Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression (iTBS-BIP)

Hôpital le Vinatier

Status: Terminated

Conditions: Bipolar Depression

Treatments: Device: active iTBS; Device: sham iTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT02740244

1018 rTMS DEP BIP

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

active iTBS

Active Comparator group

Description:

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.

Treatment:

Device: active iTBS

sham iTBS

Sham Comparator group

Description:

The same protocol (location, intensity, parameters of stimulation) will be applied using a commercial sham coil.

Treatment:

Device: sham iTBS