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OFC rTMS in Emotionally Unstable and Depressed Patients (ORIENT)

Primary Purpose

Personality Disorder, Borderline, Personality Disorder; Unstable, Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
OFC rTMS
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Personality Disorder, Borderline focused on measuring rTMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Regensburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OFC rTMS

Arm Description

repetitive transcranial magnetic stimulation

Outcomes

Primary Outcome Measures

Hamilton depression rating scale (HDRS)
measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores

Secondary Outcome Measures

Major Depression Inventory (MDI)
measurment of depressivity: 10 items with a range 0-50 and higher values indicating higher scores
Clinical global impression (CGI)
measure of overall symptom severity and treatment response on a scale 1-7 with higher scores presenting more symptoms
Depression module of the Patient health questionnaire (PHQ-D)
measurment of depressivity: 9 items with a range 0-27 and higher values indicating higher scores
Barratt impulsiveness Scale (BIS)
measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores
Numeric rating scale of pain
Numeric rating scale of pain (the higher the score the higher the pain) with a range 0-10
nicotine use
number of smoked cigarettes per day (the higher the value the higher the use)
Hamilton depression rating scale (HDRS)
measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores
Borderline Symptom List (BSL-23)
measurment of symptoms of borderline personality disorder: 23 items with a range 0-92 and higher values indicating higher scores

Full Information

First Posted
February 5, 2020
Last Updated
December 8, 2022
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT04259554
Brief Title
OFC rTMS in Emotionally Unstable and Depressed Patients
Acronym
ORIENT
Official Title
Orbitofrontal Cortex Transcranial Magnetic Stimulation in Patients With Emotionally Unstable Personality Disorder and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Personality Disorder, Borderline, Personality Disorder; Unstable, Depression
Keywords
rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OFC rTMS
Arm Type
Experimental
Arm Description
repetitive transcranial magnetic stimulation
Intervention Type
Device
Intervention Name(s)
OFC rTMS
Intervention Description
repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)
Primary Outcome Measure Information:
Title
Hamilton depression rating scale (HDRS)
Description
measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Major Depression Inventory (MDI)
Description
measurment of depressivity: 10 items with a range 0-50 and higher values indicating higher scores
Time Frame
2 weeks, 4 weeks, 12 weeks
Title
Clinical global impression (CGI)
Description
measure of overall symptom severity and treatment response on a scale 1-7 with higher scores presenting more symptoms
Time Frame
2 weeks, 4 weeks, 12 weeks
Title
Depression module of the Patient health questionnaire (PHQ-D)
Description
measurment of depressivity: 9 items with a range 0-27 and higher values indicating higher scores
Time Frame
4 weeks, 12 weeks
Title
Barratt impulsiveness Scale (BIS)
Description
measurment of impulsivity: 30 items with a range 0-120 and higher values indicating higher scores
Time Frame
4 weeks, 12 weeks
Title
Numeric rating scale of pain
Description
Numeric rating scale of pain (the higher the score the higher the pain) with a range 0-10
Time Frame
2 weeks, 4 weeks
Title
nicotine use
Description
number of smoked cigarettes per day (the higher the value the higher the use)
Time Frame
2 weeks, 4 weeks, 12 weeks
Title
Hamilton depression rating scale (HDRS)
Description
measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores
Time Frame
2 weeks, 4 weeks, 12 weeks
Title
Borderline Symptom List (BSL-23)
Description
measurment of symptoms of borderline personality disorder: 23 items with a range 0-92 and higher values indicating higher scores
Time Frame
2 weeks, 4 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Regensburg
City
Regensburg
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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OFC rTMS in Emotionally Unstable and Depressed Patients

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