Major Depressive DisorderNCT03571412
Antidepressive Effect on 5 Herz (Hz) rTMS Over Dorsomedial Prefrontal Cortex and Left Dorsolateral Prefrontal Cortex
A study testing repetitive Transcranial Magnetic Stimulation in people with Major Depressive Disorder, run by Universidad Autonoma de Queretaro.
Trial summary
This study evaluates the efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex on Major Depressive Disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2016to 1 Sep 2017
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years old.
- Meet DSM 5 (Diagnostic and Statistical Manual, 5 edition) diagnostic criteria for Major Depressive Disorder.
- Score >17 in Hamilton Depression Rating Scale.
Who cannot join
- Subjects with diagnose of Psychotic Depression, Schizophrenia, Bipolar Disorder, Post Traumatic Stress Disorder.
- Subjects with epilepsy or presence of paroxysms during the EEG.
- Subjects with previous history of traumatic brain injury, metal plates in the skull, cochlear devices, infusion devices such as insulin pumps.
About this study
Official title: Comparative of Antidepressive Effect on 5Hz rTMS on Dorsomedial Prefrontal Cortex and Left Dorsolateral Prefrontal Cortex
This study evaluates the efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex on Major Depressive Disorder (MDD).
Read the detailed description
Major Depressive Disorder (MDD) affects a significant percentage of the national population (17-20%) in 2:1 ratio in women compared to men. Repetitive Transcranial Magnetic Stimulation (rTMS) is an effective neuromodulation technique for the treatment of Major Depressive Disorder and it has demonstrated favorable clinical effects when applied over the Left Dorsolateral Prefrontal Cortex (LDLPFC); however there is evidence that other areas of the prefrontal cortex such as the Dorsomedial Prefrontal Cortex (DMPFC) could be ideal for rTMS treatment targets during the presence of MDD, given its association with deficient cognitive processes during the course of the illness. There is also evidence of the use of 5Hz frequency with the same clinical effectiveness from other frequencies such as 10 Hz and 20 Hz when applied to the LDLPFC. However, there are no current research that have addressed the use of this frequency on DMPFC.
- Conditions
- Major Depressive Disorder
- Being tested
- repetitive Transcranial Magnetic Stimulation
- Keywords
- Depression, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic StimulationDevice
Also called Transcranial Magnetic Stimulation
Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS
| Study group | Role | What they receive |
|---|---|---|
| 5Hz Left Dorsolateral Prefrontal Cortex | Experimental | This group will receive 5Hz Left Dorsolateral Prefrontal Cortex repetitive Transcranial Magnetic Stimulation. Once a day on monday to friday. Until complete 15 sessions.After complete acute phase intervention (15 sessions) subject will have a 5 week clinical follow up. Receives: Device: repetitive Transcranial Magnetic Stimulation |
| 5Hz Dorsomedial Prefrontal Cortex | Experimental | This group will receive 5Hz Dorsomedial Prefrontal Cortex Transcranial Magnetic Stimulation, once a day on monday to friday. Until complete 15 sessions.After complete acute phase intervention (15 sessions) subject will have a 5 week clinical follow up. Receives: Device: repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depressive symptoms evaluated by Hamilton Depressive Rating Scale (HADRS)
Hamilton Depressive Rating Scale (HADRS) is a 21 item clinimetric scale to evaluate severity of depressive symptoms in patients.
Measured: 3 weeks
Secondary outcomes (1)
Changes in depressive symptoms evaluated by Montgomery-Asberg Depressive Rating Scale (MADRS)
Montgomery- Asberg Depressive Rating Scale (MADRS) is a 10 item clinimetric scale that evaluates the presence and severity of depressive symptoms in subjects with the disorder mentioned before.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start8 Aug 2016
- Primary completion31 Jul 2017
- Study completion1 Sep 2017
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
- Model description
- The purpose to this study is to valuate the clinical effects of 5Hz rTMS over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Julian Reyes López, Universidad Autonoma de Queretaro
- Investigators
- Julian Reyes, PhD, Study director, Universidad Autónoma de Querétaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571412
- Sponsor's protocol ID
- 01-05/05/2016
- Status last verified
- Apr 2019
- First submitted
- 10 Jan 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative of Antidepressive Effect on 5Hz rTMS on Dorsomedial Prefrontal Cortex and Left Dorsolateral Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT03571412
- Acronym / sponsor ID
- 01-05/05/2016
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad Autonoma de QueretaroUniversity, hospital or other
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 27 Jun 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.
This study evaluates the efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex on Major Depressive Disorder (MDD).
Detailed description
Major Depressive Disorder (MDD) affects a significant percentage of the national population (17-20%) in 2:1 ratio in women compared to men. Repetitive Transcranial Magnetic Stimulation (rTMS) is an effective neuromodulation technique for the treatment of Major Depressive Disorder and it has demonstrated favorable clinical effects when applied over the Left Dorsolateral Prefrontal Cortex (LDLPFC); however there is evidence that other areas of the prefrontal cortex such as the Dorsomedial Prefrontal Cortex (DMPFC) could be ideal for rTMS treatment targets during the presence of MDD, given its association with deficient cognitive processes during the course of the illness. There is also evidence of the use of 5Hz frequency with the same clinical effectiveness from other frequencies such as 10 Hz and 20 Hz when applied to the LDLPFC. However, there are no current research that have addressed the use of this frequency on DMPFC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The purpose to this study is to valuate the clinical effects of 5Hz rTMS over Left Dorsolateral Prefrontal Cortex and Dorsomedial Prefrontal Cortex
| Arm | Type | Receives |
|---|---|---|
| 5Hz Left Dorsolateral Prefrontal Cortex | Experimental | Device: repetitive Transcranial Magnetic StimulationThis group will receive 5Hz Left Dorsolateral Prefrontal Cortex repetitive Transcranial Magnetic Stimulation. Once a day on monday to friday. Until complete 15 sessions.After complete acute phase intervention (15 sessions) subject will have a 5 week clinical follow up. |
| 5Hz Dorsomedial Prefrontal Cortex | Experimental | Device: repetitive Transcranial Magnetic StimulationThis group will receive 5Hz Dorsomedial Prefrontal Cortex Transcranial Magnetic Stimulation, once a day on monday to friday. Until complete 15 sessions.After complete acute phase intervention (15 sessions) subject will have a 5 week clinical follow up. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-45 years old.
- Meet DSM 5 (Diagnostic and Statistical Manual, 5 edition) diagnostic criteria for Major Depressive Disorder.
- Score >17 in Hamilton Depression Rating Scale.
Key exclusion criteria (3 listed)
- Subjects with diagnose of Psychotic Depression, Schizophrenia, Bipolar Disorder, Post Traumatic Stress Disorder.
- Subjects with epilepsy or presence of paroxysms during the EEG.
- Subjects with previous history of traumatic brain injury, metal plates in the skull, cochlear devices, infusion devices such as insulin pumps.
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 |
|---|---|---|
| repetitive Transcranial Magnetic StimulationAlso: Transcranial Magnetic StimulationSubject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS | Device | 5Hz Dorsomedial Prefrontal Cortex, 5Hz Left Dorsolateral Prefrontal Cortex |
Primary outcome
Changes in depressive symptoms evaluated by Hamilton Depressive Rating Scale (HADRS)
Time frame: 3 weeks
Hamilton Depressive Rating Scale (HADRS) is a 21 item clinimetric scale to evaluate severity of depressive symptoms in patients.
1 secondary outcome
Changes in depressive symptoms evaluated by Montgomery-Asberg Depressive Rating Scale (MADRS)
Time frame: 3 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 16 Apr 2019.
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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.
Julian Reyes, PhD study director
Universidad Autónoma de Querétaro
Questions about this trial
What is this clinical trial studying?
A study testing repetitive Transcranial Magnetic Stimulation in people with Major Depressive Disorder, run by Universidad Autonoma de Queretaro.
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 3 inclusion and 3 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in depressive symptoms evaluated by Hamilton Depressive Rating Scale (HADRS) (time frame: 3 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 16 Apr 2019.