Skip to main content
OpenTrials
Completed

NCT Number: NCT01586793

Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Neuromodulation Research Clinic, Douglas Mental Health University Institute

Verdun, Quebec, H4H1R3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magstim Rapid2 Stimulator

Device

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

Other names: 1 Hz rTMS

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Week 5

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

Secondary outcomes

  1. 21-item Hamilton Depression Rating Scale (HAM-D21)

    Time frame: Week 5

    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.

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

    Time frame: Week 5

    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.

  3. Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)

    Time frame: Week 5

    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.

  4. Montogmery-Asberg Depression Rating Scale (MADRS)

    Time frame: Week 5

    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.

Sponsors and collaborators

Lead sponsor

Douglas Mental Health University Institute

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 27, 2012
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.