NCT01832805

Theta Burst Study Ghent

The Effects of Thetaburst Stimulation in Treatment Resistant Unipolar Depressed Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Unipolar Major Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-04-16
• Last updated: 2017-02-02

Locations

1 site across 1 country: Belgium