The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy
19. april 2018 opdateret af: Shanghai Mental Health Center
The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy: A Randomized Clinical Trial And Its Standard Technology Promotion Research
- To determine the influencing factors of modified electroconvulsive therapy (MECT);
- To determine the influencing factors and reversibility of the cognitive impairment caused by MECT;
- To determine the duration of efficacy of MECT and its affecting factors.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
280
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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Shanghai, Kina
- Shanghai Mental Health Center
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Aged over 18 years (when informed consent was got), male or female
- Meet International Classification of Diseases-10(ICD-10) diagnostic criteria for depression
- Scored 18 or above on the HAM-D Scale which included 17 items
- Clinical Global Impression(CGI)-severity score ≥ 4
- Provided written informed consent
Exclusion Criteria:
- Any depressive disorders not due to major depressive disorder
- Meet other diagnosis criteria in Diagnostic and Statistical Manual of Mental Disorders-IV-Test Revision(DSM-IV-TR) Axis I
- With a history of acute or chronic renal failure, liver cirrhosis or active hepatopathy
- With clinically significant abnormal results of laboratory test, which are considered to have impact on treatment efficacy and the safety of participants
- With a history of severe or unstable physical disease including nervous system disease and myocardial infarction
- Undergoing alcoholism or alcohol (or substance) abuse during 30 days or 6 months before the trial
- With no response to previous ECT treatment
- Received transcranial magnetic stimulation treatment in the last 6 months
- Allergic to propofol, etomidate and succinylcholine chloride
- During pregnancy or lactation
- With a history of stroke in the last month
- Enrolled in any other clinical trial 30 days prior to the baseline
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Bilateral temporal and propofol
During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia.
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Eksperimentel: Bilateral temporal and etomidate
During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.
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Eksperimentel: The right temporal and propofol
During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia.
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Eksperimentel: The right temporal and etomidate
During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia.
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Eksperimentel: Bilateral frontal and propofol
During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia.
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Eksperimentel: Bilateral frontal and etomidate
During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia.
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Aktiv komparator: Standard-therapy Group
During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Change in Hamilton Depression Scale(HAMD) Scores
Tidsramme: Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
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Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
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Change in Wechsler Memory Scale (WMS) Scores as a Measure of Safety
Tidsramme: Change from Baseline in Wechsler Memory Scale (WMS) Scores at 42d and 180d after the last MECT session
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Change from Baseline in Wechsler Memory Scale (WMS) Scores at 42d and 180d after the last MECT session
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State
Tidsramme: 42d and 180d after the last MECT session
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42d and 180d after the last MECT session
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Resting-state/Task-state functional magnetic resonance imaging (fMRI)
Tidsramme: Change form Baseline in Resting-state/Task-state fMRI Imging Results at 42d and 180d after the last MECT session
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Change form Baseline in Resting-state/Task-state fMRI Imging Results at 42d and 180d after the last MECT session
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Change in Hamilton Anxiety Scale(HAMA) Scores
Tidsramme: Change from Baseline in Hamilton Anxiety Scale Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
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Change from Baseline in Hamilton Anxiety Scale Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
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Change in Clinical Global Impression-severity of illness(CGI-SI) Scores as a Measure of Efficacy
Tidsramme: Change from Baseline in CGI-SI Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
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Change from Baseline in CGI-SI Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
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Change in Wisconsin Card Sorting Test(WCST) Scores as a Measure of Safety
Tidsramme: Change from Baseline in Wisconsin Card Sorting Test(WCST) Scores at 42d and 180d after the last MECT session
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Change from Baseline in Wisconsin Card Sorting Test(WCST) Scores at 42d and 180d after the last MECT session
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Change in P300/P50 Event-Related Potentials(ERP)
Tidsramme: Change from Baseline in P300/P50 Event-Related Potentials(ERP) at 42d and 180d after after the last MECT session
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Change from Baseline in P300/P50 Event-Related Potentials(ERP) at 42d and 180d after after the last MECT session
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 2013
Primær færdiggørelse (Faktiske)
31. december 2017
Studieafslutning (Faktiske)
31. december 2017
Datoer for studieregistrering
Først indsendt
13. februar 2014
Først indsendt, der opfyldte QC-kriterier
16. februar 2014
Først opslået (Skøn)
19. februar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. april 2018
Sidst verificeret
1. december 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Adfærdsmæssige symptomer
- Psykiske lidelser
- Stemningsforstyrrelser
- Neurokognitive lidelser
- Kognitionsforstyrrelser
- Depression
- Depressiv lidelse
- Kognitiv dysfunktion
- Depressiv lidelse, major
- Lægemidlers fysiologiske virkninger
- Depressive midler til centralnervesystemet
- Bedøvelsesmidler, intravenøst
- Bedøvelsesmidler, general
- Bedøvelsesmidler
- Hypnotika og beroligende midler
- Propofol
- Etomidate
Andre undersøgelses-id-numre
- SHDC12012109
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 .
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