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Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Magstim Rapid2 Stimulator
Magstim Rapid2 Stimulator
Sponsored by
Douglas Mental Health University Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Repetitive transcranial magnetic stimulation, Bipolar depression, Randomized trial, rTMS, Neuromodulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women aged 18 to 70 years
  • Current major depressive episode (MDE) in the context of a bipolar disorder type I or II (according to the DSM-IV-TR) that has not improved after more than 2 adequate pharmacological trial(s) in the current episode (failure is defined as a lack of significant clinical improvement after the use of standard mood stabilizers, atypical antipsychotics and/or antidepressants given at their minimum effective dosage or higher for at least 4 weeks of duration)
  • Baseline score ≥ 13 on the Quick Inventory of Depressive Symptomatology - Clinician-Administered (QIDS-C), i.e., a MDE of at least moderate intensity

Exclusion Criteria:

  • Psychotic features in the current episode
  • Lifetime history of a non-mood-related psychotic disorder
  • Substance or alcohol abuse/dependence in the past 6 months
  • Unstable medical disease (e.g., cardiovascular, renal)
  • Presence of mood cycles of < 30 days duration
  • Pregnancy and/or lactation
  • Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy or convulsion, metallic head implant)
  • Hearing loss

Sites / Locations

  • Neuromodulation Research Clinic, Douglas Mental Health University Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Frequency rTMS

Low Frequency rTMS

Arm Description

10 Hz in 75 trains of 4-seconds duration, with 26-seconds intertrain intervals (3,000 pulses per session) at 120% of the rMT.

1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT.

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS)
Pre-post neuromodulation treatment reduction on the scores of the MADRS

Secondary Outcome Measures

21-item Hamilton Depression Rating Scale (HAM-D21)
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean HAM-D21 score. Remission will be considered as a HAM-D21 score ≤ 8.
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean QIDS-SR score. Remission will be considered as a QIDS-SR score ≤ 5.
Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean QIDS-C score. Remission will be considered as a QIDS-C score ≤ 5.
Montogmery-Asberg Depression Rating Scale (MADRS)
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean MADRS score. Remission will be defined as a MADRS score ≤ 6.

Full Information

First Posted
April 24, 2012
Last Updated
May 26, 2015
Sponsor
Douglas Mental Health University Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01586793
Brief Title
Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression
Official Title
A Randomized Trial Comparing the Effectiveness and Tolerability of High and Low Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression: An Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Douglas Mental Health University Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this randomized, single-blind trial is to evaluate the effectiveness and tolerability of high frequency or low frequency repetitive transcranial magnetic stimulation (rTMS) in patients with resistant bipolar depression. Patients will be assigned to receive either high or low frequency rTMS for 20 consecutive workdays (4 weeks). 10 Hz (high) frequency rTMS and 1 Hz (low) frequency rTMS will be given over the left or right dorsolateral prefrontal cortex (DLPFC), respectively. Patients will be assessed with several psychometric instruments at baseline, and at weeks 5 and 9.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Repetitive transcranial magnetic stimulation, Bipolar depression, Randomized trial, rTMS, Neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Frequency rTMS
Arm Type
Experimental
Arm Description
10 Hz in 75 trains of 4-seconds duration, with 26-seconds intertrain intervals (3,000 pulses per session) at 120% of the rMT.
Arm Title
Low Frequency rTMS
Arm Type
Experimental
Arm Description
1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT.
Intervention Type
Device
Intervention Name(s)
Magstim Rapid2 Stimulator
Other Intervention Name(s)
1 Hz rTMS
Intervention Description
1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT.
Intervention Type
Device
Intervention Name(s)
Magstim Rapid2 Stimulator
Other Intervention Name(s)
10 Hz rTMS
Intervention Description
10 Hz in 75 trains of 4-seconds duration, with 26-seconds intertrain intervals (3,000 pulses per session) at 120% of the rMT.
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
Pre-post neuromodulation treatment reduction on the scores of the MADRS
Time Frame
Week 5
Secondary Outcome Measure Information:
Title
21-item Hamilton Depression Rating Scale (HAM-D21)
Description
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean HAM-D21 score. Remission will be considered as a HAM-D21 score ≤ 8.
Time Frame
Week 5
Title
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Description
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean QIDS-SR score. Remission will be considered as a QIDS-SR score ≤ 5.
Time Frame
Week 5
Title
Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)
Description
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean QIDS-C score. Remission will be considered as a QIDS-C score ≤ 5.
Time Frame
Week 5
Title
Montogmery-Asberg Depression Rating Scale (MADRS)
Description
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean MADRS score. Remission will be defined as a MADRS score ≤ 6.
Time Frame
Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women aged 18 to 70 years Current major depressive episode (MDE) in the context of a bipolar disorder type I or II (according to the DSM-IV-TR) that has not improved after more than 2 adequate pharmacological trial(s) in the current episode (failure is defined as a lack of significant clinical improvement after the use of standard mood stabilizers, atypical antipsychotics and/or antidepressants given at their minimum effective dosage or higher for at least 4 weeks of duration) Baseline score ≥ 13 on the Quick Inventory of Depressive Symptomatology - Clinician-Administered (QIDS-C), i.e., a MDE of at least moderate intensity Exclusion Criteria: Psychotic features in the current episode Lifetime history of a non-mood-related psychotic disorder Substance or alcohol abuse/dependence in the past 6 months Unstable medical disease (e.g., cardiovascular, renal) Presence of mood cycles of < 30 days duration Pregnancy and/or lactation Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy or convulsion, metallic head implant) Hearing loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Berlim, MD, MSc
Organizational Affiliation
Douglas Mental Health University Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuromodulation Research Clinic, Douglas Mental Health University Institute
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4H1R3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19133969
Citation
Dell'Osso B, Mundo E, D'Urso N, Pozzoli S, Buoli M, Ciabatti M, Rosanova M, Massimini M, Bellina V, Mariotti M, Altamura AC. Augmentative repetitive navigated transcranial magnetic stimulation (rTMS) in drug-resistant bipolar depression. Bipolar Disord. 2009 Feb;11(1):76-81. doi: 10.1111/j.1399-5618.2008.00651.x.
Results Reference
background
PubMed Identifier
12479689
Citation
Dolberg OT, Dannon PN, Schreiber S, Grunhaus L. Transcranial magnetic stimulation in patients with bipolar depression: a double blind, controlled study. Bipolar Disord. 2002;4 Suppl 1:94-5. doi: 10.1034/j.1399-5618.4.s1.41.x. No abstract available.
Results Reference
background
PubMed Identifier
12656937
Citation
Nahas Z, Kozel FA, Li X, Anderson B, George MS. Left prefrontal transcranial magnetic stimulation (TMS) treatment of depression in bipolar affective disorder: a pilot study of acute safety and efficacy. Bipolar Disord. 2003 Feb;5(1):40-7. doi: 10.1034/j.1399-5618.2003.00011.x.
Results Reference
background
Links:
URL
http://www.douglas.qc.ca/page/neuromodulation-program
Description
Neuromodulation Research Clinic, Douglas Mental Health University Institute

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Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression

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