Efficacy of Intermittent ThetaBurst Stimulation Compared to 10 Hz Stimulation on Dorsolateral Prefrontal Cortex in Treatment Resistant Major Depressive Disorder: a Double-blind Randomized Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02376491

Acronym

THETA-DEP

Enrollment

Registered

2015-03-03

Start date

2015-06-30

Completion date

2019-03-31

Last updated

2019-07-05

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

Conditions

DEPRESSION

Brief summary

This trial will compare innovating stimulation parameters, intermittent Theta Burst Stimulation, to the standard high frequency stimulation protocol. The Left dorsolateral prefrontal cortex, targeted by MRI navigation will be the site of stimulation in both treatment conditions. The study seeks to determine if there is a superiority in therapeutic efficacy with iTBS protocol compared to conventional one.

Interventions

DEVICETranscranial magnetic stimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Age 18 years to 75 years * Both gender eligible * Volontary and able to give consent * Major depressive episode (MADRS \> 20) single or recurrent * Resistance to at least 2 antidepressants , * Treated by antidepressant at efficient stable posology since more than 6 weeks

Exclusion criteria

* Initiation or modification of antidepressant drug * Neurodegenerative diseas * Bipolar I, II disorder * Schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms * Substance abuse in past 15 days * Substance dependence not weaned * Benzodiazepine and any anticonvulsant during rTMS treatment course * ECT failure in medical history * Contra-indication to rTMS and MRI * Pregnancy * Difficulty to obtain informed consent

Design outcomes

Primary

Measure	Time frame	Description
Therapeutic response rate	6 months	Primary outcome will be therapeutic response rate corresponding to with MADRS score improvement \> 50 % in each group at the end of TMS sessions and one month after. A final score of \<8 is categorized as remission.

Secondary

Measure	Time frame
Relapse rate	6 months
Quality of life	6 months
Measures of cortical excitability	6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026