Major DepressionPhase 4NCT02213016
Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients
A Phase 4 study testing Transcranial Magnetic Stimulation in people with Major Depression, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied vs. 2 sessions / week. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2013to Feb 2017
- Phase
- Phase 4
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of major depressive disorder
- Having a greater or equal score to 18 points in the Ham-D scale at the moment of the initial evaluation
- Treatment free patients
Who cannot join
- Epilepsy or seizure risk record
- Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Mental Health, Faculty of Medicine, UNAM
Mexico City, Mexico City, 04510
Gabriela Armas, MD, +5255 56228222 ext. 43139, drgaba1@gmail.com
Francisco Romo, MD, +5255 56228222 ext. 43137, franciscoromo@yahoo.com
About this study
Official title: Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation on Cognitive, Anxiety and Depressive Symptoms in Patients Diagnosed With Major Depressive Disorder
The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied vs. 2 sessions / week. All patients will receive 15 TMS sessions as initial treatment (active or sham) and respondents will participate in an TMS follow-up on the left DLPFC for three months.
Read the detailed description
This is a randomized, double-blinded, placebo-controlled, parallel group clinical trial to evaluate the efficacy of two Transcranial Magnetic Stimulation (TMS) protocols in patients with major depressive disorder (MDD). 70 ambulatory patients with a MDD diagnosis from the Clinic at the Department of Psychiatry and Mental Health at the Universidad Nacional Autónoma de México (UNAM) will be included. All Patients will complete a total of 15 sessions of treatment in any of four groups: A group of patients will be randomly assigned to receive either 5 active TMS sessions or 2 sessions per week. Sham controls will also be randomly assigned to receive either 5 TMS sessions or 2 sessions per week. Afterwards, all participants will receive 2 sessions per month for a 3 month period. Depressive and anxiety symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment phase, and once at the end of a 3-month follow up. In addition, neuropsychological evaluations will be applied at baseline and at the end of the 15 session's treatment. Sessions will be applied with a MAG pro x 100 transcranial magnetic stimulator. Motor threshold will be set. Sessions will be applied over the left DLPFC at 5 Hz, 30 trains, 100%. Categorical variables will be described by percentages and frequencies. Continuous variables will be described by means and standard deviations. Treatment groups will be compared using Student's T test. Cognitive, anxiety and depressive symptom scale scores between treatment groups will be compared using repeated measures ANOVA.
- Conditions
- Major Depression
- Being tested
- Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
- Keywords
- Stimulation magnetic transcranial, major depression, cognitive impairment
- Medical subject headings
- Depressive Disorder, Major, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called TMS device MagVenture model MagPro 100
Sham Transcranial Magnetic StimulationDevice
Also called TMS device Magventure, model MagPro 100. COIL COOL-B65.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial magnetic stimulation | Sham comparator | Sham repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions. Receives: Device: Sham Transcranial Magnetic Stimulation |
| Transcraneal magnetic stimulation | Active comparator | Active repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions. Receives: Device: Transcranial Magnetic Stimulation |
| Sham Comparator | Sham comparator | Sham repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions. Receives: Device: Sham Transcranial Magnetic Stimulation |
| Active Comparator | Active comparator | Active repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total scores on the Hamilton depression scale depression
Measured: After 15 sessions of treatment and at 3 months follow up
Secondary outcomes (1)
Performance on the Wisconsin card sorting test
Measured: After 15 sessions of treatment and at 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Armas Castañeda, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213016
- Sponsor's protocol ID
- 141-2011
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Unable to connect to PubMed to validate , last attempt on May 29, 2014 at 3:25 PM EDT
Armas-Castaneda G, Ricardo-Garcell J, Reyes JV, Heinze G, Salin RJ, Gonzalez JJ. Two rTMS sessions per week: a practical approach for treating major depressive disorder. Neuroreport. 2021 Dec 8;32(17):1364-1369. doi: 10.1097/WNR.0000000000001737. Epub 2021 Oct 28.
PubMed 34718252
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Repetitive Transcranial Magnetic Stimulation on Cognitive, Anxiety and Depressive Symptoms in Patients Diagnosed With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02213016
- Acronym / sponsor ID
- 141-2011
- Conditions
- Major Depression
- Keywords
- Stimulation magnetic transcranial, major depression, cognitive impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 11 Aug 2014 (estimated)
- 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.
The purpose of this study is to evaluate clinical efficacy (affective and cognitive) in patients with moderate depression between TMS over the left Dorsolateral Prefrontal Cortex (DLPFC) with simulated TMS, as well as clinical response when 5 sessions / week are applied vs. 2 sessions / week. All patients will receive 15 TMS sessions as initial treatment (active or sham) and respondents will participate in an TMS follow-up on the left DLPFC for three months.
Detailed description
This is a randomized, double-blinded, placebo-controlled, parallel group clinical trial to evaluate the efficacy of two Transcranial Magnetic Stimulation (TMS) protocols in patients with major depressive disorder (MDD). 70 ambulatory patients with a MDD diagnosis from the Clinic at the Department of Psychiatry and Mental Health at the Universidad Nacional Autónoma de México (UNAM) will be included. All Patients will complete a total of 15 sessions of treatment in any of four groups: A group of patients will be randomly assigned to receive either 5 active TMS sessions or 2 sessions per week. Sham controls will also be randomly assigned to receive either 5 TMS sessions or 2 sessions per week. Afterwards, all participants will receive 2 sessions per month for a 3 month period. Depressive and anxiety symptoms will be evaluated at baseline, and every 5 TMS sessions during the acute treatment phase, and once at the end of a 3-month follow up. In addition, neuropsychological evaluations will be applied at baseline and at the end of the 15 session's treatment. Sessions will be applied with a MAG pro x 100 transcranial magnetic stimulator. Motor threshold will be set. Sessions will be applied over the left DLPFC at 5 Hz, 30 trains, 100%. Categorical variables will be described by percentages and frequencies. Continuous variables will be described by means and standard deviations. Treatment groups will be compared using Student's T test. Cognitive, anxiety and depressive symptom scale scores between treatment groups will be compared using repeated measures ANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transcranial magnetic stimulation | Sham comparator | Device: Sham Transcranial Magnetic StimulationSham repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions. |
| Transcraneal magnetic stimulation | Active comparator | Device: Transcranial Magnetic StimulationActive repetitive Transcranial magnetic stimulation, 5 Hz, 5 sessions per week for three weeks: Total of 15 sessions. |
| Sham Comparator | Sham comparator | Device: Sham Transcranial Magnetic StimulationSham repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions. |
| Active Comparator | Active comparator | Device: Transcranial Magnetic StimulationActive repetitive Transcranial magnetic stimulation, 5 Hz, 2 sessions per week for 7 1/2 weeks: Total of 15 sessions. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of major depressive disorder
- Having a greater or equal score to 18 points in the Ham-D scale at the moment of the initial evaluation
- Treatment free patients
Key exclusion criteria (2 listed)
- Epilepsy or seizure risk record
- Carry metallic objects in the head (such as arterial clips, plates, screws), eye or brain
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: TMS device MagVenture model MagPro 100 | Device | Active Comparator, Transcraneal magnetic stimulation |
| Sham Transcranial Magnetic StimulationAlso: TMS device Magventure, model MagPro 100. COIL COOL-B65. | Device | Sham Comparator, Transcranial magnetic stimulation |
Primary outcome
Total scores on the Hamilton depression scale depression
Time frame: After 15 sessions of treatment and at 3 months follow up
1 secondary outcome
Performance on the Wisconsin card sorting test
Time frame: After 15 sessions of treatment and at 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- BackgroundUnable to connect to PubMed to validate , last attempt on May 29, 2014 at 3:25 PM EDT
- Derived from this study: PubMed 34718252Armas-Castaneda G, Ricardo-Garcell J, Reyes JV, Heinze G, Salin RJ, Gonzalez JJ. Two rTMS sessions per week: a practical approach for treating major depressive disorder. Neuroreport. 2021 Dec 8;32(17):1364-1369. doi: 10.1097/WNR.0000000000001737. Epub 2021 Oct 28.
Related trials for Major Depression
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transcranial Magnetic Stimulation in people with Major Depression, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
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 2 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: status not confirmed, as of the sponsor's last update on 11 Aug 2014. 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 Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Armas-Castañeda, MD (+525556228222 ext. 43139, drgaba1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total scores on the Hamilton depression scale depression (time frame: After 15 sessions of treatment and at 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02213016, which also lists 2 linked publications.
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 11 Aug 2014.