Patients With Resistant Depressive Disorders Clinical Trial
— rTMSOfficial title:
Monocentric Pilot Study, for a Randomized, Crossover, Blinded Trial: Comparison of the Therapeutic Efficacy of Low Frequency Repeated Transcranial Magnetic Stimulation on Cortical Area 9 Compared to Brodmann Area 46 in the Treatment of Depressive Disorders.
| Verified date | August 2018 |
| Source | Centre Hospitalier Universitaire Dijon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Repetitive transcranial magnetic stimulation (rTMS) is a new therapeutic tool used in
psychiatry. Non-invasive, well tolerated and requiring no premedication, it is performed on
an outpatient basis. The principle of this technique is to stimulate the cerebral cortex from
an electromagnetic coil placed on the scalp. Unlike electroconvulsive therapy, rTMS induces
an electrical current on a well-defined region of the cerebral cortex.
In psychiatry, this technique is mainly considered in the treatment of depressive disorders
resistant to antidepressant medication. The brain target, obtained from brain imaging data in
depressed patients, is the dorsolateral prefrontal cortex (DLPFC). The Food and Drug
Administration (FDA) has recognized the interest of rTMS for treating depressive disorders
(October 7, 2008).
However, some stimulation parameters still need to be optimized before rTMS can be considered
a therapeutic method in its own right and used routinely. Indeed, its effectiveness over time
has not yet been evaluated, and rTMS has shown a lack of reproducibility between subjects
[Foucher, 2007]. Finally, the therapeutic results of rTMS are very modest whatever the study
[Daskalakis, 2008]. Additional studies are therefore needed to optimize stimulation
parameters.
| Status | Completed |
| Enrollment | 17 |
| Est. completion date | October 2013 |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: Patients with resistant depressive disorders (Hamilton-17-item scale > 22, failure = 2 antidepressants) with at least one of the following criteria : - venlafaxine treatment failure (unlike the national PHRC, patients who receive/have received venlafaxine treatment for the current depressive episode are included), - therapeutic failure in PHRC national rTMS 2007, - refusal to participate in the PHRC national rTMS 2007. Exclusion Criteria: - Bipolar disorders: type I or II, - Depression with psychotic characteristics, - Schizophrenia, - Risky or harmful use of alcohol and/or an illicit psychoactive substance, - Dependence on alcohol and/or an illicit psychoactive substance, - Sick and hospitalized under duress or under legal protection (guardianship, curatorship), - Contraindication to the practice of rTMS; personal history of seizures, history of neurological or neurosurgical pathologies, metallic prosthetic materials or foreign bodies (pacemaker, etc...), - Contraindication to brain MRI, - Pregnancy or breastfeeding in progress - Resistance to Escitalopram |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Dijon Bourogne | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The remission rate | Compare the remission rates (decrease < 50% of the HDRS score / initial score) during neuronavigated stimulations on BA 9 and BA 46 compared to the average rate obtained during manual stimulation. | Through study completion, an average of 11 weeks. |