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Completed

NCT Number: NCT04259554

OFC rTMS in Emotionally Unstable and Depressed Patients

Treatment of depression with conventional transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. Recently, it could be demonstrated that treatment of the right orbitofrontal cortex may be effective in patients who did not respond to conventional DLPFC rTMS. Orbitofrontal cortex (OFC) seem to be involved in the etiopathology of emotionally instable personality disorders. Thus, the present one-arm trial is a pilot study investigating if OFC rTMS is feasable, tolerable and effective.

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Key information

Conditions

Personality Disorder, Borderline Behavior Behavioral Symptoms Borderline Personality Disorder Depression Mental Disorders Personality Disorder; Unstable Personality Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regensburg

Regensburg, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ICD-10: F60.30 or F60.31
  • depressive symptoms and HAMD-21 score of at least 7
  • sex: female and male
  • residence in Germany and German speaking
  • written informed consent

Exclusion criteria

  • meeting the contraindications for transcranial magnetic stimulation (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump)
  • neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma)
  • participation in another study parallel to the Trial
  • other mental or somatic illness which is not compatible with participation according to the principal investigator
  • pregnancy or breastfeeding period
  • psychiatric confinement

Treatment and study plan

OFC rTMS

Device

repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)

Primary outcomes

  1. Hamilton depression rating scale (HDRS)

    Time frame: 4 weeks

    measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores

Secondary outcomes

  1. Major Depression Inventory (MDI)

    Time frame: 2 weeks, 4 weeks, 12 weeks

    measurment of depressivity: 10 items with a range 0-50 and higher values indicating higher scores

  2. Clinical global impression (CGI)

    Time frame: 2 weeks, 4 weeks, 12 weeks

    measure of overall symptom severity and treatment response on a scale 1-7 with higher scores presenting more symptoms

  3. Depression module of the Patient health questionnaire (PHQ-D)

    Time frame: 4 weeks, 12 weeks

    measurment of depressivity: 9 items with a range 0-27 and higher values indicating higher scores

  4. Barratt impulsiveness Scale (BIS)

    Time frame: 4 weeks, 12 weeks

    measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores

  5. Numeric rating scale of pain

    Time frame: 2 weeks, 4 weeks

    Numeric rating scale of pain (the higher the score the higher the pain) with a range 0-10

  6. nicotine use

    Time frame: 2 weeks, 4 weeks, 12 weeks

    number of smoked cigarettes per day (the higher the value the higher the use)

  7. Hamilton depression rating scale (HDRS)

    Time frame: 2 weeks, 4 weeks, 12 weeks

    measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores

  8. Borderline Symptom List (BSL-23)

    Time frame: 2 weeks, 4 weeks, 12 weeks

    measurment of symptoms of borderline personality disorder: 23 items with a range 0-92 and higher values indicating higher scores

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Orbitofrontal Cortex Transcranial Magnetic Stimulation in Patients With Emotionally Unstable Personality Disorder and Depression

Acronym: ORIENT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2020
Registry last updated
Dec 9, 2022

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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