Depressive Disorder, Major Clinical Trial
— DESTIMCAREOfficial title:
Does Nurse Semi - Structured Interview Added to a Repeated Transcranial Magnetic Stimulation Improve Patients With Major Depressive Disorder? A Single Center Study, Randomized, Controlled and Single Blind
Verified date | January 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | CHGR | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Ministry of Health, France |
France,
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 |
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 |