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Completed

NCT Number: NCT02376491

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Primary outcomes

  1. Therapeutic response rate

    Time frame: 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 outcomes

  1. Relapse rate

    Time frame: 6 months

  2. Quality of life

    Time frame: 6 months

  3. Measures of cortical excitability

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: THETA-DEP

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2015
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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