Clinical trial NCT02863380: Personalized rTMS for Resistant Depression
Official title: Validation of Personalized Antidepressant Treatment by Neuromodulation - Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depressive Disorder
Treatment-Resistant
Keywords: Individualized Medicine
Transcranial Magnetic Stimulation, Repetitive
Transcranial Direct Current Stimulation Monocentric
Compariative Cross-Over 3 Arms Study Randomized, Single-Blind Method
Functional Neuroimaging
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that personalizing the rTMS targets using functional MRI will increase its efficacy. The most dysfunctional regions or the most dysfunctional network will be stimulated homogeneously. Individualized rTMS will be compared to traditional rTMS procedure and to trans-cranial direct current stimulation (tDCS) in a randomized cross-over trial.

In this pilot study the primary outcome measure will be the correction of the MRI anomalies. Symptoms reduction and the proportion of remitters will be secondary outcome measurements.


Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 65 Y
* Affiliated to the health insurance
* Having signed an informed consent
* Suffering from major depression according to the DSM5
* Unresponsive or incomplete remission after at least one trial of antidepressant (\> 6 weeks at efficient dose or side effects)
* Treatment stable for \> 6 weeks

Exclusion Criteria:

* Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
* Pregnancy
* Severe and non-stabilized somatic pathology
* Patients deprived of liberty or hospitalized without their consent

Primary outcomes:
measure: Change of rCBF anomalies
timeFrame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
measure: Change of the functional connectivity anomalies
timeFrame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol)
Secondary outcomes:
measure: Change in symptoms evaluated by the clinician (QIDS16-C)
timeFrame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
measure: Change in symptoms evaluated by the patient (QIDS30-SR)
timeFrame: Difference between before (assessed once between D-7 to -1) and after (assessed once between D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
Other outcomes:
measure: Daily visual analogical scales assessing the core symptoms
timeFrame: Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
measure: Response time and accuracy at the attentional network test
timeFrame: Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
measure: Quality of life ("Echele synoptique des 3 temps")
timeFrame: Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
measure: Global Assessment of Functioning
timeFrame: Difference between before (D-7 to -1) and after (D+15 to +21) each therapeutic protocol (D = day of the beginning of the protocol).
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie 1, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Jack FOUCHER, MD
role: PRINCIPAL_INVESTIGATOR
References: