Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression

Douglas Mental Health University Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bipolar Depression

Treatments: Device: Magstim Rapid2 Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT01586793

rTMS-ERB12/05-2012

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

8 participants in 2 patient groups

High Frequency rTMS

Experimental group

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.

Treatment:

Device: Magstim Rapid2 Stimulator

Device: Magstim Rapid2 Stimulator

Low Frequency rTMS

Experimental group

Description:

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

Treatment:

Device: Magstim Rapid2 Stimulator

Device: Magstim Rapid2 Stimulator