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| Name | Class |
|---|---|
| Universitair Ziekenhuis Brussel | OTHER |
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This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases.
Phase 1: Bipolar depressed patients will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews (M.I.N.I.-Plus 5.0.0, HRSD-17). The presence of exclusion criteria will be evaluated. Eligible patients will undergo MRI brain imaging for TMS neuronavigation
Phase 2: Baseline clinical, cognitive and psychomotor assessments will take place. Patients will also undergo blood samples for laboratory and research assessments.
TBS involves applying triple-pulse 50 Hz bursts given at a rate of 5 Hz uninterrupted trains (1). Patients will be treated with in total 20 continuous Theta Burst Stimulation (cTBS) session (900 pulses per session) over the right dorsolateral prefrontal cortex, which will be spread over 4 days. A stimulation intensity of 100% of the subject's resting motor threshold (rMT) of the right abductor pollicis brevis muscle will used.
Patients will be randomized to receive either the real cTBS or sham treatment. Sham stimulation will be applied with a sham coil. The sham coil produces identical sounds but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. The investigators expect that real cTBS treatment and not sham will result in a significant and clinical meaningful response.
Phase 3: Two post-treatment assessment moments will take place respectively 3 (max. 4) days and 10 (max. 11) days after the last treatment day. The assessments are the same clinical, cognitive and psychomotor assessments as in phase 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active cTBS | Active Comparator |
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| Sham cTBS | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cTBS | Device | In the cTBS arm, the patients will receive 5 daily session cTBS (5 times uninterrupted train of 900 pulses) separated by a 15 min interval. Patients will be treated with in total 20 cTBS sessions over the right dorsolateral prefrontal cortex, spread over 4 days. A stimulation intensity of 100 % of the resting motor threshold (rMT) of the right abductor pollicis brevis muscle will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in depression severity clinician-rated | Hamilton rating scale for depression (HRSD-17); total scores ranging from 0 to 52. A higher score is indicative of greater depressive pathology | Screening, baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in depression severity self-report | Beck Depression Inventory (BDI-II); total scores ranging from 0 to 63. Higher total scores indicate more severe depressive symptoms. | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) |
| Changes in suicidal thoughts - clinician-rated |
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Inclusion Criteria:
Antidepressants:
Mood stabilizers:
Exclusion Criteria:
Contra-indications for TMS treatment:
Unipolar depression
Psychotic disorder (MINI-plus 5.0.0; DSM-IV codes 295.10, 295.20, .30, .40, .60, .70, .90, 297.10, 298.90); exceptions are: depression with psychotic features MINI-Plus 5.0.0; DSM code 296.23)
Current alcohol dependence (MINI-plus 5.0.0. DSM IV code 303.9) (in the last year)
Current substance abuse or dependence (DSM-IV codes 304.00-.90, 305.20 -.70) (in the last year), with the exception of nicotine and caffeine (DSM IV codes 305.10 and 305.90)
Suicide attempt within 6 months before the start of the study
Pregnancy or lactation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaat Hebbrecht, Dr | Contact | 15304048 | +32 | kaat.hebbrecht@emmaus.be |
| Bernard Sabbe, PhD | Contact | 15304034 | +32 | bernard.sabbe@ua.ac.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Brussels | Not yet recruiting | Brussels | 1000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15664172 | Background | Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Sham cTBS | Device | The sham coil has been specifically developed to mimic the real one but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. |
|
Columbia-suicide severity rating scale (total score ranges from 0 to 25; a higher score represent a higher intensity of suicidality) |
| Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) |
| Changes in cognitive symptoms (1) | Continuous performance test (CPT), a measure of a person's sustained and selective attention: d-prime (the quotient of hits/false alarms that indicate the response sensitivity for discrimination of target from nontarget stimuli). Greater scores represent better ability to distinguish and detect X and non-X stimuli (better sustained attention) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) |
| Changes in cognitive symptoms (2) | Symbol Digit Substitution Test (SDST), examining processing speed. Differentiating between the cognitive and the psychomotor processes of slowing (matching time and writing time; msec) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) |
| Changes in cognitive symptoms (3) | Stroop test; examining response inhibition (Stroop response interference score) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) |
| Changes in psychomotor symptoms (1) | CORE assessment of psychomotor functioning; total score ranging from 0 to 54. A higher score is indicative of psychomotor impairment (a score of 21 or more is indicative of melancholic depression) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) |
| Changes in psychomotor symptoms (2) | Accelometer tool (MotionWatch 8®, CamNtech, Cambridge, UK; measuring gross motor performance): total day activity level (counts per hour). Lower values indicate reduction in gross motor activity. *Cut-off levels from a control group are being collected in another research project of this research group. | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) |
| Changes in psychomotor symptoms (3) | Line-copying task (LCT): initiation and movement time (msec) | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) |
| Change in biological markers (1) | Plasma levels of C reactive protein (CRP) | Baseline and 10 days after cTBS or sham (+/- day 14) |
| Change in biological markers (2) | Cytokines (pg/ml) | Baseline and 10 days after cTBS or sham (+/- day 14) |
| Change in biological markers (3) | Kynurenines tryptophan catabolites (TRYCAT) levels (mmol/l) | Baseline and 10 days after cTBS or sham (+/- day 14) |
| Change in biological markers (4) | Brain-derived neurotrophic factor (BDNF; ng/ml) | Baseline and 10 days after cTBS or sham (+/- day 14) |
| Differences in adverse events following cTBS or sham - self report | Adverse effects questionnaire | 3 days after cTBS or sham (+/- day 7) |
| Differences in development of (hypo)manic symptoms | Young mania rating scale (YMRS): evaluates the presence and severity of mania. The score ranges from 0 to 60. Scores higher than 12 are indicative for mania, scores of 2 or lower indicate euthymia. | Baseline, 3 days after cTBS or sham (+/- day 7), 10 days after cTBS or sham (+/- day 14) |
| University Psychiatric Hospital Duffel | Recruiting | Duffel | 2570 | Belgium |
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