Berlin Magnetic Seizure Therapy Depression Trial 01

NCT ID: NCT00914680

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2013-05-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MST

Group Type: EXPERIMENTAL

magnetic seizure therapy

Intervention Type: PROCEDURE

antidepressant treatment with MST

Interventions

magnetic seizure therapy

antidepressant treatment with MST

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Malek Bajbouj

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Psychiatry, CC15, CBF, Eschenallee 3

Berlin, , Germany

Countries

Germany

Other Identifiers

BEMAST1

Identifier Type: -

Identifier Source: org_study_id