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Completed

NCT Number: NCT00914680

Berlin Magnetic Seizure Therapy Depression Trial 01

This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive episode. The investigators will perform add-on tests to assess clinical and cognitive response to treatment. It is hypothesized that MST will have an antidepressant efficacy with a beneficial neurocognitive adverse effect profile.

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Key information

Conditions

Unipolar Depression Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Mental Disorders Mood Disorders

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Psychiatry, CC15, CBF, Eschenallee 3

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is diagnosed with a severe major depressive episode
  • Patient is in a chronic current MDE and/or has had a history of recurrent MDEs
  • Patient has not had an acceptable clinical response due to failure with at least 2 antidepressant treatments during the current episode
  • Patient has a score > 20 on the HAMD24
  • Patient is stable on current psychotropic medication for at least 4 weeks
  • Patient is > 25 and < 80 years

Exclusion criteria

  • Atypical Depression or psychotic depression (according to DSM IV)
  • Other relevant psychiatric axis I or axis II diseases
  • Relevant neurological diseases
  • Relevant cardiac or pulmonary diseases with enhances anesthesiological risk (ASA Score > 3)
  • Patient is currently enrolled in another investigational study not associated with the current study
  • Patient has a history of, or evidence of, significant brain malformation or significant head injury

Treatment and study plan

magnetic seizure therapy

Procedure

antidepressant treatment with MST

Primary outcomes

  1. Clinical Improvement (HAMD)

    Time frame: before, after treatment

Secondary outcomes

  1. Neurocognitive performance

    Time frame: before/after treatment

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Investigation of Efficacy and Tolerability of Magnetic Seizure Therapy in the Treatment of Depression

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jun 5, 2009
Registry last updated
Jul 13, 2018

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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