine
Participants aged 18-64 years receiving vortioxetine will be provided 10 mg/day on days 1-14 of the treatment period, and will be titrated to 20 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 20 mg/day, unless adjudicated otherwise by a study clinician.
Per product monograph, participants aged 65+ years receiving vortioxetine will be provided 5 mg/day on days 1-14 of the treatment period, and will be titrated to 10 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 10 mg/day, unless adjudicated otherwise by a study clinician.
Intervention Type
DRUG
Placebo
A placebo pill will be taken once daily.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Age 18+
* Meets WHO-defined post-COVID-19 condition (WHO definition: 'Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, cognitive dysfunction but also others\* and generally have an impact on everyday functioning. Symptoms may be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness. Symptoms may also fluctuate or relapse over time.') To ensure the above criteria is met, participants will only be included in the study if they meet all eligibility criteria more than 12 weeks from the onset of their acute Covid-19 symptoms or positive PCR/antigen test.
* Documented history of SARS-CoV-2 infection (positive PCR/antigen test during acute illness OR clinical diagnosis by physician during or after the acute illness).
* Subjective cognitive complaints as detected by the Perceived Deficits Questionnaire (PDQ)-5.
* Ability to provide written informed consent.
* Resident of Canada.
* Meets WHO-defined post-COVID-19 condition (WHO definition: 'Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, cognitive dysfunction but also others\* and generally have an impact on everyday functioning. Symptoms may be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness. Symptoms may also fluctuate or relapse over time.') To ensure the above criteria is met, participants will only be included in the study if they meet all eligibility criteria more than 12 weeks from the onset of their acute Covid-19 symptoms or positive PCR/antigen test.
* Documented history of SARS-CoV-2 infection (positive PCR/antigen test during acute illness OR clinical diagnosis by physician during or after the acute illness).
* Subjective cognitive complaints as detected by the Perceived Deficits Questionnaire (PDQ)-5.
* Ability to provide written informed consent.
* Resident of Canada.
Exclusion Criteria
* Current symptoms are fully explained by major depressive disorder or bipolar disorder.
* Pre-existing conditions that may cause cognitive impairment, or symptoms similar to those seen in post-COVID-19 condition (e.g., major neurocognitive disorder, schizophrenia, chronic fatigue syndrome \[CFS\]/ encephalitis meningitis \[EM\]), as assessed by Mini International Neuropsychiatric Interview (MINI) 7.0.2.
* Inability to follow study procedures.
* Known intolerance to vortioxetine and/or prior trial of vortioxetine with demonstrated inefficacy.
* If participants are currently taking other antidepressants, they will be asked to discontinue the antidepressant for 2-4 weeks in order to participate in the study.
* Patients on other antidepressants are allowed to participate only if the antidepressant is prescribed at subtherapeutic doses for a primary indication other than mood disorders. Participants will be made aware in the consent form that the combination of the two antidepressants would be considered investigational and that the safety/efficacy profiles are unknown.
* Current alcohol or substance use disorder.
* Inability to provide consent.
* Current alcohol and/or substance use disorder as confirmed by the M.I.N.I 7.0.2.
* Presence of comorbid psychiatric disorder that is a primary focus of clinical concern as confirmed by the M.I.N.I. 7.0.2.
* Medications approved and/or employed off-label for cognitive dysfunction (e.g., psychostimulants).
* Any medication for a general medical disorder that, in the opinion of the investigator, may affect cognitive function.
* Use of benzodiazepines within 12 hours of cognitive assessments.
* Consumption of alcohol within 8 hours of cognitive assessments.
* Physical, cognitive, or language impairments sufficient to adversely affect data derived from cognitive assessments.
* Diagnosed reading disability or dyslexia.
* Clinically significant learning disorder by history.
* Electroconvulsive therapy (ECT) in the last 6 months.
* History of moderate or severe head trauma (e.g., loss of consciousness for \>1 hour), other neurological disorders, or unstable systemic medical diseases that in the opinion of the investigator are likely to affect the central nervous system.
* Pregnant and/or breastfeeding.
* Received investigational agents as part of a separate study within 30 days of the screening visit.
* Actively suicidal/presence of suicidal ideation or evaluated as being at suicide risk (as per clinical judgment).
* Currently receiving treatment with Monoamine Oxidase Inhibitors (MAOIs) antidepressants, antibiotics such as linezolid, or intravenous methylene blue.
* Previous hypersensitivity reaction to vortioxetine or any components of the formulation. Angioedema has been reported in patients treated with vortioxetine.
* Serotonin syndrome.
* Abnormal bleeding.
* Previous history of mania/hypomania.
* Angle closure glaucoma.
* Hyponatremia.
* Moderate hepatic impairment.
* Active seizure disorder/epilepsy, not controlled by medication
* Presence of any unstable medical conditions.
* Pre-existing conditions that may cause cognitive impairment, or symptoms similar to those seen in post-COVID-19 condition (e.g., major neurocognitive disorder, schizophrenia, chronic fatigue syndrome \[CFS\]/ encephalitis meningitis \[EM\]), as assessed by Mini International Neuropsychiatric Interview (MINI) 7.0.2.
* Inability to follow study procedures.
* Known intolerance to vortioxetine and/or prior trial of vortioxetine with demonstrated inefficacy.
* If participants are currently taking other antidepressants, they will be asked to discontinue the antidepressant for 2-4 weeks in order to participate in the study.
* Patients on other antidepressants are allowed to participate only if the antidepressant is prescribed at subtherapeutic doses for a primary indication other than mood disorders. Participants will be made aware in the consent form that the combination of the two antidepressants would be considered investigational and that the safety/efficacy profiles are unknown.
* Current alcohol or substance use disorder.
* Inability to provide consent.
* Current alcohol and/or substance use disorder as confirmed by the M.I.N.I 7.0.2.
* Presence of comorbid psychiatric disorder that is a primary focus of clinical concern as confirmed by the M.I.N.I. 7.0.2.
* Medications approved and/or employed off-label for cognitive dysfunction (e.g., psychostimulants).
* Any medication for a general medical disorder that, in the opinion of the investigator, may affect cognitive function.
* Use of benzodiazepines within 12 hours of cognitive assessments.
* Consumption of alcohol within 8 hours of cognitive assessments.
* Physical, cognitive, or language impairments sufficient to adversely affect data derived from cognitive assessments.
* Diagnosed reading disability or dyslexia.
* Clinically significant learning disorder by history.
* Electroconvulsive therapy (ECT) in the last 6 months.
* History of moderate or severe head trauma (e.g., loss of consciousness for \>1 hour), other neurological disorders, or unstable systemic medical diseases that in the opinion of the investigator are likely to affect the central nervous system.
* Pregnant and/or breastfeeding.
* Received investigational agents as part of a separate study within 30 days of the screening visit.
* Actively suicidal/presence of suicidal ideation or evaluated as being at suicide risk (as per clinical judgment).
* Currently receiving treatment with Monoamine Oxidase Inhibitors (MAOIs) antidepressants, antibiotics such as linezolid, or intravenous methylene blue.
* Previous hypersensitivity reaction to vortioxetine or any components of the formulation. Angioedema has been reported in patients treated with vortioxetine.
* Serotonin syndrome.
* Abnormal bleeding.
* Previous history of mania/hypomania.
* Angle closure glaucoma.
* Hyponatremia.
* Moderate hepatic impairment.
* Active seizure disorder/epilepsy, not controlled by medication
* Presence of any unstable medical conditions.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Brain and Cognition Discovery Foundation
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Roger S. McIntyre, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Brain and Cognition Discovery Foundation
Locations
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Brain and Cognition Discovery Foundation (BCDF)
Toronto, Ontario, Canada
Site Status
Countries
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Canada
References
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Mahase E. Covid-19: What do we know about "long covid"? BMJ. 2020 Jul 14;370:m2815. doi: 10.1136/bmj.m2815. No abstract available.
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Burke MJ, Del Rio C. Long COVID has exposed medicine's blind-spot. Lancet Infect Dis. 2021 Aug;21(8):1062-1064. doi: 10.1016/S1473-3099(21)00333-9. Epub 2021 Jun 18. No abstract available.
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Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
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Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
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Mahase E. Long covid could be four different syndromes, review suggests. BMJ. 2020 Oct 14;371:m3981. doi: 10.1136/bmj.m3981. No abstract available.
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Puntmann VO, Carerj ML, Wieters I, Fahim M, Arendt C, Hoffmann J, Shchendrygina A, Escher F, Vasa-Nicotera M, Zeiher AM, Vehreschild M, Nagel E. Outcomes of Cardiovascular Magnetic Resonance Imaging in Patients Recently Recovered From Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Nov 1;5(11):1265-1273. doi: 10.1001/jamacardio.2020.3557.
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Lenze EJ, Mattar C, Zorumski CF, Stevens A, Schweiger J, Nicol GE, Miller JP, Yang L, Yingling M, Avidan MS, Reiersen AM. Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial. JAMA. 2020 Dec 8;324(22):2292-2300. doi: 10.1001/jama.2020.22760.
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BACKGROUND
Hoertel N, Sanchez-Rico M, Vernet R, Beeker N, Jannot AS, Neuraz A, Salamanca E, Paris N, Daniel C, Gramfort A, Lemaitre G, Bernaux M, Bellamine A, Lemogne C, Airagnes G, Burgun A, Limosin F; AP-HP / Universities / INSERM COVID-19 Research Collaboration and AP-HP COVID CDR Initiative. Association between antidepressant use and reduced risk of intubation or death in hospitalized patients with COVID-19: results from an observational study. Mol Psychiatry. 2021 Sep;26(9):5199-5212. doi: 10.1038/s41380-021-01021-4. Epub 2021 Feb 4.
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BACKGROUND
Christensen MC, Loft H, McIntyre RS. Vortioxetine improves symptomatic and functional outcomes in major depressive disorder: A novel dual outcome measure in depressive disorders. J Affect Disord. 2018 Feb;227:787-794. doi: 10.1016/j.jad.2017.11.081. Epub 2017 Nov 16.
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BACKGROUND
McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.
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BACKGROUND
McIntyre RS, Harrison J, Loft H, Jacobson W, Olsen CK. The Effects of Vortioxetine on Cognitive Function in Patients with Major Depressive Disorder: A Meta-Analysis of Three Randomized Controlled Trials. Int J Neuropsychopharmacol. 2016 Jun 15;19(10):pyw055. doi: 10.1093/ijnp/pyw055.
Reference Type
BACKGROUND
Cao B, Park C, Subramaniapillai M, Lee Y, Iacobucci M, Mansur RB, Zuckerman H, Phan L, McIntyre RS. The Efficacy of Vortioxetine on Anhedonia in Patients With Major Depressive Disorder. Front Psychiatry. 2019 Jan 31;10:17. doi: 10.3389/fpsyt.2019.00017. eCollection 2019.
Reference Type
BACKGROUND
Subramaniapillai M, Mansur RB, Zuckerman H, Park C, Lee Y, Iacobucci M, Cao B, Ho R, Lin K, Phan L, McIntyre RS. Association between cognitive function and performance on effort based decision making in patients with major depressive disorder treated with Vortioxetine. Compr Psychiatry. 2019 Oct;94:152113. doi: 10.1016/j.comppsych.2019.07.006. Epub 2019 Jul 24.
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BACKGROUND
Fagiolini A, Florea I, Loft H, Christensen MC. Effectiveness of Vortioxetine on Emotional Blunting in Patients with Major Depressive Disorder with inadequate response to SSRI/SNRI treatment. J Affect Disord. 2021 Mar 15;283:472-479. doi: 10.1016/j.jad.2020.11.106. Epub 2020 Nov 19.
Reference Type
BACKGROUND
Cao B, Park C, Rosenblat JD, Chen Y, Iacobucci M, Subramaniapillai M, Mansur RB, Zuckerman H, Lee Y, McIntyre RS. Changes in sleep predict changes in depressive symptoms in depressed subjects receiving vortioxetine: An open-label clinical trial. J Psychopharmacol. 2019 Nov;33(11):1388-1394. doi: 10.1177/0269881119874485. Epub 2019 Sep 18.
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BACKGROUND
Talmon M, Rossi S, Pastore A, Cattaneo CI, Brunelleschi S, Fresu LG. Vortioxetine exerts anti-inflammatory and immunomodulatory effects on human monocytes/macrophages. Br J Pharmacol. 2018 Jan;175(1):113-124. doi: 10.1111/bph.14074. Epub 2017 Nov 28.
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Tomaz VS, Chaves Filho AJM, Cordeiro RC, Juca PM, Soares MVR, Barroso PN, Cristino LMF, Jiang W, Teixeira AL, de Lucena DF, Macedo DS. Antidepressants of different classes cause distinct behavioral and brain pro- and anti-inflammatory changes in mice submitted to an inflammatory model of depression. J Affect Disord. 2020 May 1;268:188-200. doi: 10.1016/j.jad.2020.03.022. Epub 2020 Mar 6.
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BACKGROUND
Mahableshwarkar AR, Zajecka J, Jacobson W, Chen Y, Keefe RS. A Randomized, Placebo-Controlled, Active-Reference, Double-Blind, Flexible-Dose Study of the Efficacy of Vortioxetine on Cognitive Function in Major Depressive Disorder. Neuropsychopharmacology. 2015 Jul;40(8):2025-37. doi: 10.1038/npp.2015.52. Epub 2015 Feb 17.
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BACKGROUND
Ceban F, Ling S, Lui LMW, Lee Y, Gill H, Teopiz KM, Rodrigues NB, Subramaniapillai M, Di Vincenzo JD, Cao B, Lin K, Mansur RB, Ho RC, Rosenblat JD, Miskowiak KW, Vinberg M, Maletic V, McIntyre RS. Fatigue and cognitive impairment in Post-COVID-19 Syndrome: A systematic review and meta-analysis. Brain Behav Immun. 2022 Mar;101:93-135. doi: 10.1016/j.bbi.2021.12.020. Epub 2021 Dec 29.
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Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.
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Davis HE, Assaf GS, McCorkell L, Wei H, Low RJ, Re'em Y, Redfield S, Austin JP, Akrami A. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine. 2021 Aug;38:101019. doi: 10.1016/j.eclinm.2021.101019. Epub 2021 Jul 15.
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Liao S, Teopiz KM, Kwan ATH, Le GH, Wong S, Ballum H, Rhee TG, Badulescu S, Cao B, Guo Z, Meshkat S, Phan L, Subramaniapillai M, Ho R, McIntyre RS. Relationship between anhedonia and psychosocial functioning in post-COVID-19 condition: a post-hoc analysis. Curr Med Res Opin. 2024 Aug;40(8):1407-1411. doi: 10.1080/03007995.2024.2374510. Epub 2024 Jul 8.
Reference Type
DERIVED
Teopiz KM, Kwan ATH, Le GH, Guo Z, Badulescu S, Ceban F, Meshkat S, Di Vincenzo JD, d'Andrea G, Cao B, Ho R, Rhee TG, Dev DA, Phan L, Subramaniapillai M, Mansur RB, Rosenblat JD, McIntyre RS. Association between fatigue and depressive symptoms in persons with post-COVID-19 condition: a post hoc analysis. Curr Med Res Opin. 2024 Jul;40(7):1203-1209. doi: 10.1080/03007995.2024.2360647. Epub 2024 Jun 11.
Reference Type
DERIVED
Kwan ATH, Guo Z, Ceban F, Le GH, Wong S, Teopiz KM, Rhee TG, Ho R, Di Vincenzo JD, Badulescu S, Meshkat S, Cao B, Rosenblat JD, d'Andrea G, Dev DA, Phan L, Subramaniapillai M, McIntyre RS. Assessing the Effects of Metabolic Disruption, Body Mass Index and Inflammation on Depressive Symptoms in Post-COVID-19 Condition: A Randomized Controlled Trial on Vortioxetine. Adv Ther. 2024 May;41(5):1983-1994. doi: 10.1007/s12325-024-02826-9. Epub 2024 Mar 23.
Reference Type
DERIVED
Kwan ATH, Le GH, Guo Z, Ceban F, Teopiz KM, Rhee TG, Ho R, Di Vincenzo JD, Badulescu S, Meshkat S, Cao B, Rosenblat JD, Dev DA, Phan L, Subramaniapillai M, McIntyre RS. Impacts of metabolic disruption, body mass index and inflammation on cognitive function in post-COVID-19 condition: a randomized controlled trial on vortioxetine. Ann Gen Psychiatry. 2024 Feb 29;23(1):10. doi: 10.1186/s12991-024-00494-1.
Reference Type
DERIVED
Le GH, Kwan ATH, Wong S, Guo Z, Teopiz KM, Badulescu S, Meshkat S, d'Andrea G, Ho R, Rhee TG, Cao B, Phan L, Rosenblat JD, Mansur RB, Subramaniapillai M, McIntyre RS. Impact of Elevated Body Mass Index (BMI) on Hedonic Tone in Persons with Post-COVID-19 Condition: A Secondary Analysis. Adv Ther. 2024 Feb;41(2):686-695. doi: 10.1007/s12325-023-02760-2. Epub 2023 Dec 19.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
https://covid19.who.int
World Health Organization (WHO) COVID-19 Dashboard
https://www.bsrm.org.uk/downloads/covid-19bsrmissue1-published-27-4-2020.pdf
Rehabilitation in the wake of Covid-19 - A phoenix from the ashes; British Society of Rehabilitation Medicine (BSRM)
https://patientresearchcovid19.com/research/report-1/
An Analysis of the Prolonged COVID-19 Symptoms Survey by Patient-Led Research Team
https://clinicaltrials.gov/ct2/show/NCT03835715
Study With Vortioxetine on Emotional Functioning in Patients With Depression (COMPLETE)
Other Identifiers
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BCDF002
Identifier Type: -
Identifier Source: org_study_id
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Real-life Effectiveness of Vortioxetine in Depression
NCT03555136
COMPLETED
Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
NCT00735709
COMPLETED
PHASE3
Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes
NCT00596817
COMPLETED
PHASE3
Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder
NCT00672620
COMPLETED
PHASE3
Safety and Efficacy Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
NCT01179516
COMPLETED
PHASE3
Vortioxetine as a Novel Anti-depressant With Improvement in Cognitive Abilities
NCT05104918
UNKNOWN
PHASE3
Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study
NCT01152996
COMPLETED
PHASE3
Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls
NCT01607125
COMPLETED
PHASE1
Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
NCT01355081
COMPLETED
PHASE3
Cognitive Dysfunction in MDD Patients
NCT03187093
UNKNOWN
PHASE4
Efficacy of Lu AA21004 on Cognitive Dysfunction in Major Depressive Disorder
NCT01564862
COMPLETED
PHASE2
Efficacy and Safety of Vortioxetine (Lu AA21004) in Treating Adults With Major Depressive Disorder
NCT00672958
COMPLETED
PHASE3
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-059)
NCT00035009
COMPLETED
PHASE3
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-061)
NCT00035295
COMPLETED
PHASE3
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
NCT02871297
TERMINATED
PHASE3
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-060)(COMPLETED)
NCT00035282
COMPLETED
PHASE3