The Antidepressant Efficacy of Low Frequency rTMS as add-on

NCT02966106 | Withdrawn

• 1 other identifier: AMB-TMS-16
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

rTMS has appeared a potential new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the brain through a time varying magnetic field. ). Research on rTMS reports of minimal side effects of the method . The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex . Fewer studies have used right prefrontal, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation .Both stimulus models has been shown to have statistically significant antidepressant effect and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex i associated with an antidepressant effect at the same level as the high frequency model. Therefore the investigators want to examine the antidepressant effect of a specific rTMS low frequency model in a clinical setting using a placebo controlled, randomized double blind design.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• remission

  the number of patients obtaining a Hamilton-17 item total score of \< 8

  8 weeks

Secondary Outcomes (2)

• Response

  8 weeks

• Cognitive function

  8 weeks

Study Arms (2)

Right prefrontal low frequency rTMS.

ACTIVE COMPARATOR

Right prefrontal low frequency rTMS (1Hz). A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval

Device: Right prefrontal low frequency rTMS

Sham-rTMS

PLACEBO COMPARATOR

Right prefrontal rTMS sham treatment. A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval

Other: Sham-rTMS

Interventions

Right prefrontal low frequency rTMS DEVICE

A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval

Right prefrontal low frequency rTMS.

Sham-rTMS OTHER

Right prefrontal rTMS sham treatment. A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval

Sham-rTMS

Eligibility Criteria

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

You may qualify if:

• Out-patients referred to Aarhus University Hospital, Risskov
• Moderate-severe uni- and bipolar depression according to ICD-10
• Age 18-80 years

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

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Poul Erik Buchholtz, MD

  Aarhus University Hospital, Risskov

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 17, 2016
• Study Start: December 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 29, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share