Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression

NCT ID: NCT01153139

Last Updated: 2013-07-16

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

PHASE2/PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-07-31

Brief Summary

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Repetitive transcranial magnetic stimulation has been shown to be moderately effective in the treatment of major depression. Theta burst stimulation (TBS) is a new form of rTMS that may exert larger effects.

This sham-controlled study examines the effectivity of daily bilateral TBS to the dorsolateral frontal cortex over 6 weeks in 2x16 patients with major depression add on to the local standard of a combined pharmacological/psychotherapeutical treatment.

Detailed Description

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Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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bilateral theta burst stimulation to the DLPFC

intermittent TBS (iTBS) to the left DLPFC continuous TBS (cTBS) to the right DLPFC

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)

Intervention Type DEVICE

intermittent TBS (iTBS) to the left DLPFC (600 stimuli, 80% resting motor threshold) continuous TBS (cTBS) to the right DLPFC (600 stimuli, 80% resting motor threshold)

Sham stimulation

Sham stimulation with a 45° tilted coil

Group Type PLACEBO_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)

Intervention Type DEVICE

intermittent TBS (iTBS) to the left DLPFC (600 stimuli, 80% resting motor threshold) continuous TBS (cTBS) to the right DLPFC (600 stimuli, 80% resting motor threshold)

Interventions

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Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)

intermittent TBS (iTBS) to the left DLPFC (600 stimuli, 80% resting motor threshold) continuous TBS (cTBS) to the right DLPFC (600 stimuli, 80% resting motor threshold)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* major Depression
* informed consent

Exclusion Criteria

* seizures in medical history
* metallic implants
* deep brain stimulation
* cardiac pacemaker
* brain trauma
* psychotic symptoms
* substance abuse
* pregnancy
* Benzodiazepines other than Lorazepam \>1mg/d
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Christian Plewnia, MD

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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124/2009BO1

Identifier Type: -

Identifier Source: org_study_id

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