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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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repetitive transcranial magnetic stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Repetitive Transcranial Magnetic Stimulation

Sham comparator

Placebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks

Group Type SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Repetitive Transcranial Magnetic Stimulation

Interventions

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Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Other Intervention Names

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TMS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No