Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High Frequency 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.

Group Type EXPERIMENTAL

Magstim Rapid2 Stimulator

Intervention Type DEVICE

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

Low Frequency rTMS

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

Group Type EXPERIMENTAL

Magstim Rapid2 Stimulator

Intervention Type DEVICE

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

Interventions

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Magstim Rapid2 Stimulator

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

Intervention Type DEVICE

Magstim Rapid2 Stimulator

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

Intervention Type DEVICE

Other Intervention Names

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1 Hz rTMS 10 Hz rTMS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No