Clinical trial NCT01832805: Theta Burst Study Ghent
Official title: The Effects of Thetaburst Stimulation in Treatment Resistant Unipolar Depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unipolar Major Depression
Keywords: depression
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2013-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Depression severity in Theta burst treatment at baseline.
timeFrame: At baseline.
measure: Depression severity of Theta burst treatment after 1 week of treatment.
timeFrame: After 1 week of TBS-rTMS/sham treatment.
measure: Depression severity will be assessed at the end of the final second week of the stimulation protocol.
timeFrame: At the end of the final second week of the stimulation protocol.
measure: Depression severity will be assessed two weeks after stimulation.
timeFrame: Two weeks after stimulation.
measure: Suicidal ideation will be assessed at baseline.
timeFrame: At baseline.
measure: Suicidal ideation will be assessed after 1 week of treatment.
timeFrame: After 1 week of TBS-rTMS/sham treatment.
measure: Suicidal ideation will be assessed at the end of the final second week of the stimulation protocol.
timeFrame: At the end of the final second week of the stimulation protocol.
measure: Suicidal ideation will be assessed two weeks after stimulation.
timeFrame: Two weeks after stimulation.
Secondary outcomes:
measure: Resting state functional connectivity; diffusion MRI at baseline.
timeFrame: At baseline.
measure: Resting state functional connectivity; diffusion MRI after 1 week of treatment.
timeFrame: After 1 week of TBS-rTMS/sham treatment.
measure: Resting state functional connectivity; diffusion MRI at the end of the final second week of the stimulation protocol.
timeFrame: At the end of the final second week of the stimulation protocol.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Stefanie Desmyter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu GR, Duprat R, Baeken C. Accelerated iTBS changes perfusion patterns in medication resistant depression. J Affect Disord. 2022 Jun 1;306:276-280. doi: 10.1016/j.jad.2022.03.036. Epub 2022 Mar 16.
citation: Wu GR, Baeken C. Individual interregional perfusion between the left dorsolateral prefrontal cortex stimulation targets and the subgenual anterior cortex predicts response and remission to aiTBS treatment in medication-resistant depression: The influence of behavioral inhibition. Brain Stimul. 2022 Jan-Feb;15(1):182-189. doi: 10.1016/j.brs.2021.12.003. Epub 2021 Dec 10.
citation: Baeken C, van Beek V, Vanderhasselt MA, Duprat R, Klooster D. Cortical Thickness in the Right Anterior Cingulate Cortex Relates to Clinical Response to Left Prefrontal Accelerated Intermittent Theta Burst Stimulation: An Exploratory Study. Neuromodulation. 2021 Jul;24(5):938-949. doi: 10.1111/ner.13380. Epub 2021 Mar 31.
citation: Baeken C, Wu G, Sackeim HA. Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion. Brain Stimul. 2020 Sep-Oct;13(5):1211-1217. doi: 10.1016/j.brs.2020.05.015. Epub 2020 Jun 5.
citation: Klooster DC, Vos IN, Caeyenberghs K, Leemans A, David S, Besseling RM, Aldenkamp AP, Baeken C. Indirect frontocingulate structural connectivity predicts clinical response to accelerated rTMS in major depressive disorder. J Psychiatry Neurosci. 2020 Jul 1;45(4):243-252. doi: 10.1503/jpn.190088.
citation: Wu GR, Wang X, Baeken C. Baseline functional connectivity may predict placebo responses to accelerated rTMS treatment in major depression. Hum Brain Mapp. 2020 Feb 15;41(3):632-639. doi: 10.1002/hbm.24828. Epub 2019 Oct 21.
citation: Baeken C, Wu GR, van Heeringen K. Placebo aiTBS attenuates suicidal ideation and frontopolar cortical perfusion in major depression. Transl Psychiatry. 2019 Jan 29;9(1):38. doi: 10.1038/s41398-019-0377-x.
citation: Baeken C, Duprat R, Wu GR, De Raedt R, van Heeringen K. Subgenual Anterior Cingulate-Medial Orbitofrontal Functional Connectivity in Medication-Resistant Major Depression: A Neurobiological Marker for Accelerated Intermittent Theta Burst Stimulation Treatment? Biol Psychiatry Cogn Neurosci Neuroimaging. 2017 Oct;2(7):556-565. doi: 10.1016/j.bpsc.2017.01.001. Epub 2017 Jan 20.
citation: Desmyter S, Duprat R, Baeken C, Van Autreve S, Audenaert K, van Heeringen K. Accelerated Intermittent Theta Burst Stimulation for Suicide Risk in Therapy-Resistant Depressed Patients: A Randomized, Sham-Controlled Trial. Front Hum Neurosci. 2016 Sep 27;10:480. doi: 10.3389/fnhum.2016.00480. eCollection 2016.