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Unipolar Major DepressionTBS GhentNCT01832805

Theta Burst Study Ghent

A study testing Theta burst stimulation. in people with Unipolar Major Depression, run by University Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Unipolar Major Depression
What is being tested?
Theta burst stimulation.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBelgium
Study dates
Apr 2013to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • antidepressant-free unipolar depression
  • age between 18 and 65 years
  • right handed
  • at least stage I treatment resistant

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Ghent University Hospital

    Ghent, 9000

Other trials in Belgium

About this study

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

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.

Being tested
Theta burst stimulation.
Keywords
depression
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Theta burst stimulation.Other

    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.

Study groups in NCT01832805
Study groupRoleWhat they receive
Theta burst stimulationExperimentalSpecific developed sham coil.
Receives: Other: Theta burst stimulation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At baseline.

  2. 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).

    Measured: After 1 week of TBS-rTMS/sham treatment.

  3. 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).

    Measured: At the end of the final second week of the stimulation protocol.

  4. 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).

    Measured: Two weeks after stimulation.

  5. Suicidal ideation will be assessed at baseline.

    Suicidal ideation will be assessed with the suicidal ideation scale (SSI).

    Measured: At baseline.

  6. Suicidal ideation will be assessed after 1 week of treatment.

    Suicidal ideation will be assessed using the suicidal ideation scale (SSI).

    Measured: After 1 week of TBS-rTMS/sham treatment.

  7. 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).

    Measured: At the end of the final second week of the stimulation protocol.

  8. Suicidal ideation will be assessed two weeks after stimulation.

    Suicidal ideation will be assessed using the suicidal ideation scale (SSI).

    Measured: Two weeks after stimulation.

Secondary outcomes (3)

  1. Resting state functional connectivity; diffusion MRI at baseline.

    Siemens 3T MRI.

    Measured: At baseline.

  2. Resting state functional connectivity; diffusion MRI after 1 week of treatment.

    Siemens 3T MRI.

    Measured: After 1 week of TBS-rTMS/sham treatment.

  3. Resting state functional connectivity; diffusion MRI at the end of the final second week of the stimulation protocol.

    Siemens 3T MRI.

    Measured: At the end of the final second week of the stimulation protocol.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01832805
Sponsor's protocol ID
2013/392
Acronym
TBS Ghent
Status last verified
Feb 2017
First submitted
9 Apr 2013
Last updated
2 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 35306123

  • 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.

    PubMed 34902623

  • 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.

    PubMed 33788975

  • 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.

    PubMed 32512184

  • 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.

    PubMed 31990490

  • 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.

    PubMed 31633261

  • 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.

    PubMed 30696807

  • 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.

    PubMed 29560909

  • 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.

    PubMed 27729854

Questions about this trial

What is this clinical trial studying?

A study testing Theta burst stimulation. in people with Unipolar Major Depression, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression severity in Theta burst treatment at baseline. (time frame: At baseline.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01832805, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.

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