TBS Ghent: Theta Burst Study Ghent

Sponsor

University Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT01832805

Collaborator

University Hospital, Ghent (Other)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unipolar Major Depression	Other: Theta burst stimulation.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Thetaburst Stimulation in Treatment Resistant Unipolar Depressed Patients

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Theta burst stimulation Specific developed sham coil.	Other: Theta burst stimulation. 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.

Arm

Intervention/Treatment

Experimental: Theta burst stimulation

Specific developed sham coil.

Other: Theta burst stimulation.

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.

Outcome Measures

Primary Outcome Measures

Depression severity in Theta burst treatment at baseline. [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).
Depression severity of Theta burst treatment after 1 week of treatment. [After 1 week of TBS-rTMS/sham treatment.]
Depression severity will be assessed, using the 21-item Beck Depression Inventory (BDI-II) and the 17-item Hamilton Depression Rating Scale (HDRS).
Depression severity will be assessed at the end of the final second week of the stimulation protocol. [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).
Depression severity will be assessed two weeks after stimulation. [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).
Suicidal ideation will be assessed at baseline. [At baseline.]
Suicidal ideation will be assessed with the suicidal ideation scale (SSI).
Suicidal ideation will be assessed after 1 week of treatment. [After 1 week of TBS-rTMS/sham treatment.]
Suicidal ideation will be assessed using the suicidal ideation scale (SSI).
Suicidal ideation will be assessed at the end of the final second week of the stimulation protocol. [At the end of the final second week of the stimulation protocol.]
Suicidal ideation will be assessed using the suicidal ideation scale (SSI).
Suicidal ideation will be assessed two weeks after stimulation. [Two weeks after stimulation.]
Suicidal ideation will be assessed using the suicidal ideation scale (SSI).

Secondary Outcome Measures

Resting state functional connectivity; diffusion MRI at baseline. [At baseline.]
Siemens 3T MRI.
Resting state functional connectivity; diffusion MRI after 1 week of treatment. [After 1 week of TBS-rTMS/sham treatment.]
Siemens 3T MRI.
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.]
Siemens 3T MRI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University Hospital	Ghent		Belgium	9000

Sponsors and Collaborators

University Ghent
University Hospital, Ghent

Investigators

Principal Investigator: Stefanie Desmyter, MD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

University Ghent

ClinicalTrials.gov Identifier:

NCT01832805

Other Study ID Numbers:

2013/392

First Posted:

Apr 16, 2013

Last Update Posted:

Feb 2, 2017

Last Verified:

Feb 1, 2017

Keywords provided by University Ghent

depression

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Feb 2, 2017