Two vs. one high-frequency rTMS session per day for treatment-resistant depression

ISRCTN	ISRCTN71929667
DOI	https://doi.org/10.1186/ISRCTN71929667
Secondary identifying numbers	0527821514 1st Psychiatric Dept, Eginition University Hospital, National and Kapodistrian University of Athens, Athens, Greece

Submission date: 01/08/2014
Registration date: 18/08/2014
Last edited: 09/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Study website

Contact information

Prof Pavlos Sakkas
Scientific

72-74 Vas. Sofias Avenue
Athens
11528
Greece

Phone	+30 (0) 2107289324
Email	psakkas@med.uoa.gr

Study information

Study design	5-year parallel-group, randomized, sham-controlled one-site trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Two vs. one high-frequency rTMS session per day for treatment-resistant depression: a randomized sham-controlled trial.
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(s)	First Department of Psychiatry Ethics Committee, Eginition University Hospital,02/05/2006, ref. 0527821514.
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
Primary outcome measure	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 study start date	01/07/2006
Overall study end date	01/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	59 Years
Sex	Both
Target number of participants	98
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 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

Study participating centre

72-74 Vas. Sofias Avenue

Athens
11528
Greece

Sponsor information

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

72-74 Vas. Sofias Avenue
Athens
11528
Greece

Phone	+30 (0) 2107289324
Email	egslelabath@hol.gr
Website	http://www.eginitio.gr/
"ROR"	https://ror.org/04gnjpq42

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2017		Yes	No