Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03436823
Other study ID # 35RC14_9783_DESTIMCARE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 19, 2018
Est. completion date January 6, 2023

Study information

Verified date January 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Repeated Transcranial Magnetic Stimulation - R.TMS - is currently part of the treatment for depressive illness. This non-invasive technique is designed to stimulate certain areas of the cerebral cortex involved in this pathology. FDA approved this treatment in routine for depressive illness. R.TMS still remains in assessment. Due to the heterogeneity of methods and the weakness of the cohorts therapeutic superiority can not concluded . Stimulation parameters remain numerous even if a consensus is beginning to emerge. The therapeutic target is the left dorso - lateral prefrontal cortex. The lack of efficacy is probably due of the inaccuracy. The empirically location of the target does not take into account the inter-individual anatomical differences. The neuronavigation is becoming widespread in routine clinical practice. The referent nurse stays with the patient all along the rTMS sessions. His role is to set up treatment, to ensure the safety and the well-being of the patient. An rTMS session is an average of 30 minutes and is a very special moment to create a specific therapeutic relationship. No study was conducted to evaluate the therapeutic relationship. The assumption is made that rTMS with a semi - structured interview provides a qualitative and quantitative clinical response greater than a semi - structured rTMS without this nursing care. The investigators therefore propose to patients not receiving a semi-structured interview to listen to music with eyes closed.


Description:

Repeated Transcranial Magnetic Stimulation - R.TMS - is currently part of the treatment for depressive illness. This non-invasive technique is designed to stimulate certain areas of the cerebral cortex involved in this pathology. The Food & Drug Administration - FDA - approved this treatment in routine for depressive illness. R.TMS still remains in assessment. Due to the heterogeneity of methods and the weakness of the cohorts therapeutic superiority can not concluded . Stimulation parameters remain numerous even if a consensus is beginning to emerge. The therapeutic target is the left dorso - lateral prefrontal cortex. The lack of efficacy is probably due of the inaccuracy. The empirically location of the target does not take into account the inter-individual anatomical differences. The neuronavigation is becoming widespread in routine clinical practice. The referent nurse stays with the patient all along the rTMS sessions. His role is to set up treatment, to ensure the safety and the well-being of the patient. An rTMS session is an average of 30 minutes and is a very special moment to create a specific therapeutic relationship. To our knowledge, no study was conducted to evaluate the therapeutic relationship. The assumption is made that rTMS with a semi - structured interview provides a qualitative and quantitative clinical response greater than a semi - structured rTMS without this nursing care. The investigators, therefore propose to patients not receiving a semi-structured interview to listen to music with eyes closed.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 6, 2023
Est. primary completion date January 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients volunteers aged 18 to 70, - With the diagnosis of major depression, recurrent under the criteria of DSM.V, - With an unmodified antidepressant treatment for 3 weeks, - With a MADRS score greater than or equal to 21, - With or without neuronavigated rTMS sessions, - Informed and who have signed a consent. Exclusion Criteria: - Patients with psychotic symptoms, - With alcohol dependence or other substances abuse, - With the strength criteria defined by the V stage for Classification of Thase & Rush, - Hospitalized without consent / or under legal protection for major. - With a high risk of suicide - item 10 of the MADRS> 3 in the absence of hospitalization, - With contraindications to the practice of MRI or rTMS due to previous seizures, neurological disorders and / or neurosurgical, metal prosthetic presence or foreign bodies pacemaker type intraocular ferromagnetic material, - Aged over 70 years due to cortical alteration, - Pregnancy.

Study Design


Intervention

Other:
nurse semi-structured interview
The first session of rTMS is D1. From the first meeting to D14 semi -structured interviews are set up
Music & Relaxation with eyes closed
The first session of rTMS is D1. From the first meeting to D14 music & relaxation with eyes closed sessions are set up

Locations

Country Name City State
France CHGR Rennes

Sponsors (2)

Lead Sponsor Collaborator
Rennes University Hospital Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary score of the Montgomery-Asberg Depression Rating Scale The ratings should be based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones which allow a precise rating of severity. The rater must decide whether the rating lies on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5). It is important to remember that it is only rare occasions that a depressed patient is encountered who cannot be rated on the items in the scale. If definite answers cannot be elicited from the patients, all relevant clues as well as information from other sources should be used as a basis for the rating in line with customary clinical practice. day 44
See also
  Status Clinical Trial Phase
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Completed NCT04469322 - Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05988333 - Psychoeducational Intervention for Families With a Member Affected by Major Depression N/A
Completed NCT02919501 - Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder Phase 2
Completed NCT00976560 - Clinical Study to Test a New Drug to Treat Major Depression Phase 2
Recruiting NCT05518149 - A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD) Phase 3
Not yet recruiting NCT06303076 - Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial Phase 4
Not yet recruiting NCT05901571 - Acupuncture and Escitalopram for Treating Major Depression Clinical Study N/A
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Suspended NCT02546024 - Predictors of Treatment Response in Late-onset Major Depressive Disorder N/A
Completed NCT01583400 - Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial N/A
Completed NCT01407575 - Buprenorphine for Treatment Resistant Depression Phase 3
Completed NCT01152996 - Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study Phase 3
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository
Completed NCT00384033 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder Phase 3
Completed NCT00369343 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women Phase 3
Completed NCT00366652 - Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects Phase 3
Completed NCT00149643 - Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence Phase 2
Completed NCT00316160 - Sexual Functioning Study With Antidepressants Phase 4