Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study
TMS/DEP
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 major-depressive-disorder
Started Jan 2007
Longer than P75 for phase_2 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 9, 2015
March 1, 2015
8.9 years
February 24, 2015
March 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
'Hamilton depression rating scale (HDRS)
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
Study Arms (2)
repetitive transcranial magnetic stimulation
ACTIVE COMPARATORRepetitive Transcranial Magnetic Stimulation (rTMS) Treatment 5 days/week for up to 4 weeks
Sham comparator
SHAM COMPARATORPlacebo Comparator: Placebo Treatment 5 days/week for up to 4 weeks
Interventions
Repetitive Transcranial Magnetic Stimulation
Eligibility Criteria
You may qualify if:
- TRD stage I Thase-Rush
- HDRS + or = 18
- Patients age 18 to 70 years.
- Negative pregnancy test and contraception for women.
- Informed Consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unité de Recherche Clinique
Neuilly-sur-Marne, Île-de-France Region, 93330, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rene BENADHIRA, MD
E.P.S ville Evrard
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
February 24, 2015
First Posted
March 9, 2015
Study Start
January 1, 2007
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 9, 2015
Record last verified: 2015-03