Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression

Not Applicable

Terminated

• Conditions: Bipolar Depression
• Interventions: Device: active iTBS; Device: sham iTBS

• Registration Number: NCT02740244
• Lead Sponsor: Hôpital le Vinatier

Brief Summary

The aim is to evaluate the evaluate the clinical interest and the safety of repetitive transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar disorder.

Detailed Description

Methods: A double-blind randomized sham-controlled pilot study will be conducted in 40 patients with bipolar treatment-resistant depression receiving either active (n=20) or sham (n=20) iTBS over the left dorsolateral prefrontal cortex.

Depression severity will be assessed by an investigator blinded to iTBS condition before and after 10 to 30 iTBS sessions depending on remission onset. Remission will be defined as Beck Depression Inventory, BDI score\<10.

Objective/Hypothesis: The investigators hypothesized the superiority of active iTBS over sham ITBS

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-02
• Study Completion: 2015-01
• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, DSM-IV criteria
• Montgomery and Asberg depression scale > 20

Exclusion Criteria

• other psychiatric features, rapid cycles
• Benzodiazepines intake
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active iTBS	active iTBS	Participants will receive 10 to 30 sessions of active intermittent theta burst stimulation (iTBS) consisting in delivering 2 s train of bursts containing three pulses at 50 Hz repeated each 200 ms every 10 s (iTBS). Each iTBS session contained 990 pulses and lasted 6 min. Stimulation intensity will be set at 80% of the patient's resting motor threshold. iTBS will be applied twice per day, with at least three hours between each session. Ten to 30 sessions will be delivered until patient achieved remission (i.e., 13-item Beck Depression Inventory (BDI13) score \< 10). iTBS will be applied over the left dorsolateral prefrontal cortex (DLPFC) according to the individual's 3D-T1 MRI.
sham iTBS	sham iTBS	The same protocol (location, intensity, parameters of stimulation) will be applied using a commercial sham coil.

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory	2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks)	Self-reported clinical scale with 13 items