Theta Burst Study Ghent

Not Applicable

Completed

• Conditions: Unipolar Major Depression
• Interventions: Other: Theta burst stimulation.

• Registration Number: NCT01832805
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-16
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Theta burst stimulation	Theta burst stimulation.	Specific developed sham coil.

Primary Outcome Measures

Name	Time	Method
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).
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).
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium