NCT00822601

Brief Summary

Our study's purpose is to show the efficacy of the transcranial magnetic stimulation (a non invasive method of cerebral modulation) in patients suffering from chronic obsessive compulsive disorder (OCD). This new method will be applied in 20 patients during 4 weeks (5 sessions each week), and its effects on OCD symptoms will be compared to those of a "sham" (=placebo) stimulation applied with the same process in 20 other patients, randomly assigned to the comparison group. The maintenance of the therapeutic effects will be explored during 8 weeks following the end of the treatment. In addition to classical scales used to measure the treatment effects, all patients will be examined using a functional magnetic resonance imaging (fMRI) before and after treatment to explore the cerebral effects of rTMS

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 31, 2012

Status Verified

January 1, 2009

Enrollment Period

3.4 years

First QC Date

January 13, 2009

Last Update Submit

July 30, 2012

Conditions

Obsessive-Compulsive Disorder

Keywords

Repetitive Transcranial Magnetic StimulationSupplementary Motor AreaObsessive-Compulsive DisorderSham rTMSPlacebo-controlledRandomizedDouble-blindfMRIDSM-IV Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • Yale-Brown Obsessive Compulsive Scale (YBOCS)

    week 1, 2, 3, 4, 5, 7, 9, 11, 13

Secondary Outcomes (9)

  • Clinical Global Impression - Severity (CGI-S)

    week 1, 2, 3, 4, 5, 7, 9, 11, 13

  • - Clinical Global Impression - Improvement (CGI-I)

    week 1, 2, 3, 4, 5, 7, 9, 11, 13

  • Global Assessment of Functioning (GAF)

    week 5, 13

  • - Montgomery Asberg Depression Rating Scale (MADRS)

    week 5, 13

  • Brief Anxiety Scale (BAS

    week 5, 13

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Device: rTMS

2

PLACEBO COMPARATOR
Device: Sham Comparator

Interventions

rTMSDEVICE

Arm 1 (experimental) : rTMS, 4 weeks of stimulation with RMT frequency 1Hz, intensity 100% of RMT for 20 minutes (1500 pulses), 5 minutes of trains with 2 minutes of intra-train intervals to both SMA. Treatment will be given 5 times a week for 4 weeks.

1
Sham ComparatorDEVICE

sham rTMS (using a placebo coil), 4 weeks of stimulation, will mimic the active treatment mentioned above.

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed patient informed consent;
  • primary obsessive compulsive disorder;
  • current YBOCS score at least 15 with or without drug (or obsessive/compulsive subscores of at least 10);
  • males/females 18-65yrs;
  • treated with at least two adequate dose of SRI at least 8 weeks at some stage of illness;
  • currently using adequate, stable dose of SSRI at least 8 weeks but not responding.

You may not qualify if:

  • schizophrenia, other psychotic disorders, bipolar I, current major depressive disorder (MADRS\>20), substance/alcohol dependence within last 6 months;
  • severe axis II;
  • significant suicide risk;
  • metallic implant in cranium;
  • severe/unstable medical conditions;
  • ECT in the last month;
  • pregnancy or breastfeeding ;
  • history epilepsy; neurological disorder leading to increased intracranial pressure; severe cardiac disorder/intracardiac lines, pacemakers; Gilles de la Tourette syndrome;
  • current structured psychotherapy;
  • current drug treatment of bipolar disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitie Salpetriere Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Antoine Pelissolo, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

November 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 31, 2012

Record last verified: 2009-01

Locations

FR(1)