NCT01832805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

2.7 years

First QC Date

April 9, 2013

Last Update Submit

February 1, 2017

Conditions

Unipolar Major Depression

Keywords

depression

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (3)

  • Resting state functional connectivity; diffusion MRI at baseline.

    At baseline.

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

    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.

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

Study Arms (1)

Theta burst stimulation

EXPERIMENTAL

Specific developed sham coil.

Other: Theta burst stimulation.

Interventions

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.

Theta burst stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (9)

  • 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.

    PMID: 35306123DERIVED

  • 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.

    PMID: 34902623DERIVED

  • 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.

    PMID: 33788975DERIVED

  • 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.

    PMID: 32512184DERIVED

  • 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.

    PMID: 31990490DERIVED

  • 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.

    PMID: 31633261DERIVED

  • 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.

    PMID: 30696807DERIVED

  • 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.

    PMID: 29560909DERIVED

  • 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.

    PMID: 27729854DERIVED

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Stefanie Desmyter, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 16, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 2, 2017

Record last verified: 2017-02

Locations

BE(1)