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Bipolar DepressionPhase 2/3NCT01586793

Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression

A Phase 2/3 study testing Magstim Rapid2 Stimulator in people with Bipolar Depression, run by Douglas Mental Health University Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Bipolar Depression
What is being tested?
Magstim Rapid2 Stimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteCanada
Study dates
May 2012to Jan 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Neuromodulation Research Clinic, Douglas Mental Health University Institute

    Verdun, Quebec, H4H1R3

Other trials in Canada

About this study

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

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.

Being tested
Magstim Rapid2 Stimulator
Keywords
Repetitive transcranial magnetic stimulation, Bipolar depression, Randomized trial, rTMS, Neuromodulation
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magstim Rapid2 StimulatorDevice

    Also called 1 Hz rTMS

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

  • Magstim Rapid2 StimulatorDevice

    Also called 10 Hz rTMS

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

Study groups in NCT01586793
Study groupRoleWhat they receive
High Frequency rTMSExperimental10 Hz in 75 trains of 4-seconds duration, with 26-seconds intertrain intervals (3,000 pulses per session) at 120% of the rMT.
Receives: Device: Magstim Rapid2 Stimulator
Low Frequency rTMSExperimental1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT.
Receives: Device: Magstim Rapid2 Stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montgomery-Asberg Depression Rating Scale (MADRS)

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

    Measured: Week 5

Secondary outcomes (4)

  1. 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.

    Measured: Week 5

  2. 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.

    Measured: Week 5

  3. 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.

    Measured: Week 5

  4. 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.

    Measured: Week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01586793
Sponsor's protocol ID
rTMS-ERB12/05-2012
Status last verified
May 2015
First submitted
24 Apr 2012
Last updated
28 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19133969

  • 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.

    PubMed 12479689

  • 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.

    PubMed 12656937

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Magstim Rapid2 Stimulator in people with Bipolar Depression, run by Douglas Mental Health University Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Week 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01586793, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.

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