The Antidepressant Effect of Right Prefrontal Low Frequency rTMS in an Accelerated Treatment Model

NCT03868774 | Withdrawn

• 1 other identifier: ADA
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Repetitive transcranial magnetic stimulation has appeared a new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the prefrontal cortex of the brain through a time varying magnetic field. The method is associated with minimal side effects limited to local discomfort and especially no impact on cognitive function. The method has been approved for the treatment of depression in Canada, USA and a couple of European countries. The department for Affective Disorders, Aarhus University Hospital has used rTMS as add-on to conventional antidepressant treatment in the outpatient clinic since 2015. A single treatment course covers 20 sessions given on 20 consecutive days. The demand for daily treatment and attendance for 20 days is resource demanding for both the patient and the clinic. In consequence the investigators want to examine the antidepressant effect of an accelerated stimulus model comparing the outcome of the standard model ( 20 days) with a treatment model covering the same number of stimuli given within one week.

Conditions

Depression

Keywords

treatment

Outcome Measures

Primary Outcomes (1)

• The Hamilton 17 item scale score for depression

  A semistructured interview. On the basis of a systematic registration of well defined depressive symptoms through the preceding 3 days a total 17 item score and af 6-item subscale score expressing the degree of depression is calculated. The score is positively correlated to the degree af depression, Remission is defined as a total score after termination of treatment of \>= 8, response is defined by \>= 50% decrease in the total 17 item score during the treatment period

  up to 4 weeks

Secondary Outcomes (1)

• cognitive function

  1 and 4 weeks

Study Arms (2)

rTMS standard

ACTIVE COMPARATOR

Low frequency (1 Hz), rTMS 20 sessions given on 20 consecutive days ( except weekends)

Procedure: repetitive transcranial magnetic stimulation

rTMS accelerated model

ACTIVE COMPARATOR

Low frequency ( 1 Hz), right prefrontal transcranial magnetic stimulation. 20 sessions given on 5 consecutive days ( 4 sessions each day)

Procedure: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation PROCEDURE

rTMS is a new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the prefrontal cortex of the brain through a time varying magnetic field.

rTMS accelerated model; rTMS standard

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate-severe uni- and bipolar depression according to the International Classification of Diseases (ICD-10)
• A Hamilton scale score (HDS-17) of ≥ 18 and/or a sub-scale (HDSS) score of ≥ 9 within 24-48 hours before the first treatment

You may not qualify if:

• Organic brain disease.
• Epileptic seizure \< 2 years
• Patients with implanted metal parts in the brain or chest
• Patients with pacemaker
• Medical diseases with cerebral impact
• Serious suicidal danger

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Poul Erik Buchholtz, MD

  Department of Depression and Anxiety

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Project collaborators examining the degree of depression during intervention are blinded to the type of treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior researcher

Model Details: comparing the antidepressant effect of a standard rTMS model with an accelerated treatment model

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 11, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share