Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study (TMS/DEP)

March 3, 2015 updated by: René BENADHIRA, Centre hospitalier de Ville-Evrard, France

number of center : 1

  • duration of study : 24 months
  • recruitement time : 23 months
  • Aim :Principal

Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients.

Secondary

Evaluate the impact of rTMS on cognitive functions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study involves 40 TRD patients in a single site trial which consisted of two phases: an acute phase (phase I) in which all the participants receive active high-frequency stimulation during 4 blocks of five consecutive working days (Monday to Friday) in an open-label design and a maintenance phase (phase II) in which responders (> 49% HDRS-17 reduction from baseline) at the end of the phase I are randomized in two arms with sham or active high-frequency rTMS maintenance treatment for the eleven following months. The rhythm of rTMS sessions in this maintenance phase is gradually reduced as follows: 3 sessions per week for 2 weeks, 2 session per week for the 2 following weeks, 1 session per week the third (M3) and fourth month (M4) and then 1 session every fortnight the last eight months (M5 to M12).

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Île de France
      • Neuilly Sur Marne, Île de France, France, 93330
        • Recruiting
        • Unite de Recherche Clinique
        • Contact:
          • Arezki OURRAD, BIOLOGISTE
          • Phone Number: 0143093232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • TRD stage I Thase-Rush
  • HDRS + or = 18
  • Patients age 18 to 70 years.
  • Negative pregnancy test and contraception for women.
  • Informed Consent

Exclusion Criteria:

  • Patient was treated with mood stabilizer in the previous week
  • Other disorder on axis I of the DSM IV than depressive disorder.
  • Patient with an addiction problem other than tobacco and caféine
  • antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker
  • Previous history of head trauma the previous two years.
  • intracranial hypertension.
  • not affiliated to the social security Patient
  • patient under constraint hospitalisation
  • Under legal protection measure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: repetitive transcranial magnetic stimulation
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks
Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation
Other Names:
  • TMS
Sham Comparator: Sham comparator
Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks
Device: Repetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation
Other Names:
  • TMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
'Hamilton depression rating scale (HDRS)
Time Frame: one years

The efficacy variables included the HDRS-17 item scores, the CGI changes, the Visual Analog Scale (VAS), the Beck Depression Inventory (BDI) and the Hospital Anxiety Depression (HAD).

The subjective assessment performed with the VAS consisted of a 100-mm horizontal line oriented with anchors placed at both poles for reassured, sadness, anxiety, and relief. The patients are asked to mark a spot along this line that best indicated the magnitude of their state for each item.
one years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de Ville-Evrard, France

Investigators

  • Principal Investigator: Rene BENADHIRA, MD, E.P.S ville Evrard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-A00244-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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