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Effectiveness of Theta-burst Stimulation (TBS) in Patients With Major Depression

NCT ID: NCT01240083

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Depression is a common mental disorder that presents with depressed mood, loss of interest, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, and poor concentration. These problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities, at its worst, depression can lead to suicide.Depression can be reliably diagnosed in primary care. Antidepressant medications and brief, structured forms of psychotherapy are effective for 60-80 % of those affected and can be delivered in primary care.

In patients with depression the cerebral metabolism is deranged in some specific areas such as hypoexcitability in frontal cortical areas. High-frequency rTMS of the dorsolateral prefrontal cortex (DLPFC) has been investigated for the treatment of hypoexcitability disorders. Pilot data indicate that the mild effects of the rTMS could be increased by a special kind of TMS, the Theta-burst stimulation. 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.

Conditions

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Depression

Keywords

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Depression Transcranial magnetic stimulation Thetaburst Stimulation Alternative treatment methods

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Thetaburst Stimulation

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

Group Type EXPERIMENTAL

Thetaburst Stimulation

Intervention Type DEVICE

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)

High frequency rTMS

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

Group Type EXPERIMENTAL

High frequency rTMS

Intervention Type DEVICE

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)

Placebo Stimulation

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

Group Type EXPERIMENTAL

Placebo Stimulation

Intervention Type DEVICE

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

Interventions

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Thetaburst Stimulation

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)

Intervention Type DEVICE

High frequency rTMS

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)

Intervention Type DEVICE

Placebo Stimulation

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

Intervention Type DEVICE

Other Intervention Names

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Transcranial Magnetic Stimulation Theta-burst Transcranial Magnetic Stimulation, High frequency repetitive TMS Transcranial Magnetic Stimulation Sham Stimulation

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Regensburg

OTHER

Sponsor Role lead

Responsible Party

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Berthold Langguth, MD, Ph.D.

MD, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berthold Langguth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg- Dept. of Psychiatry

Michael Landgrebe, MD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg, Dept. of Psychiatry

Julia Burger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg- Dept. of Psychiatry

Locations

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University of Regensburg- Dept of Psychiatry

Regensburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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Uni-Reg-TB1

Identifier Type: -

Identifier Source: org_study_id