The Antidepressive Effect of rTMS as add-on to ECT

NCT02123485 | Terminated Results DMC

• 1 other identifier: 1-10-72-509-12
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to investigate in which degree low frequency right prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate remission . To investigate the correlation between blood concentration of specific inflammation makers and change in depressive symptoms during treatment

Conditions

Depression

Keywords

Depression,; ECT,; rTMS,; Right prefrontal,; antidepressive efficacy

Outcome Measures

Primary Outcomes (1)

• Remission

  The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcomeRemission is defined by a Hamilton 17-item total score \< 8.

  7 weeks

Secondary Outcomes (1)

• Response

  7 weeks

Study Arms (2)

low frequency rTMS

EXPERIMENTAL

Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week

Device: Low frequency (1 hz) rTMS, as add-on to ECT

Sham-rTMS

SHAM COMPARATOR

Sham right prefrontal rTMS 2 times a week

Device: Sham-rTMS

Interventions

Low frequency (1 hz) rTMS, as add-on to ECT DEVICE

Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT.

low frequency rTMS

Sham-rTMS DEVICE

Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.

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:

• Patients admitted to the Psychiatric Hospital of Aarhus
• Patients referred for ECT
• Age 18-80 years
• Moderate or severely depressed patients (ICD-10(DSM-IV)
• HAM-D score (17-item) ≥20 and/or Ham-D subscale ≥10.

You may not qualify if:

• Organic brain disease
• Epilepsy or disposition to epilepsy
• Metallic objects in chest or brain
• Cardiac pacemaker
• Somatic diseases associated with brain dysfunction
• Pregnancy
• Severe agitation or delirium
• Alcohol or drug dependence (ICD-10)
• Use of coercive measures
• The patient does not wish to participate

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital, Risskov

Aarhus, Risskov, 8240, Denmark

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

The study is under-powered

Results Point of Contact

• Title: Dr Poul Erik Buchholtz
• Organization: Department of Affective Disorder, Aarhus University Hospital, Denmark

Buchholtz.Hansen@ps.rm.dk

21474299

Study Officials

• Poul Erik Buchholtz, MD

  Poul Erik Buchholtz, MD Telephone: 004578472109 Email: poulhans@rm.dk

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: April 25, 2014
• Study Start: April 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: February 23, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)