Theta-Burst Stimulation in Major Depressive Episodes With Mixed Characteristics.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bipolar Disorder
- Depressive Disorder
- Depressive Episode
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Double-blind, randomized, parallel-group, 6-week, sham-controlled clinical trial.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: Allocation masking will be done through sequentially numbered cards that will determine which group each patient will belong to. The card determines whether the coil to be used will produce actual or simulated stimulation. A secretary who does not participate directly in the research will be responsible for handling the numbered cards to the patient prior to each session. Participants and staff will not fully know the status of allocation groups.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
INTRODUCTION: Mixed-specifier mood disorders are probably a different subgroup in terms of response to treatment, socio-demographic parameters, course and family history. The investigators will perform a clinical trial of theta-burst stimulation (TBS) in mixed depressive episodes of both bipolar (I ...
INTRODUCTION: Mixed-specifier mood disorders are probably a different subgroup in terms of response to treatment, socio-demographic parameters, course and family history. The investigators will perform a clinical trial of theta-burst stimulation (TBS) in mixed depressive episodes of both bipolar (I and II) and major depressive disorders. METHODS: The study is designed as a randomized, sham-controlled, double-blinded clinical trial evaluating TBS for the treatment of moderate or severe major depressive episodes with mixed features of patients receiving at least one first or second line pharmacological treatment for depressive episodes without adequate response. Ninety adult (18 to 65 yo) patients will be enrolled and submitted to 6-week (comprising 5 consecutive days a week sessions for the first 3 weeks and then 2 days a week for a further 3 week) of inhibitory followed by excitatory TBS in dorsolateral prefrontal cortex. Participants will be assessed using clinical and neuropsychological tests before and after the intervention. The primary outcome is change in Montgomery-Asberg Depression Scale (MADRS) score over time and across groups. Cognitive parameters will also be assessed with neuropsychological tests.
Tracking Information
- NCT #
- NCT04123301
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ricardo Moreno, PHD University of Sao Paulo
Get Well Soon