Theta Burst Study Ghent

Study Overview
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Brief Summary
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50 Right-handed antidepressant-free unipolar depressed patients (age 18-65 years) will be treated with in total 20 Theta burst sessions; these will be spread over 4 days. On each stimulation day, a given patient shall receive 5 sessions with a between session delay of 10 to 15 minutes. Patients will be selected using the structured Mini-International Neuropsychiatric Interview (MINI). All will be at least stage I treatment resistant. Because concomitant antidepressant treatment can confound outcome results, all patients will go through a medication washout before entering the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the treatment protocol. Only habitual benzodiazepine agents will be allowed. All patients will be closely matched for gender and age with 50 never-depressed medication-free healthy volunteers. Only baseline measurements will be collected: no volunteer will undergo the treatment. We expect that real Theta burst treatment and not sham will result in a significant and clinical meaningful response.

Official Title
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The Effects of Thetaburst Stimulation in Treatment Resistant Unipolar Depressed Patients

Conditions
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Unipolar Major Depression

Intervention / Treatment
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* Other: Theta burst stimulation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: antidepressant-free unipolar depression age between 18 and 65 years right handed at least stage I treatment resistant Exclusion Criteria: current or past history of epilepsy, neurosurgical interventions, having a pacemaker or metal or magnetic objects in the brain, alcohol dependence and suicide attempts within 6 months before the start of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theta burst stimulation<br>Specific developed sham coil. | Other: Theta burst stimulation.<br>* In each session, subjects will receive 54 Theta burst trains of 2 seconds duration, separated by an intertrain interval of 18 seconds, delivered on the left dorsolateral prefrontal cortex (DLPFC). The treatment protocol of in total 20 Theta burst sessions will be spread over 4 days, yielding a total of 32400 stimuli. On each stimulation day, a given patient shall receive 5 sessions with a between session delay of 10 to 15 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression severity in Theta burst treatment at baseline. | Depression severity will be assessed, using the 21-item Beck Depression Inventory (BDI-II) and the 17-item Hamilton Depression Rating Scale (HDRS). | At baseline. | 
| Depression severity of Theta burst treatment after 1 week of treatment. | Depression severity will be assessed, using the 21-item Beck Depression Inventory (BDI-II) and the 17-item Hamilton Depression Rating Scale (HDRS). | After 1 week of TBS-rTMS/sham treatment. | 
| Depression severity will be assessed at the end of the final second week of the stimulation protocol. | Depression severity will be assessed, using the 21-item Beck Depression Inventory (BDI-II) and the 17-item Hamilton Depression Rating Scale (HDRS). | At the end of the final second week of the stimulation protocol. | 
| Depression severity will be assessed two weeks after stimulation. | Depression severity will be assessed, using the 21-item Beck Depression Inventory (BDI-II) and the 17-item Hamilton Depression Rating Scale (HDRS). | Two weeks after stimulation. | 
| Suicidal ideation will be assessed at baseline. | Suicidal ideation will be assessed with the suicidal ideation scale (SSI). | At baseline. | 
| Suicidal ideation will be assessed after 1 week of treatment. | Suicidal ideation will be assessed using the suicidal ideation scale (SSI). | After 1 week of TBS-rTMS/sham treatment. | 
| Suicidal ideation will be assessed at the end of the final second week of the stimulation protocol. | Suicidal ideation will be assessed using the suicidal ideation scale (SSI). | At the end of the final second week of the stimulation protocol. | 
| Suicidal ideation will be assessed two weeks after stimulation. | Suicidal ideation will be assessed using the suicidal ideation scale (SSI). | Two weeks after stimulation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting state functional connectivity; diffusion MRI at baseline. | Siemens 3T MRI. | At baseline. | 
| Resting state functional connectivity; diffusion MRI after 1 week of treatment. | Siemens 3T MRI. | After 1 week of TBS-rTMS/sham treatment. | 
| Resting state functional connectivity; diffusion MRI at the end of the final second week of the stimulation protocol. | Siemens 3T MRI. | At the end of the final second week of the stimulation protocol. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression