NCT00299403

Brief Summary

The aim of the present study is to compare the antidepressant effect of electroconvulsive therapy ( ECT) with that of low frequency repetitive transcranial magnetic stimulation of the right prefrontal cortex. In the same study we investigate the value of saliva cortisol as a predictor of treatment outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 2, 2008

Status Verified

June 1, 2008

Enrollment Period

5 years

First QC Date

March 3, 2006

Last Update Submit

June 30, 2008

Conditions

Depressive Disorder

Keywords

Depressive disorder,Antidepressant effect,rTMS,ECT,cognition,Saliva cortisolnoninferiority trial

Outcome Measures

Primary Outcomes (1)

  • The total 17-item score on the Hamilton Rating Scale for depression

    during 3 weeks of treatment and 4 week s after last treatment

Secondary Outcomes (1)

  • UKU-side effect score

    at baseline at day 10 during the treatment period, just after termination of treatment and after 4 weeks of follow-up

Study Arms (2)

1

ACTIVE COMPARATOR

Right frontal low frequency rTMS

Procedure: Right prefrontal lowfrequency ( 1 hz) rTMS.

2

ACTIVE COMPARATOR

electroconvulsive therapy (ECT). Right unilateral ECT 3 time a week in 3 weeks

Procedure: Electroconvulsive therapy (ECT)

Interventions

Right prefrontal lowfrequency ( 1 hz) rTMS.PROCEDURE

Right prefrontal low frequency (1 hz) rTMS. 15 sessions with one daily session during 3 weeks (weekends excluded). Each session covering 2 x 60 minutes of stimulation separated with an intertrain interval of 3 minutes Arms: 2

1
Electroconvulsive therapy (ECT)PROCEDURE

9 ECT ( 3 each week) during 3 weeks

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to Psychiatric Hospital in Aarhus.
  • The patient should be candidate for ECT.
  • Moderate or severely depressed/Major depressed (ICD-10/DSM-IV)
  • A total score on the Hamilton (17-item) rating scale for depression of 20 or above, or a subscale score of 10 ore above.
  • Right handed,
  • Age 18-80 years

You may not qualify if:

  • Organic brain disease
  • Epilepsy
  • Metal devices in operated into the brain or chest.
  • The patient is wearing cardiac pacemaker.
  • Medical illness associated with disturbed CNS function
  • Pregnancy
  • Serious suicidality
  • Severe agitation or delirium
  • Alcoholic or drug dependency
  • The patients exposed to coercive measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Aarhus, Risskov

Aarhus, Risskov, 8240, Denmark

Location

Related Publications (2)

  • Klein E, Kreinin I, Chistyakov A, Koren D, Mecz L, Marmur S, Ben-Shachar D, Feinsod M. Therapeutic efficacy of right prefrontal slow repetitive transcranial magnetic stimulation in major depression: a double-blind controlled study. Arch Gen Psychiatry. 1999 Apr;56(4):315-20. doi: 10.1001/archpsyc.56.4.315.

    PMID: 10197825BACKGROUND

  • Hansen PE, Ravnkilde B, Videbech P, Clemmensen K, Sturlason R, Reiner M, Parner E, Rosenberg R, Vestergaard P. Low-frequency repetitive transcranial magnetic stimulation inferior to electroconvulsive therapy in treating depression. J ECT. 2011 Mar;27(1):26-32. doi: 10.1097/YCT.0b013e3181d77645.

    PMID: 20351570DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

Transcranial Magnetic StimulationElectroconvulsive Therapy

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Poul Erik Buchholtz Hansen, senior phys.

    Aarhus University Hospital, Risskov, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 6, 2006

Study Start

May 1, 2002

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

July 2, 2008

Record last verified: 2008-06

Locations

DK(1)