Effect of Intermittent ThetaBurst Stimulation in Treatment-resistant Bipolar Depression

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02740244

Acronym

iTBS-BIP

Enrollment

Registered

2016-04-15

Start date

2011-01-31

Completion date

2015-01-31

Last updated

2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Depression

Brief 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.

Detailed 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

Interventions

DEVICEactive iTBS

Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a figure-eight coil (MCF-B65)

DEVICEsham iTBS

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026