Berlin Magnetic Seizure Therapy Depression Trial 01

NCT00914680 | Completed Phase 3

• 1 other identifier: BEMAST1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unipolar Depression; Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement (HAMD)

  before, after treatment

Secondary Outcomes (1)

• Neurocognitive performance

  before/after treatment

Study Arms (1)

MST

EXPERIMENTAL

Procedure: magnetic seizure therapy

Interventions

magnetic seizure therapy PROCEDURE

antidepressant treatment with MST

MST

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Psychiatry, CC15, CBF, Eschenallee 3

Berlin, 14050, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder; Bipolar Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 5, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2013
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

DE (1)