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

Primary Purpose

Bipolar Depression

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active iTBS
sham iTBS
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bipolar Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    active iTBS

    sham iTBS

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    Beck Depression Inventory
    Self-reported clinical scale with 13 items

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2016
    Last Updated
    July 31, 2018
    Sponsor
    Hôpital le Vinatier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02740244
    Brief Title
    Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression
    Acronym
    iTBS-BIP
    Official Title
    Effects of Intermittent Theta Burst Stimulation Applied Over the Left Dorsolateral Prefrontal Cortex in Patients With Treatment-resistant Bipolar Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    difficulties of recruitment
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hôpital le Vinatier

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Depression

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    active iTBS
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    sham iTBS
    Arm Type
    Sham Comparator
    Arm Description
    The same protocol (location, intensity, parameters of stimulation) will be applied using a commercial sham coil.
    Intervention Type
    Device
    Intervention Name(s)
    active iTBS
    Other Intervention Name(s)
    intermittent Theta Burst stimulation; rTMS stimulator, rTMS
    Intervention Description
    Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a figure-eight coil (MCF-B65)
    Intervention Type
    Device
    Intervention Name(s)
    sham iTBS
    Other Intervention Name(s)
    sham intermittent Theta Burst stimulation; sham rTMS
    Intervention Description
    Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a sham figure-eight coil (MCF-P-B65)
    Primary Outcome Measure Information:
    Title
    Beck Depression Inventory
    Description
    Self-reported clinical scale with 13 items
    Time Frame
    2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Szekely, MD
    Organizational Affiliation
    University Hospital, Grenoble
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression

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