Major Depressive Disorder Clinical Trial
— TTTOfficial title:
TBS Treatment for Treatment-Resistant Depression: a Randomized, Sham-Controlled Trial
Verified date | April 2024 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Depression is a highly disabling disease that is prevalent throughout the world. The treatments proposed and studied to date have shown to be partially effective in treating this condition. Neuromodulation strategies have been used as an alternative, especially for refractory and challenging cases. In this context, studies investigating the effectiveness of transcranial magnetic stimulation, including the theta burst stimulation (TBS) modality, have been increasing in number. However, there is still a lack of information seeking to explore the maximum effectiveness in the TBS modality. Therefore, the investigators developed a new stimulation protocol consisting of 3 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. The protocol will be performed for 15 days, totalizing 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3) and will be performed in a Magventure MagPro R30 device. The investigators will select 100 patients with unipolar major depression, following previously established inclusion and exclusion criteria, and will apply the protocol randomly, dividing the patients into an active and placebo group. The research team hypothesized that the active group patients will have greater improvement in symptoms of depression assessed by the 17-item hamilton depression scale over patients of the placebo group. In addition, other scales will be used for secondary outcomes. The researchers also hypothesized that there will be no difference between patients placed in the active or placebo groups in terms of side effects.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 59 Years |
Eligibility | Inclusion Criteria: - Inclusion criteria are: patients with a diagnosis of unipolar major depression confirmed by the MINI interview, between 18 and 59 years of age, with a Hamilton score equal to or greater than 17. In addition, patients must have undergone at least 1 first-line treatment for depression and a maximum of 3 previous unsuccessful treatments. Exclusion Criteria: - Exclusion criteria are: other mental disorders (bipolar affective disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, personality disorders, substance use disorder, psychotic disorders), history of suicide attempts or severe suicidal ideation in the last 6 months. In addition, patients who have a history of epilepsy, decompensated medical conditions, metallic implants in the skull or previous experience with transcranial magnetic stimulation will be excluded. |
Country | Name | City | State |
---|---|---|---|
Brazil | Institute of Psychiatry - University of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Depression Rating Scale (17 Items) | Scale to assess depressive symptoms - The minimum scale score is 0 and the maximum scale score is 50 points. The standardized scores are: 7 to 17 points - mild depression; 18 to 25 points - moderate depression and 26 or more points - severe depression. Higher scores mean worse clinical condition or outcome. | 5 weeks | |
Secondary | Montgomery-Asberg Depression Rating Scale | Scale to assess depressive symptoms The minimum scale score is 0 and the maximum scale score is 60 points. The standardized scores are: 7 to 19 points - mild depression; 20 to 34 points - moderate depression and 35 or more points - severe depression. Higher scores mean worse clinical condition or outcome. | 5 weeks | |
Secondary | Collateral Effects Rating Scale | Scale to assess side effects of the procedure - not a numeric scale. It consist of a scale to assess the severity of side effects between: absent, mild, moderate and severe. In addition, the investigators seek to correlate the possible side effect with the procedure in the face of the following alternatives: remotely related, possibly related, probably related, certainly related. For this, the patient's own report, will be taken into account. | 5 weeks |
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