ORIENT: OFC rTMS in Emotionally Unstable and Depressed Patients

• Sponsor: University of Regensburg (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04259554
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 19.5
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Personality Disorder, Borderline; Personality Disorder; Unstable; Depression	Device: OFC rTMS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Orbitofrontal Cortex Transcranial Magnetic Stimulation in Patients With Emotionally Unstable Personality Disorder and Depression
• Actual Study Start Date: Feb 14, 2020
• Anticipated Primary Completion Date: Jun 30, 2021
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OFC rTMS repetitive transcranial magnetic stimulation	Device: OFC rTMS; repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)

Outcome Measures

Primary Outcome Measures

1. Hamilton depression rating scale (HDRS) [4 weeks]

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

Secondary Outcome Measures

1. Major Depression Inventory (MDI) [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) [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) [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) [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 [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 [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) [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) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Regensburg	Regensburg		Germany

Sponsors and Collaborators

• University of Regensburg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Berthold Langguth, MD, Ph.D., Clinical Professor, University of Regensburg
• ClinicalTrials.gov Identifier: NCT04259554
• Other Study ID Numbers: 19-1615-101
• First Posted: Feb 6, 2020
• Last Update Posted: Jan 20, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Berthold Langguth, MD, Ph.D., Clinical Professor, University of Regensburg: rTMS
• Additional relevant MeSH terms: Disease; Depression; Personality Disorders; Borderline Personality Disorder

Study Results

No Results Posted as of Jan 20, 2021