Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression

Bipolar Depression Clinical Trial

— iTBS-BIP  

Official title:

Effects of Intermittent Theta Burst Stimulation Applied Over the Left Dorsolateral Prefrontal Cortex in Patients With Treatment-resistant Bipolar Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02740244
• Other study ID #: 1018 rTMS DEP BIP
• Status: Terminated
• Phase: N/A
• Start date: January 2011
• Est. completion date: January 2015

Study information

• Verified date: July 2018
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to evaluate the evaluate the clinical interest and the safety of repetitive transcranial magnetic stimulation (rTMS) delivered as intermittent Theta burst stimulation(iTBS) on severity of depression in patients with treatment-resistant bipolar disorder.

Description:

Methods: A double-blind randomized sham-controlled pilot study will be conducted in 40 patients with bipolar treatment-resistant depression receiving either active (n=20) or sham (n=20) iTBS over the left dorsolateral prefrontal cortex.

Depression severity will be assessed by an investigator blinded to iTBS condition before and after 10 to 30 iTBS sessions depending on remission onset. Remission will be defined as Beck Depression Inventory, BDI score<10.

Objective/Hypothesis: The investigators hypothesized the superiority of active iTBS over sham ITBS

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, DSM-IV criteria

• Montgomery and Asberg depression scale > 20

Exclusion Criteria:

• other psychiatric features, rapid cycles

• Benzodiazepines intake

• pregnancy

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Device:
• active iTBS
Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a figure-eight coil (MCF-B65)
• sham iTBS
Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a sham figure-eight coil (MCF-P-B65)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory	Self-reported clinical scale with 13 items	2 time point measure, before and after the end of stimulation sessions (changes from baseline BDI scores at 6 weeks)