NCT01240083

Brief Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) as well as Theta- Burst Stimulation of the frontal cortex are used to modulate the neuronal excitability in patients with depression. In the proposed study we investigate whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in patients with a depressive episode.

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 depression

Timeline
Completed

Started Apr 2010

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

April 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

1.4 years

First QC Date

November 12, 2010

Last Update Submit

October 14, 2013

Conditions

Depression

Keywords

DepressionTranscranial magnetic stimulationThetaburst StimulationAlternative treatment methods

Outcome Measures

Primary Outcomes (1)

  • Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)

    19 days

Secondary Outcomes (2)

  • Change in the Beck Depression Inventar, the Clinical Global Impression Scale, the Global Assessment of Functioning scale, the Alertness (Baseline versus end of treatment/ day 19, follow-up I/ day 47, follow-up II/ day 75)

    75 days

  • Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19, follow-up I/ day 47, follow-up II/ day 75)

    75 days

Study Arms (3)

Thetaburst Stimulation

EXPERIMENTAL

1: Thetaburst stimulation: right DLPFC continuous TBS followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 stimuli, 80% motorthreshold

Device: Thetaburst Stimulation

High frequency rTMS

EXPERIMENTAL

2: Experimental high frequency rTMS ( Alpine Biomed Mag Pro Option) : 1000 stimuli of 1 Hz over the right DLPFC, 110% motor threshold, followed by 1000 stimuli of 10 Hz over the left DLPFC , 110% motorthreshold

Device: High frequency rTMS

Placebo Stimulation

EXPERIMENTAL

3: Sham Stimulation (Sham coil): right DLPFC continuous TBS, followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 Stimuli, 80% motorthreshold

Device: Placebo Stimulation

Interventions

Thetaburst StimulationDEVICE

Thetaburst stimulation: continuous TBS over the right DLPFC, followed by intermitted TBS over the left DLPFC, each with 50 Hz, together 1200 stimuli (80% motorthreshold)

Also known as: Transcranial Magnetic Stimulation, Theta-burst
Thetaburst Stimulation
High frequency rTMSDEVICE

Experimental high frequency rTMS ( Alpine Biomed Mag Pro Option) : 1000 stimuli of 1 Hz over the right DLPFC (110% motor threshold)followed by 1000 stimuli of 10 Hz over the left DLPFC (110% motorthreshold)

Also known as: Transcranial Magnetic Stimulation,, High frequency repetitive TMS
High frequency rTMS
Placebo StimulationDEVICE

Sham Stimulation (Sham coil):right DLPFC continuous TBS, followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 Stimuli, 80% motorthreshold

Also known as: Transcranial Magnetic Stimulation, Sham Stimulation
Placebo Stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Episode of depression (unipolar or bipolar)( ICD-10)
  • Female or male between 18 and 70 years
  • Skills to participate in all study procedures
  • or more points in the Hamiliton rating scale or depression
  • Stable antidepressant drugs
  • Written informed consent

You may not qualify if:

  • Clinically relevant unstable internal or neurological comorbidity
  • Evidence of significant brain malformations or neoplasm, head injury
  • Cerebral vascular events
  • Neurodegenerative disorders affecting the brain or prior brain surgery
  • Metal objects in and around body that can not be removed
  • Pregnancy
  • Alcohol or drug abuse
  • Epilepsy or a pathological EEG
  • Heart pacemaker
  • High dose tranquillizers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regensburg- Dept of Psychiatry

Regensburg, Bavaria, 93053, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Berthold Langguth, MD

    University of Regensburg- Dept. of Psychiatry

    PRINCIPAL INVESTIGATOR

  • Michael Landgrebe, MD

    University of Regensburg, Dept. of Psychiatry

    PRINCIPAL INVESTIGATOR

  • Julia Burger, MD

    University of Regensburg- Dept. of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D.

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 15, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

DE(1)