Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression

NCT02740244 | Terminated

• 1 other identifier: 1018 rTMS DEP BIP
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory

  Self-reported clinical scale with 13 items

  2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks)

Study Arms (2)

active iTBS

ACTIVE COMPARATOR

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.

Device: active iTBS

sham iTBS

SHAM COMPARATOR

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

Device: sham iTBS

Interventions

active iTBS DEVICE

Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a figure-eight coil (MCF-B65)

Also known as: intermittent Theta Burst stimulation; rTMS stimulator, rTMS

active iTBS

sham iTBS DEVICE

Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a sham figure-eight coil (MCF-P-B65)

Also known as: sham intermittent Theta Burst stimulation; sham rTMS

sham iTBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• David Szekely, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 15, 2016
• Study Start: January 1, 2011
• Primary Completion: February 1, 2011
• Study Completion: January 1, 2015
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share