Condition category
Mental and Behavioural Disorders
Date applied
01/08/2014
Date assigned
18/08/2014
Last edited
18/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
High frequency repetitive transcranial magnetic stimulation (HF-rTMS) is a form of brain stimulation therapy that is often used, for example, to treat depression when other treatments have not worked (that is, treatment resistant depression). It involves using magnetic pulses to stimulate a part of the brain that controls mood. This causes an electric current to be passed to specific nerve (brain) cells. The therapy is believed to work by resetting brain wave frequencies to normal and therefore relieving the symptoms of depression. In this study, we are investigating how successful two sessions of HF-rTMS is in treating patients with treatment resistant depression compared to only one HF-rTMS session or either one or two sham (dummy) sessions. The results should help us to develop faster and more successful treatment for patients with treatment resistant depression.

Who can participate?
Adults aged 18-59 years, who are right handed, have treatment resistant depression and have not had HF-rTMS therapy before.

What does the study involve?
Participants are randomly allocated into one or 4 groups. Those in group 1 receive three weeks of treatment of two HF-rTMS sessions per day, group 2 recieve one HF-rTMS session per day, group 3 receive two sham sessions a day and group 4 receive one sham session per day. Each participant has a follow up session 2 weeks after the treatment.

What are the possible benefits and risks of participating?
Participants that receive HF-rTMS sessions might find that their depression symptoms are alleviated, particularly those in the two session a day group. Patients who have HF-rTMS therapy usually experience some slight pain or discomfort at the site of stimulation. Seizures can occur if specific safety guidelines are not followed, but this is very rare.

Where is the study run from?
First Department of Psychiatry, Eginition Hospital, National and Kapodistrian University of Athens, Athens (Greece).

When is the study starting and how long is it expected to run for?
July 2006 to December 2011

Who is funding the study?
The First Department of Psychiatry, Eginition Hospital, National and Kapodistrian University of Athens, Athens (Greece).

Who is the main contact?
Christos Theleritis
chtheler@med.uoa.gr or ctheleritis@gmail.com

Trial website

http://www.eginitio.gr/Erevna/

Contact information

Type

Scientific

Primary contact

Prof Pavlos Sakkas

ORCID ID

Contact details

72-74 Vas. Sofias Avenue
Athens
11528
Greece
+30 (0) 2107289324
psakkas@med.uoa.gr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0527821514 1st Psychiatric Dept, Eginition University Hospital, National and Kapodistrian University of Athens, Athens, Greece

Study information

Scientific title

Two vs. one high-frequency rTMS session per day for treatment-resistant depression: a randomized sham-controlled trial.

Acronym

Study hypothesis

High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has proven antidepressant effects, but the optimal frequency of sessions remains unclear. It is hypothesised that twice per day HF-rTMS sessions will be more effective than once per day session in patients with treatment resistant depression (TRD). The null hypothesis is that there will be no difference between once and twice per day sessions of HF-rTMS.

Ethics approval

First Department of Psychiatry Ethics Committee, Eginition University Hospital,02/05/2006, ref. 0527821514.

Study design

5-year parallel-group, randomized, sham-controlled one-site trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Depression

Intervention

We conducted a 3-week, sham- controlled trial to assess the antidepressant efficacy of one session/day compared to two active rTMS sessions/ day (A2 group) and equivalent sham sessions once/day and twice/ day in 98 patients with treatment-resistant major depression (TRD), with a subsequent 2-week follow-up period.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Difference from baseline in Hamilton Depression Rating Scale (HDRS) score and Clinician Global Impressions-Severity of Illness (CGI-S) score at the end of treatment and follow-up.

Secondary outcome measures

None

Overall trial start date

01/07/2006

Overall trial end date

01/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Meet DSM-IV-TR criteria for current non-psychotic major depressive disorder
2. Have treatment resistant depression (with failure of at least two trials of two different antidepressants)
3. 18-59 years of age
4. Right handed
5. Be naïve to TMS

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

98

Participant exclusion criteria

1. History of seizures
2. History of head injury with loss of consciousness
3. History of brain surgery
4. History of presence of metallic implants
5. History of dementia or other Axis I diagnosis
6. History of substance dependence or abuse within the previous 6 months
7. Pregnancy

Recruitment start date

01/07/2006

Recruitment end date

01/12/2011

Locations

Countries of recruitment

Greece

Trial participating centre

72-74 Vas. Sofias Avenue
Athens
11528
Greece

Sponsor information

Organisation

First Psychiatry Dept., Eginition Hospital, National and Kapodistrian University of Athens (Greece)

Sponsor details

72-74 Vas. Sofias Avenue
Athens
11528
Greece
+30 (0) 2107289324
egslelabath@hol.gr

Sponsor type

Hospital/treatment centre

Website

http://www.eginitio.gr/

Funders

Funder type

Hospital/treatment centre

Funder name

First Department of Psychiatry, Eginition Hospital, National and Kapodistrian University of Athens (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes