MAjor Depressive DisorderNCT03265340
Clinical Effect of dTMS in Major Depressive Disorder
A study testing dTMS in people with MAjor Depressive Disorder, run by Section for Affective Disorders; Northern Stockholm Psychiatry at 1 site in Sweden.
Trial summary
Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS) dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate to severe MDD without concurrent medication will be randomised to three different treatment protocols of dTMS. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- MAjor Depressive Disorder
- What is being tested?
- dTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Sep 2016
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- see above
Who cannot join
- see above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder
Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS) dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate to severe MDD without concurrent medication will be randomised to three different treatment protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.
Read the detailed description
population: inclusion criteria:
- Ongoing episode of MDD (ICD10 F32.x) according to MINI/SCID1.
- Montgomery Asberg Depression Rating Scale (MADRS) score 20-60
- TMS safe exclusion criteria:
- Bipolar disorder 2. Substance abuse 3. fluoxetine treatment last three weeks 4. Other major Central Nervous System (CNS) disorder 5. Acute medical disorders 6. previous TMS or Electro Convulsive Treatment (ECT) <2 months before inclusion ratings: MADRS at inclusion, baseline, weekly, at last visit Clinical Global Impression Severity (CGI-S) score at baseline, at last visit Global Self-Evaluation-Memory (GSE-My) at last visit Alcohol Use Disorder Identification Test (AUDIT-C) at inclusion EuroQual 5 Dimension (EQ5D) at baseline, at last visit Quick Inventory of Depressive Symptomatology Self Rating (QIDS-SR) baseline, weekly, last visit condition: Each subject is randomised to condition A, B or C of dTMS (Brainsway): half the standard protocol (10 min; A), standard protocol (20 min; B) or double standard protocol (40 min, C). 20 treatment sessions/subject. 10 subjects in each group.
Primary endpoint: MADRS at baseline - MADRS at last visit (Intention TO Treat (ITT), Last Observation Carried Forward (LOCF))
- Conditions
- MAjor Depressive Disorder
- Being tested
- dTMS
- Keywords
- Transcranial Magnetic Stimulation
- 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.
dTMSDevice
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | dTMS standard protocol 10 min session Receives: Device: dTMS |
| B | Active comparator | dTMS standard protocol 20 min session Receives: Device: dTMS |
| C | Active comparator | dTMS standard protocol 40 min session Receives: Device: dTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS) score
MADRS baseline - MADRS last visit (treatment session 20)
Measured: baseline to last visit (treatment session 20, an average of four weeks)
Secondary outcomes (6)
Clinical Global Impression Severity (CGI-S)
CGI-Sbaseline - CGI-S last visit (treatment session 20)
Measured: baseline to last visit (treatment session 20, an average of four weeks)
Montgomery Asberg Depression Rating Scale (MADRS) response
fraction of subjects with >50% decrease in MADRS
Measured: last visit (treatment session 20, an average of four weeks)
Montgomery Asberg Depression Rating Scale (MADRS) remission
fraction of subjects with MADRS <10 points
Measured: last visit (treatment session 20, an average of four weeks)
memory objective
CPRS memory item at baseline - CPRS memory item at last visit
Measured: baseline to last visit (treatment session 20, an average of four weeks)
memory subjective
GSE-my at last visit
Measured: last visit (treatment session 20, an average of four weeks)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
systematic safety evaluation and registration of side effects
Measured: baseline to last visit (treatment session 20, an average of four weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study startSep 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MAjor Depressive DisorderStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Section for Affective Disorders; Northern Stockholm Psychiatry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Lundberg, Section for Affective Disorders; Northern Stockholm Psychiatry
- Investigators
- johan lundberg, MD PhD, Principal investigator, Norra Stockholms Psykiatri and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265340
- Sponsor's protocol ID
- dTMS dos-respons studie
- Status last verified
- Mar 2019
- First submitted
- 28 Oct 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03265340
- Acronym / sponsor ID
- dTMS dos-respons studie
- Conditions
- MAjor Depressive Disorder
- Keywords
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Section for Affective Disorders; Northern Stockholm PsychiatryUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Aug 2017 (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.
Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS) dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate to severe MDD without concurrent medication will be randomised to three different treatment protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.
Detailed description
population: inclusion criteria:
- Ongoing episode of MDD (ICD10 F32.x) according to MINI/SCID1.
- Montgomery Asberg Depression Rating Scale (MADRS) score 20-60
- TMS safe exclusion criteria:
- Bipolar disorder 2. Substance abuse 3. fluoxetine treatment last three weeks 4. Other major Central Nervous System (CNS) disorder 5. Acute medical disorders 6. previous TMS or Electro Convulsive Treatment (ECT) <2 months before inclusion ratings: MADRS at inclusion, baseline, weekly, at last visit Clinical Global Impression Severity (CGI-S) score at baseline, at last visit Global Self-Evaluation-Memory (GSE-My) at last visit Alcohol Use Disorder Identification Test (AUDIT-C) at inclusion EuroQual 5 Dimension (EQ5D) at baseline, at last visit Quick Inventory of Depressive Symptomatology Self Rating (QIDS-SR) baseline, weekly, last visit condition: Each subject is randomised to condition A, B or C of dTMS (Brainsway): half the standard protocol (10 min; A), standard protocol (20 min; B) or double standard protocol (40 min, C). 20 treatment sessions/subject. 10 subjects in each group.
Primary endpoint: MADRS at baseline - MADRS at last visit (Intention TO Treat (ITT), Last Observation Carried Forward (LOCF))
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Device: dTMSdTMS standard protocol 10 min session |
| B | Active comparator | Device: dTMSdTMS standard protocol 20 min session |
| C | Active comparator | Device: dTMSdTMS standard protocol 40 min session |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- see above
Key exclusion criteria (1 listed)
- see above
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 |
|---|---|---|
| dTMS | Device | A, B, C |
Primary outcome
Montgomery Asberg Depression Rating Scale (MADRS) score
Time frame: baseline to last visit (treatment session 20, an average of four weeks)
MADRS baseline - MADRS last visit (treatment session 20)
6 secondary outcomes
Clinical Global Impression Severity (CGI-S)
Time frame: baseline to last visit (treatment session 20, an average of four weeks)
Montgomery Asberg Depression Rating Scale (MADRS) response
Time frame: last visit (treatment session 20, an average of four weeks)
Montgomery Asberg Depression Rating Scale (MADRS) remission
Time frame: last visit (treatment session 20, an average of four weeks)
memory objective
Time frame: baseline to last visit (treatment session 20, an average of four weeks)
memory subjective
Time frame: last visit (treatment session 20, an average of four weeks)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: baseline to last visit (treatment session 20, an average of four weeks)
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 13 Mar 2019.
- Individual participant dataSharing planned: No
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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.
johan lundberg, MD PhD principal investigator
Norra Stockholms Psykiatri and Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dTMS in people with MAjor Depressive Disorder, run by Section for Affective Disorders; Northern Stockholm Psychiatry at 1 site in Sweden.
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 1 inclusion and 1 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 13 Mar 2019. 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 Sweden. 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. 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?
Montgomery Asberg Depression Rating Scale (MADRS) score (time frame: baseline to last visit (treatment session 20, an average of four weeks)). 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 13 Mar 2019.