- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01468610
Neurocognition and Work Productivity in Major Depressive Disorder (MDD)
8. april 2015 opdateret af: University of British Columbia
Neurocognition and Work Productivity in Major Depressive Disorder
This study will investigate the relationships between subjective cognitive complaints, neurocognitive deficits, and work productivity in participants with Major Depressive Disorder (MDD), before and after 8 weeks of treatment with an antidepressant medication.
Our hypothesis is that, in working participants with MDD of at least moderate severity, neurocognitive deficits will predict poorer work functioning and productivity.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
47
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V6T 2A1
- University of British Columbia, Department of Psychiatry
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of Major Depressive Disorder as per DSM-IV-TR
- Current employment of at least 15 hours per week
- Baseline score of 23 or greater on the Montgomery-Asberg Depression Rating Scale, indicating at least moderately severe depression
- Baseline score of 6 or greater on the British Columbia Cognitive Complaints Inventory, indicating at least moderate subjective cognitive complaints
- Competency to give informed consent
Exclusion Criteria:
- Current receipt of short-term or long-term disability benefits from employer
- Serious suicidal risks as judged by the investigators
Other DSM-IV-TR diagnoses:
- organic mental disorders
- active substance abuse/dependence, including alcohol
- schizophrenia, paranoid or delusional disorders, or other psychotic disorders
- (as primary diagnosis:) panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder
- bipolar disorder
- bulimia nervosa or anorexia nervosa
- Serious illness that is not stabilized, including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease
- Regular/current use of other psychotropic drugs and/or herbaceuticals
- Use of fluoxetine within 5 weeks of Visit 1, monoamine oxidase inhibitors within 14 days of Visit 1, and other antidepressants within 7 days of Visit 1 (all to ensure adequate drug washouts prior to neurocognitive assessment)
- Previous treatment with desvenlafaxine
- Treatment-resistance in the current episode, as defined by failure (i.e., lack of clinically significant response) of 2 or more antidepressants given at therapeutic doses for at least 6 weeks
- Any history of treatment with electroconvulsive therapy
- Initiation of formal psychotherapy (e.g., cognitive-behavioural therapy or interpersonal psychotherapy) with 2 months of Visit 1, or plans to start such psychotherapy during this study
- Current use of any other form of treatment for depression
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Workers with MDD
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50-100 mg daily for 8 weeks
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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cognitive functioning as determined by neuropsychological testing
Tidsramme: change from baseline to 8 weeks
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Neuropsychological testing in 5 domains (memory, psychomotor speed, reaction time, cognitive flexibility, and complex attention) is conducted using computerized measures, both at baseline and after 8 weeks of standard medical care involving antidepressant medication (flexibly-dosed desvenlafaxine)
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change from baseline to 8 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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work productivity as determined by rating scales
Tidsramme: change from baseline to 8 weeks
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Work functioning (attendance and productivity) is assessed using subjective and objective measures, both at baseline and after 8 weeks of standard medical care involving antidepressant medication (flexibly-dosed desvenlafaxine)
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change from baseline to 8 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Raymond W Lam, MD, FRCPC, University of British Columbia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Alonso-Prieto E, Rubino C, Lucey M, Evans VC, Tam EM, Woo C, Iverson GL, Chakrabarty T, Yatham LN, Lam RW. Relationship between work functioning and self-reported cognitive complaints in patients with major depressive disorder treated with desvenlafaxine. Psychiatry Res. 2019 Feb;272:144-148. doi: 10.1016/j.psychres.2018.12.062. Epub 2018 Dec 10.
- Sarfati D, Evans VC, Tam EM, Woo C, Iverson GL, Yatham LN, Lam RW. The impact of fatigue and energy on work functioning and impairment in patients with major depressive disorder treated with desvenlafaxine. Int Clin Psychopharmacol. 2017 Nov;32(6):343-349. doi: 10.1097/YIC.0000000000000192.
- Lam RW, Iverson GL, Evans VC, Yatham LN, Stewart K, Tam EM, Axler A, Woo C. The effects of desvenlafaxine on neurocognitive and work functioning in employed outpatients with major depressive disorder. J Affect Disord. 2016 Oct;203:55-61. doi: 10.1016/j.jad.2016.05.074. Epub 2016 May 31.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2012
Primær færdiggørelse (Faktiske)
1. september 2014
Studieafslutning (Faktiske)
1. december 2014
Datoer for studieregistrering
Først indsendt
7. november 2011
Først indsendt, der opfyldte QC-kriterier
8. november 2011
Først opslået (Skøn)
9. november 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Adfærdsmæssige symptomer
- Psykiske lidelser
- Stemningsforstyrrelser
- Depression
- Depressiv lidelse
- Depressiv lidelse, major
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Psykotropiske stoffer
- Neurotransmitter optagelseshæmmere
- Membrantransportmodulatorer
- Antidepressive midler
- Serotonin- og Noradrenalin-genoptagelseshæmmere
- Desvenlafaxinsuccinat
Andre undersøgelses-id-numre
- H11-02646
- WS2087153 (Andet bevillings-/finansieringsnummer: Pfizer Canada Inc.)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Større depressiv lidelse
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Rotman Research Institute at BaycrestRekrutteringMajor Depressive Disorder (MDD)Canada
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ACADIA Pharmaceuticals Inc.RekrutteringDepressiv lidelse, behandlingsresistent | Major Depressive Disorder (MDD)Forenede Stater
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University of PretoriaIkke rekrutterer endnuMajor Depressive Disorder (MDD)Saudi Arabien
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Tel Aviv UniversityIkke rekrutterer endnuMajor Depressive Disorder (MDD)Israel
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Instituto Mexicano del Seguro SocialAfsluttet
-
Yonggui YuanIkke rekrutterer endnuMajor Depressive Disorder (MDD)Kina
-
Daniel LindqvistLund University; KetabonRekrutteringMajor Depressive Disorder (MDD)Sverige
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King's College LondonCardiff and Vale University Health Board; South London and Maudsley NHS... og andre samarbejdspartnereRekrutteringMajor Depressive Disorder (MDD)Det Forenede Kongerige
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Supernus Pharmaceuticals, Inc.RekrutteringMajor Depressive Disorder (MDD)Forenede Stater
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University of PennsylvaniaRekruttering
Kliniske forsøg med desvenlafaxine
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Seoul National University HospitalPfizer; Seoul National University Bundang Hospital; Korea Cancer Center HospitalAfsluttetBrystneoplasmer | Hot blinkerKorea, Republikken
-
Wyeth is now a wholly owned subsidiary of PfizerPfizerAfsluttetStørre depressiv lidelseForenede Stater
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Mochida Pharmaceutical Company, Ltd.PfizerAfsluttet
-
Tongji HospitalAktiv, ikke rekrutterende
-
Tongji HospitalAktiv, ikke rekrutterendeSpændingstype HovedpineKina
-
Corporacion Parc TauliPfizerUkendt
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PfizerAfsluttetStørre depressiv lidelseKorea, Republikken
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START Clinic for Mood and Anxiety DisordersAfsluttetGeneraliseret angstlidelseCanada
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Luye Pharma Group Ltd.Afsluttet
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Centre for Addiction and Mental HealthAfsluttet