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Does Nurse Semi Structured Interview Added to a rTMS Improve Patients With Major Depressive Disorder? (DESTIMCARE)

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nurse semi-structured interview
Music & Relaxation with eyes closed
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHGR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

R.TMS + nurse semi-structured interview

R.TMS + Music & Relaxation

Arm Description

Repeated Transcranial Magnetic Stimulation sessions associated with nurse semi-structured interview

Repeated Transcranial Magnetic Stimulation sessions associated with music listening & relaxation with eyes closed

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2018
Last Updated
January 19, 2023
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT03436823
Brief Title
Does Nurse Semi Structured Interview Added to a rTMS Improve Patients With Major Depressive Disorder?
Acronym
DESTIMCARE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
January 6, 2023 (Actual)
Study Completion Date
January 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R.TMS + nurse semi-structured interview
Arm Type
Experimental
Arm Description
Repeated Transcranial Magnetic Stimulation sessions associated with nurse semi-structured interview
Arm Title
R.TMS + Music & Relaxation
Arm Type
Sham Comparator
Arm Description
Repeated Transcranial Magnetic Stimulation sessions associated with music listening & relaxation with eyes closed
Intervention Type
Other
Intervention Name(s)
nurse semi-structured interview
Intervention Description
The first session of rTMS is D1. From the first meeting to D14 semi -structured interviews are set up
Intervention Type
Other
Intervention Name(s)
Music & Relaxation with eyes closed
Intervention Description
The first session of rTMS is D1. From the first meeting to D14 music & relaxation with eyes closed sessions are set up
Primary Outcome Measure Information:
Title
score of the Montgomery-Asberg Depression Rating Scale
Description
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.
Time Frame
day 44

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Drapier, MD
Organizational Affiliation
Centre Hospitalier Guillaume Régnier,
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHGR
City
Rennes
Country
France

12. IPD Sharing Statement

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Does Nurse Semi Structured Interview Added to a rTMS Improve Patients With Major Depressive Disorder?

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