Depressive Disorder, MajoraiTBS2-GhentNCT03288675

Stepped Care AiTBS 2 Depression Study (Ghent)

A study testing aiTBS, CCT and SSRI in people with Depressive Disorder, Major and Treatment Resistant Depression, run by University Hospital, 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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Depressive Disorder, Major, Treatment Resistant Depression, Melancholia
What is being tested?: aiTBS, CCT and SSRI
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteBelgium
Study dates: 5 Oct 2017to 31 Dec 2023
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 major depression with melancholic features
Not responding to at least two trials with an antidepressant
Aged between 18-65 years old

Who cannot join

Depression with bipolar/psychotic features
Dysthymia
Severe personality disorders
Active substance abuse/dependence within a year prior to inclusion
Pregnancy or without effective anticonception for the duration of the trial
ECT non-responder

Show all 14Show fewer

No response to more than 9 antidepressants
Any neurological condition
Any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker)
Any implanted metal device in the head region
Current or past history of epilepsy
Neurosurgical interventions
Known allergic reaction to radiotracers or associated compounds
Healthy volunteers may be accepted as control subjects.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

University Hospital Ghent
Ghent, East-Flanders, 9000

Other trials in Belgium

About this study

Official title: The Effects of Accelerated Intermittent Thetaburst Stimulation Followed by a Cognitive Control Training in Treatment Resistant Unipolar Depressed Patients

Antidepressant-free unipolar melancholic depressed patients (at least stage 2 treatment-resistant) will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews. 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.

STEP 1: Patients will be treated with in total 20 accelerated intermittent Theta Burst Stimulation (aiTBS) sessions (3000 pulses/session) over the left dorsolateral prefrontal cortex, which will be spread over 4 days. On each stimulation day, a given patient will receive 5 sessions with a between-session delay of 15 minutes. Patients will be randomized to receive either the real aiTBS or sham treatment (first week). However, the sham group will receive real aiTBS treatment with 10 days' time interval. The investigators expect that real aiTBS treatment and not sham will result in a significant and clinical meaningful response.

STEP 2: To optimize treatment and reduce relapse following the iTBS treatment, in a stepped care approach, all patients then continue with cognitive control training (CCT) ten days later. This CCT consists of 20 sessions, spread over 4 weeks. Patients will be randomized to receive either real CCT or a control training. During this follow-up treatment, all patients will be prescribed antidepressant medication (SSRI) again. As iTBS treatment effects are known to decline over time, the investigators expect that combining aiTBS with a follow-up CCT therapy will stabilize the clinical effects over time compared to receiving the iTBS treatment alone.

For baseline comparisons, patients will be closely matched for gender and age with never-depressed, medication-free healthy volunteers. No volunteer will undergo treatment.

Conditions: Depressive Disorder, Major, Treatment Resistant Depression, Melancholia
Being tested: aiTBS, CCT, SSRI
Keywords: Major depressive disorder, Treatment resistant depression, Accelerated intermittent thetaburst stimulation, Cognitive control training, Neuroimaging
Medical subject headings: Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Depressive Disorder

What participants receive

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

aiTBSDevice
Also called accelerated intermittent thetaburst stimulation
In the active aiTBS arm, the patients will receive 100 cycli of thetaburst trains of 2s, separated by an inter-train-interval of 6 seconds, delivered on the left dorsolateral prefrontal cortex (DLPFC; i.e. 3000 pulses per session). On each stimulation day, a given patient will receive 5 sessions with a between-session interval of 15 minutes. The treatment protocol of in total 20 aiTBS sessions will be spread over 4 days (i.e. 60.000 pulses in total). The sham coil has been specifically developed to mimic the real one.
CCTBehavioural
Also called cognitive control training
By training working memory processing, the CCT aims at modulating similar prefrontal cortex regions as being stimulated previously by aiTBS, namely the DLPFC. thereby possibly stabilizing clinical effects of aiTBS over time. In total 20 sessions of CCT vs. control training (of approximately 25 minutes per session), will be spread over a period of 4 weeks.
SSRIDrug
Also called selective serotonin reuptake inhibitor
All patients will be prescribed antidepressant medication (SSRI) again when starting the CCT (vs. control training).

Study groups in NCT03288675
Study group	Role	What they receive
Active aiTBS - active CCT+SSRI	Active comparator	Patients receive active aiTBS treatment in the first week, and starting from week 3 receive active CCT for a period of 4 weeks in combination with an antidepressant (SSRI) Receives: Device: aiTBS; Behavioral: CCT; Drug: SSRI
Active aiTBS - sham CCT+SSRI	Experimental	Patients receive active aiTBS treatment in the first week, and starting from week 3 receive a control training for a period of 4 weeks in combination with an antidepressant (SSRI) Receives: Device: aiTBS; Drug: SSRI
Sham aiTBS - aiTBS - active CCT+SSRI	Experimental	Patients receive sham aiTBS treatment in the first week, real aiTBS treatment in the third week, and starting from the fifth week receive CCT for a period of 4 weeks in combination with an antidepressant (SSRI) Receives: Device: aiTBS; Behavioral: CCT; Drug: SSRI
Sham aiTBS - aiTBS - sham CCT+SSRI	Experimental	Patients receive sham aiTBS treatment in the first week, real aiTBS treatment in the third week, and starting from the fifth week control training for a period of 4 weeks in combination with an antidepressant (SSRI) Receives: Device: aiTBS; Drug: SSRI

What is being measured

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

Changes in depression severity - clinician-rated
17-item Hamilton Rating Scale for Depression (HRSD)
Measured: Intake, baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up

Secondary outcomes (30)

Changes in depression severity - self-report
Beck Depression Inventory (BDI-II)
Measured: Intake, baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in suicidal thoughts - clinician-rated
Scale for suicidal ideation (SSI)
Measured: Intake, baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in melancholic features - clinician-rated
Clinical outcomes in routine evaluation (CORE)
Measured: Intake, baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in hopelessness - self-report
Beck hopelessness scale (BHS)
Measured: Baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in anxiety features - self-report
State/Trait Anxiety Inventory (STAI)
Measured: Baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in remission from depression - self-report
Remission from Depression Questionnaire (RDQ)
Measured: Baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in ruminative thinking (trait) - self-report
Ruminative Responses Scale (RRS)
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in hedonia - self-report
Temporal Experience of Pleasure Scale (TEPS)
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in anhedonia - self-report
Snaith-Hamilton Pleasure Scale (SHAPS)
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in perceived stress - self-report
Perceived Stress Scale (PSS)
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in responses to positive affect - self-report
Responses to Positive Affect Scale (RPA)
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in cognitive emotion regulation - self-report
Cognitive Emotion Regulation Questionnaire (CERQ)
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in temperament and character - self-report
Temperament and Character Inventory (TCI)
Measured: Intake, 10 days after aiTBS or sham (+/-D14)
Differences in adverse effects following aiTBS vs. sham - self-report
Adverse effects questionnaire
Measured: 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)]
Changes in regional grey matter volume using structural MRI
The analysis will be done using voxel-based morphometry
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Changes in regional white matter microstructure and structural connectivity
The analysis will be done using diffusion tensor imaging (DTI)
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Neuronal safety/ changes in neurometabolite concentrations in left-prefrontal tissues using MRS
The analysis will be evaluated using 1H MR spectroscopy
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Changes in functional activity connectivity at rest and during tasks in which self-referential social evaluations are presented via headphones in the scanner
The analysis will be evaluated using resting state and task fMRI
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Changes in state-dependent ruminative thinking due to hearing self-referential social evaluations presented via headphones in the scanner - self-report
Before entering the scanner, and following each resting state fMRI (i.e. before hearing self-referential social evaluations and after hearing these evaluations), perseverative thinking will be assessed using the perseverative thinking questionnaire (PTQ).
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Changes in state-dependent mood due to hearing self-referential social evaluations presented via headphones in the scanner - self-report
Before entering the scanner, and following each resting state fMRI (i.e. before hearing self-referential social evaluations and after hearing these evaluations), mood will be assessed using visual analogue scales (VAS).
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Changes in the regional 5-HT transporter system
C11 DASB PET
Measured: Baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14)
Changes in reward processing as measured with EEG /ERP
128 channel EEG during doors gambling task to assess effects on reward processing.
Measured: Baseline (D0), 10 days after active aiTBS in both groups (+/-D14 for the active group, +/-D28 for the sham group)
Evaluation of cognitive side-effects following iTBS vs. sham using the CANTAB battery
CANTAB battery administration (i.e. motor screening, delayed matching to sample, rapid visual information processing, one touch stockings of Cambridge, spatial working memory).
Measured: Baseline (D0), 3 days after aiTBS or sham (+/-D7)
Changes in reward processing - behavioral assessment
Cambridge Gambling Task (CGT; CANTAB battery)
Measured: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56)
Changes in working memory - behavioral assessment of near transfer
Non-adaptive PASAT (naPASAT)
Measured: Baseline (D0), 10 days after active aiTBS in both groups (+/-D14 for the active group, +/-D28 for the sham group), after CCT (+/-D42; for the sham group +/-D56)
Changes in state-dependent mood - self-report following naPASAT
Visual analogue scales (VAS) administered following completion of the naPASAT
Measured: Baseline (D0), 10 days after active aiTBS in both groups (+/-D14 for the active group, +/-D28 for the sham group), after CCT (+/-D42; for the sham group +/-D56)
Changes in spatial working memory - behavioral assessment of far transfer
Spatial working memory (SWT; CANTAB battery)
Measured: Baseline (D0), 10 days after active aiTBS in both groups (+/-D14 for the active group, +/-D28 for the sham group), after CCT (+/-D42; for the sham group +/-D56)
Changes in state-dependent mood during CCT vs. control training
Visual analogue scales (VAS) administered following completion of the CCT (or control training)
Measured: Following each of the 20 CCT or control trainings (spread over +/- D15 up to D42 for the active group; spread over +/- D29 up to D56 for the sham group)
Predictive influence of single nucleotide polymorphisms on treatment outcome - genetics using a saliva sample
SNP analysis
Measured: At baseline (D0)
Predictive influence of treatment expectancy on treatment response - self-report
Credibility and Expectancy Questionnaire (CEQ)
Measured: After the first aiTBS or sham session (D1), after the first CCT or control session (+/- D15 for the active group, +/-D29 for the sham group)

Timeline

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

5 Oct 201731 Dec 2023

First posted20 Sep 2017
Study start5 Oct 2017
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03288675
Sponsor's protocol ID: BC-1812
Acronym: aiTBS2-Ghent
Status last verified: Sep 2024
First submitted: 14 Jul 2017
Last updated: 19 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depressive Disorder, Major trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Accelerated Intermittent Thetaburst Stimulation Followed by a Cognitive Control Training in Treatment Resistant Unipolar Depressed Patients
ClinicalTrials.gov ID: NCT03288675
Acronym / sponsor ID: aiTBS2-Ghent / BC-1812
Conditions: Depressive Disorder, Major, Treatment Resistant Depression, Melancholia
Keywords: Major depressive disorder, Treatment resistant depression, Accelerated intermittent thetaburst stimulation, Cognitive control training, Neuroimaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Study start: 5 Oct 2017 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 20 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

For baseline comparisons, patients will be closely matched for gender and age with never-depressed, medication-free healthy volunteers. No volunteer will undergo treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Active aiTBS - active CCT+SSRI	Active comparator	Device: aiTBS, Behavioral: CCT, Drug: SSRIPatients receive active aiTBS treatment in the first week, and starting from week 3 receive active CCT for a period of 4 weeks in combination with an antidepressant (SSRI)
Active aiTBS - sham CCT+SSRI	Experimental	Device: aiTBS, Drug: SSRIPatients receive active aiTBS treatment in the first week, and starting from week 3 receive a control training for a period of 4 weeks in combination with an antidepressant (SSRI)
Sham aiTBS - aiTBS - active CCT+SSRI	Experimental	Device: aiTBS, Behavioral: CCT, Drug: SSRIPatients receive sham aiTBS treatment in the first week, real aiTBS treatment in the third week, and starting from the fifth week receive CCT for a period of 4 weeks in combination with an antidepressant (SSRI)
Sham aiTBS - aiTBS - sham CCT+SSRI	Experimental	Device: aiTBS, Drug: SSRIPatients receive sham aiTBS treatment in the first week, real aiTBS treatment in the third week, and starting from the fifth week control training for a period of 4 weeks in combination with an antidepressant (SSRI)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Antidepressant-free unipolar major depression with melancholic features
Not responding to at least two trials with an antidepressant
Aged between 18-65 years old

Key exclusion criteria (14 listed)

Depression with bipolar/psychotic features
Dysthymia
Severe personality disorders
Active substance abuse/dependence within a year prior to inclusion
Pregnancy or without effective anticonception for the duration of the trial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
aiTBSAlso: accelerated intermittent thetaburst stimulationIn the active aiTBS arm, the patients will receive 100 cycli of thetaburst trains of 2s, separated by an inter-train-interval of 6 seconds, delivered on the left dorsolateral prefrontal cortex (DLPFC; i.e. 3000 pulses per session). On each stimulation day, a given patient will receive 5 sessions with a between-session interval of 15 minutes. The treatment protocol of in total 20 aiTBS sessions will be spread over 4 days (i.e. 60.000 pulses in total). The sham coil has been specifically developed to mimic the real one.	Device	Active aiTBS - active CCT+SSRI, Active aiTBS - sham CCT+SSRI, Sham aiTBS - aiTBS - active CCT+SSRI, Sham aiTBS - aiTBS - sham CCT+SSRI
CCTAlso: cognitive control trainingBy training working memory processing, the CCT aims at modulating similar prefrontal cortex regions as being stimulated previously by aiTBS, namely the DLPFC. thereby possibly stabilizing clinical effects of aiTBS over time. In total 20 sessions of CCT vs. control training (of approximately 25 minutes per session), will be spread over a period of 4 weeks.	Behavioural	Active aiTBS - active CCT+SSRI, Sham aiTBS - aiTBS - active CCT+SSRI
SSRIAlso: selective serotonin reuptake inhibitorAll patients will be prescribed antidepressant medication (SSRI) again when starting the CCT (vs. control training).	Drug	Active aiTBS - active CCT+SSRI, Active aiTBS - sham CCT+SSRI, Sham aiTBS - aiTBS - active CCT+SSRI, Sham aiTBS - aiTBS - sham CCT+SSRI

Primary outcome

Changes in depression severity - clinician-rated
Time frame: Intake, baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
17-item Hamilton Rating Scale for Depression (HRSD)

30 secondary outcomes

Changes in depression severity - self-report
Time frame: Intake, baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in suicidal thoughts - clinician-rated
Time frame: Intake, baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in melancholic features - clinician-rated
Time frame: Intake, baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in hopelessness - self-report
Time frame: Baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in anxiety features - self-report
Time frame: Baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in remission from depression - self-report
Time frame: Baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in ruminative thinking (trait) - self-report
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in hedonia - self-report
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in anhedonia - self-report
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in perceived stress - self-report
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in responses to positive affect - self-report
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in cognitive emotion regulation - self-report
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up
Changes in temperament and character - self-report
Time frame: Intake, 10 days after aiTBS or sham (+/-D14)
Differences in adverse effects following aiTBS vs. sham - self-report
Time frame: 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)]
Changes in regional grey matter volume using structural MRI
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Changes in regional white matter microstructure and structural connectivity
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Neuronal safety/ changes in neurometabolite concentrations in left-prefrontal tissues using MRS
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Changes in functional activity connectivity at rest and during tasks in which self-referential social evaluations are presented via headphones in the scanner
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Changes in state-dependent ruminative thinking due to hearing self-referential social evaluations presented via headphones in the scanner - self-report
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Changes in state-dependent mood due to hearing self-referential social evaluations presented via headphones in the scanner - self-report
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14)
Changes in the regional 5-HT transporter system
Time frame: Baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14)
Changes in reward processing as measured with EEG /ERP
Time frame: Baseline (D0), 10 days after active aiTBS in both groups (+/-D14 for the active group, +/-D28 for the sham group)
Evaluation of cognitive side-effects following iTBS vs. sham using the CANTAB battery
Time frame: Baseline (D0), 3 days after aiTBS or sham (+/-D7)
Changes in reward processing - behavioral assessment
Time frame: Baseline (D0), 10 days after aiTBS or sham (+/-D14), [for the sham group 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56)
Changes in working memory - behavioral assessment of near transfer
Time frame: Baseline (D0), 10 days after active aiTBS in both groups (+/-D14 for the active group, +/-D28 for the sham group), after CCT (+/-D42; for the sham group +/-D56)
Changes in state-dependent mood - self-report following naPASAT
Time frame: Baseline (D0), 10 days after active aiTBS in both groups (+/-D14 for the active group, +/-D28 for the sham group), after CCT (+/-D42; for the sham group +/-D56)
Changes in spatial working memory - behavioral assessment of far transfer
Time frame: Baseline (D0), 10 days after active aiTBS in both groups (+/-D14 for the active group, +/-D28 for the sham group), after CCT (+/-D42; for the sham group +/-D56)
Changes in state-dependent mood during CCT vs. control training
Time frame: Following each of the 20 CCT or control trainings (spread over +/- D15 up to D42 for the active group; spread over +/- D29 up to D56 for the sham group)
Predictive influence of single nucleotide polymorphisms on treatment outcome - genetics using a saliva sample
Time frame: At baseline (D0)
Predictive influence of treatment expectancy on treatment response - self-report
Time frame: After the first aiTBS or sham session (D1), after the first CCT or control session (+/- D15 for the active group, +/-D29 for the sham group)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chris Baeken, Prof. principal investigator

Ghent University, University Hospital Ghent

Ernst Koster, Prof. principal investigator

University Ghent

Rudi De Raedt, Prof. principal investigator

University Ghent

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing aiTBS, CCT and SSRI in people with Depressive Disorder, Major and Treatment Resistant Depression, run by University Hospital, 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 3 inclusion and 14 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 19 Sep 2024. 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?

Changes in depression severity - clinician-rated (time frame: Intake, baseline (D0), 3 days after aiTBS or sham (+/-D7), 10 days after aiTBS or sham (+/-D14), [for the sham group 3 days (+/-D21) and 10 days after active aiTBS (+/-D28)], after CCT (+/-D42; for the sham group +/-D56), 3 & 6 months follow-up). 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 NCT03288675.

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 19 Sep 2024.