NCT01586793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

April 24, 2012

Last Update Submit

May 26, 2015

Conditions

Bipolar Depression

Keywords

Repetitive transcranial magnetic stimulationBipolar depressionRandomized trialrTMSNeuromodulation

Outcome Measures

Primary Outcomes (1)

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    Pre-post neuromodulation treatment reduction on the scores of the MADRS

    Week 5

Secondary Outcomes (4)

  • 21-item Hamilton Depression Rating Scale (HAM-D21)

    Week 5

  • Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)

    Week 5

  • Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)

    Week 5

  • Montogmery-Asberg Depression Rating Scale (MADRS)

    Week 5

Study Arms (2)

High Frequency rTMS

EXPERIMENTAL

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

Device: Magstim Rapid2 Stimulator

Low Frequency rTMS

EXPERIMENTAL

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

Device: Magstim Rapid2 Stimulator

Interventions

Magstim Rapid2 StimulatorDEVICE

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

Also known as: 1 Hz rTMS
Low Frequency rTMS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromodulation Research Clinic, Douglas Mental Health University Institute

Verdun, Quebec, H4H1R3, Canada

Location

Related Publications (3)

  • 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.

    PMID: 19133969BACKGROUND

  • 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.

    PMID: 12479689BACKGROUND

  • 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.

    PMID: 12656937BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Marcelo Berlim, MD, MSc

    Douglas Mental Health University Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neuromodulation Research Clinic

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 27, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

CA(1)