Depressive Disorder, MajorDESTIMCARENCT03436823
Does Nurse Semi Structured Interview Added to a rTMS Improve Patients With Major Depressive Disorder?
A study testing nurse semi-structured interview and Music & Relaxation with eyes closed in people with Depressive Disorder, Major, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- nurse semi-structured interview and Music & Relaxation with eyes closed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2018to 6 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Depressive Disorder, Major
- Being tested
- nurse semi-structured interview, Music & Relaxation with eyes closed
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse semi-structured interviewOther
The first session of rTMS is D1. From the first meeting to D14 semi -structured interviews are set up
Music & Relaxation with eyes closedOther
The first session of rTMS is D1. From the first meeting to D14 music \& relaxation with eyes closed sessions are set up
| Study group | Role | What they receive |
|---|---|---|
| R.TMS + nurse semi-structured interview | Experimental | Repeated Transcranial Magnetic Stimulation sessions associated with nurse semi-structured interview Receives: Other: nurse semi-structured interview |
| R.TMS + Music & Relaxation | Sham comparator | Repeated Transcranial Magnetic Stimulation sessions associated with music listening \& relaxation with eyes closed Receives: Other: Music & Relaxation with eyes closed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start19 Mar 2018
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Dominique Drapier, MD, Principal investigator, Centre Hospitalier Guillaume Régnier,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436823
- Sponsor's protocol ID
- 35RC14_9783_DESTIMCARE
- Acronym
- DESTIMCARE
- Status last verified
- Jan 2023
- First submitted
- 12 Feb 2018
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03436823
- Acronym / sponsor ID
- DESTIMCARE / 35RC14_9783_DESTIMCARE
- Conditions
- Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R.TMS + nurse semi-structured interview | Experimental | Other: nurse semi-structured interviewRepeated Transcranial Magnetic Stimulation sessions associated with nurse semi-structured interview |
| R.TMS + Music & Relaxation | Sham comparator | Other: Music & Relaxation with eyes closedRepeated Transcranial Magnetic Stimulation sessions associated with music listening \& relaxation with eyes closed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse semi-structured interviewThe first session of rTMS is D1. From the first meeting to D14 semi -structured interviews are set up | Other | R.TMS + nurse semi-structured interview |
| Music & Relaxation with eyes closedThe first session of rTMS is D1. From the first meeting to D14 music \& relaxation with eyes closed sessions are set up | Other | R.TMS + Music & Relaxation |
Primary outcome
score of the Montgomery-Asberg Depression Rating Scale
Time frame: day 44
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Drapier, MD principal investigator
Centre Hospitalier Guillaume Régnier,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse semi-structured interview and Music & Relaxation with eyes closed in people with Depressive Disorder, Major, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of the Montgomery-Asberg Depression Rating Scale (time frame: day 44). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.