Intermittent Theta Burst Stimulation for MDD
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
Summary
- Conditions
- Major Depressive Disorder
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 65 years
- Gender
- Both males and females
Description
The purpose of this research study is to evaluate the effectiveness and efficacy of intermittent Theta Burst Stimulation (iTBS) for treatment of Major Depressive Disorder (MDD). Subjects will be randomly assigned to two weeks (10 sessions) of treatment with open-label iTBS, blinded iTBS or blinded s...
The purpose of this research study is to evaluate the effectiveness and efficacy of intermittent Theta Burst Stimulation (iTBS) for treatment of Major Depressive Disorder (MDD). Subjects will be randomly assigned to two weeks (10 sessions) of treatment with open-label iTBS, blinded iTBS or blinded sham. 'Open-label' means that you (the subject) and the study staff will know that you are receiving active iTBS treatment. 'Blinded' or 'sham-controlled' means that you, the subject, will not know whether the treatment you receive is the active treatment or the non-active treatment. In the 'sham' condition, the stimulator will turn on but will not actually be stimulating your brain. Subjects who do not show remission of symptoms after the first 2 weeks of treatment will receive 10 additional treatment sessions with open-label active iTBS. Subjects will be evaluated at Week 12 to assess the durability of symptoms changes.
Tracking Information
- NCT #
- NCT02506127
- Collaborators
- Not Provided
- Investigators
- Not Provided
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