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NCT Number: NCT01832805

Theta Burst Study Ghent

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.

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Key information

Conditions

Unipolar Major Depression Behavior Behavioral Symptoms Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. Suicidal ideation will be assessed at baseline.

    Time frame: At baseline.

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

  6. 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).

  7. 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).

  8. 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).

Secondary outcomes

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

    Time frame: At baseline.

    Siemens 3T MRI.

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

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

    Siemens 3T MRI.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • University Hospital, Ghent

Registry information

Official study title

The Effects of Thetaburst Stimulation in Treatment Resistant Unipolar Depressed Patients

Acronym: TBS Ghent

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 16, 2013
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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