NCT00149071

Brief Summary

A doubleblind randomised trial with active versus sham rTMS in combination with escitalopram in patients with prior treatment resistant depression in an acute 12 weeks trial with subsequent 24 weeks study phase with active versus placebo citalopram

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2004

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

November 5, 2007

Status Verified

November 1, 2007

First QC Date

September 6, 2005

Last Update Submit

November 2, 2007

Conditions

Major Depression

Keywords

Transcranial magnetic stimulation (TMS)Major depressiontreatment resistant major depression

Outcome Measures

Primary Outcomes (1)

  • depression scores

    6 weeks

Study Arms (2)

A

ACTIVE COMPARATOR

rTMS

Device: rTMSDevice: TMS

B

SHAM COMPARATOR

sham rTMS

Device: TMSDevice: rTMS

Interventions

rTMSDEVICE

15 treatments of rTMS active with a duration of 30 minutes each

A
TMSDEVICE

Transcraniel Magnetic Stimulation active and sham

AB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major depression Hamilton score above 18
  • Age 18 to 75

You may not qualify if:

  • Pregnancy og breastfeeding
  • Mental retardation and organic brain disease
  • Alcohol and substance abuse
  • Metal implants in brain, pacemakers and other electronic implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric research unit, Hilleroed Hospital,

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Line G Bretlau, MD

    Psychiatric research Unit, Hilleroed Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

March 1, 2004

Study Completion

January 1, 2006

Last Updated

November 5, 2007

Record last verified: 2007-11

Locations

DK(1)