- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00220610
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION
Right Parietal Inhibition With rTMS in the Treatment of Depression
Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.During the rTMS session, the coil was centered flat over the right parietal cortex.
We follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure the depression with different rating scales.
We hypothesized that rTMS has a positive effect in the treatment of depression
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Judith van der Riet, Drs.
- Telefonnummer: 0031-20-5108562
- E-mail: j.vanderriet@slaz.nl
Studiesteder
-
-
-
Amsterdam, Holland, 1061 AE
- Rekruttering
- st. Lucas Andreas Ziekenhuis/ Hospital
-
Kontakt:
- Judith van der Riet, Drs
- Telefonnummer: 0031-20-5108562
- E-mail: j.vanderriet@slaz.nl
-
Kontakt:
- G.F Koerselman, Prof.dr.
- Telefonnummer: 0031-20-5108562
- E-mail: f.koerselman@slaz.nl
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- In and outpatients aged between 16 and 65 who met DSM-IV criteria for major depressive episode, and who had a score of 25 or higher on the 10-item Montgomery Asberg Depression Rating Scale (MADRS) were included
Exclusion Criteria:
- A history of epilepsy and any other medical disorder that should preclude the administration of rTMS. Only SSRI's, Mirtazapine and Promethazine as psychotropic medication was accepted if the dosage of antidepressive medication had not been changed for 6 weeks, and if the dosage of Promethazine had not been changed for 2 weeks prior to inclusion. Antidepressive medication had to remain stable during the 14 weeks of the study.
Furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
To determine the depression (and so the effect of the treatment)we use the 10-item Montgomery Asberg Depression Rating Scale (MADRS)and we measure before tms (T=0), at week 1 (T=1), at week 2 (T=2), at week 4 (T=3), at week 8 (T=4), at week 14 (T=5)
|
Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale)
|
Sekundære resultatmål
Resultatmål |
---|
-Changes in anxiety
|
-.Autonomic changes
|
-.changes in the emotioneal attention, in the emotional memory en in de emotional recognition.
|
-.Biochemical changes
|
-.Changes in the EEG
|
>> measured before tms and after (at T=0 and T=2)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: G.F Koerselman, prof. dr., st Lucas Andreas Ziekenhuis
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CCMO03.3741/SH/P03.1231L
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 Depression
-
ProgenaBiomeRekrutteringDepression | Depression, postpartum | Depression, angst | Depression Moderat | Depression Alvorlig | Klinisk depression | Depression i remission | Depression, Endogen | Depression KroniskForenede Stater
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRekrutteringDepression | Depression Moderat | Depression Alvorlig | Depression MildForenede Stater
-
University of California, San FranciscoRekrutteringDepression Moderat | Depression Mild | Depression, teenagerForenede Stater
-
Washington University School of MedicineAfsluttetBehandlingsresistent depression | Senlivsdepression | Geriatrisk depression | Refraktær depression | Terapi-resistent depressionForenede Stater, Canada
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RekrutteringDepression Moderat | Depression Alvorlig | Depression MildBelgien
-
Baylor College of MedicineUniversity of TexasRekrutteringDepression | Depression Moderat | Depression Alvorlig | Selvmord og selvskade | Depression i ungdomsårene | Depression MildForenede Stater
-
Charite University, Berlin, GermanyAfsluttetBehandlingsresistent depression | Depression, Unipolar | Depression KroniskTyskland
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoAfsluttetDepression Moderat | Depression MildForenede Stater, Dominikanske republik
-
Federal Research Center of Fundamental and Translational...AfsluttetDepression Moderat | Depression MildDen Russiske Føderation
-
Ludwig-Maximilians - University of MunichAfsluttetTerapi-resistent svær depressionTyskland
Kliniske forsøg med Transkraniel magnetisk stimulering
-
Shirley Ryan AbilityLabAfsluttetAldersrelateret hukommelsessvækkelseForenede Stater
-
Tianjin Huanhu HospitalRekrutteringParkinsons sygdom | Kognitiv svækkelseKina
-
Shalvata Mental Health CenterUkendtTvangslidelse | Tourettes syndromIsrael
-
Shalvata Mental Health CenterUkendtBorderline personlighedsforstyrrelseIsrael
-
Emory UniversityNational Institute of Mental Health (NIMH)Rekruttering
-
NeuralieveAfsluttetMigræne med AuraForenede Stater
-
Medical University of South CarolinaRekrutteringSequelae af slagtilfælde | Motivering | Apati | Slagtilfælde (CVA) eller TIA | Slagtilfælde/hjerneangreb | AbuliaForenede Stater
-
University of ManitobaRekruttering
-
University of PennsylvaniaAfsluttetAttention Deficit Disorder med hyperaktivitet (ADHD)Forenede Stater
-
Centre hospitalier de Ville-Evrard, FranceRekruttering