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Completed

NCT Number: NCT01153139

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

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.

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)

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)

Primary outcomes

  1. Number of responders (response = decrease of the Montgomery-Åsberg Depression Rating Scale for at least 50%)

    Time frame: after the end of treatment (week 6)

Secondary outcomes

  1. Change of the Hamilton rating scale for depression (HAMD 17)

    Time frame: baseline, after the end of treatment (week 6)

  2. Change of the Beck Depression Inventory (BDI)

    Time frame: baseline, after the end of treatment (week 6)

  3. Change of the Montgomery-Asberg rating scale for depression (MADRS) score

    Time frame: baseline, after the end of treatment (week 6)

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: TheBuS_D

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jun 29, 2010
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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