Theta Burst Study Ghent (TBS Ghent)

February 1, 2017 updated by: University Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression severity in Theta burst treatment at baseline.
Time Frame: 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.
Time Frame: 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).
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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: After 1 week of TBS-rTMS/sham 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.
Time Frame: 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.
Time Frame: Two weeks after stimulation.
Suicidal ideation will be assessed using the suicidal ideation scale (SSI).
Two weeks after stimulation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting state functional connectivity; diffusion MRI at baseline.
Time Frame: At baseline.
Siemens 3T MRI.
At baseline.
Resting state functional connectivity; diffusion MRI after 1 week of treatment.
Time Frame: After 1 week of TBS-rTMS/sham treatment.
Siemens 3T MRI.
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.
Time Frame: At the end of the final second week of the stimulation protocol.
Siemens 3T MRI.
At the end of the final second week of the stimulation protocol.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

University Hospital, Ghent

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/392

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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