DepressionNCT03708172
rTMS and Cognitive Training in Youth Depression
A study testing Repetitive Transcranial Magnetic Stimulation and Cognitive Training in people with Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Youth depression is a highly prevalent disorder with tremendous personal and societal costs. Guideline supported treatments are limited in efficacy and associated with side effects. Novel, safe, and effective treatments are sorely needed. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Depression
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation and Cognitive Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2017to 31 May 2019
- 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 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- outpatients
- between the ages of 16 and 24
- competent to consent to study participation
- Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD single or recurrent
- not taking any oral medication for depression or another psychiatric indication 1-week prior to screening visit
- HRSD-17 score of 20 and higher, to be reviewed on a case by case basis by the study psychiatrists
- at least one failed/refused/intolerant to antidepressant trial in the current episode as determined by ATHF
- No safety concerns endorsed on TMS Screening and Information Form
Who cannot join
- lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, delusional disorder, current psychotic symptoms, obsessive compulsive disorder, autism spectrum disorder, a history of epilepsy or any other major neurological disorder
- diagnosis of borderline personality disorder, assessed on a case by case basis
- at least 6 answers coded "yes" in both substance abuse and dependence sections combined, within the last 3 months as determined by MINI
- concomitant major unstable medical illness
- acutely suicidal or high risk for suicide as assessed by a study psychiatrist
- not eligible to receive TMS or MRI as indicated by TMS Screening and Information Form
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- medications are considered a confound including selective serotonin reuptake inhibitors, benzodiazepines, antipsychotics, mood stabilizers, stimulants and anticonvulsants, all to be reviewed on a case by case basis
- have failed brain stimulation in the past
- cannot be an expert musician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: rTMS and Cognitive Training for Treating Youth Depression
Youth depression is a highly prevalent disorder with tremendous personal and societal costs. Guideline supported treatments are limited in efficacy and associated with side effects. Novel, safe, and effective treatments are sorely needed. This study will examine the biological targets, and efficacy, of cognitive training in combination with repetitive transcranial magnetic stimulation (rTMS) in non-medicated, depressed youth. If positive, the investigators will have identified an effective, safe, and acceptable alternative treatment for a population with few treatment options. Identifying biological mechanisms of response will ultimately enable clinicians to tailor individual interventions for depressed youth.
Read the detailed description
Youth depression affects roughly 10% of the North American population, effecting high costs to both individuals and society at large. Unfortunately, few effective treatments exist. Antidepressant medications such as selective serotonergic reuptake inhibitors (SSRIs) are associated with side effects, and possess marginal efficacy in this age group. Black box warnings persist for antidepressants used in those under 24, owing to concerns that these medications enhance suicidal ideation in this population. While guidelines and randomized controlled trials support the use of cognitive behavior therapy (CBT) as a standalone or combination treatment for depressed youth, a large proportion of youth do not respond to either medication or psychotherapy.
The study investigators propose to examine the efficacy of repetitive transcranial magnetic stimulation (rTMS) in conjunction with cognitive training (CT) for depressed youth. rTMS delivered to the dorsolateral prefrontal cortex (DLPFC) is a safe and FDA approved treatment for adults with treatment-resistant depression, and preliminary studies suggest its safety, acceptability, and efficacy in depressed youth. Theta-burst stimulation (TBS) is a new form of rTMS that can achieve antidepressant effects in a quarter of the time of conventional rTMS. TBS is also thought to enhance neural plasticity. In this study, all participants will receive daily (5x a week on weekdays) open-label TBS. In addition, half of the participants will receive computer-based CT designed to enhance executive function, while the other half will receive placebo CT. This approach may capitalize on rTMS-induced neural plasticity, while improving depression associated executive dysfunction.
Aim:
- to investigate the efficacy of combination cognitive training and rTMS applied to the DLPFC in youth depression, and
- to identify biological targets and predictors of response to combined CT and rTMS intervention in youth depression
- Conditions
- Depression
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Cognitive Training, sham Cognitive Training
- Keywords
- rTMS, Depression, Youth, TBS, Brain Stimulation, Electrophysiology, Imaging
- Medical subject headings
- 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 MagPro rTMS Device (Magventure A/S, Farum, Denmark)
Intermittent TBS (iTBS) rTMS applied to the left Dorsolateral Prefrontal Cortex (DLPFC) + continuous TBS (cTBS) rTMS applied to the right DLPFC. The order will be counterbalanced. Administration of this treatment takes roughly 10 minutes. This treatment will be applied daily, 5 days/week, for 4 weeks.
Cognitive TrainingOther
Computer-based cognitive training designed to enhance executive function
sham Cognitive TrainingOther
Computer-based inactive sham training
| Study group | Role | What they receive |
|---|---|---|
| rTMS + Cognitive Training | Active comparator | Participants will receive repetitive transcranial magnetic stimulation (rTMS) in an open label fashion. In addition, participants will receive active cognitive training (CT) which consists of completing computer-based tasks designed to enhance executive function. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Other: Cognitive Training |
| rTMS + Sham Cognitive Training | Sham comparator | Participants will receive repetitive transcranial magnetic stimulation (rTMS) in an open label fashion. In addition, participants will receive sham cognitive training (CT) which consists of completing computer-based tasks. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Other: sham Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 17
Hamilton Rating Scale for Depression (17-item version)
- This scale is used to quantify the severity of symptoms of depression
- Scale range: 0-52 (total score)
- Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
- Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: 5 weeks
Secondary outcomes (2)
Improvement in self-reported symptom severity of depression as measured by the Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II) is 21-item self-report instrument intended to assess the existence and severity of symptoms of depression
- Items are rated on a 4-point scale ranging from 0 to 3
- Scale range: 0-63 (total score)
- Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
- Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
Measured: 5 weeks
Improvement in symptom severity of depression as measured by the Children's Depression Rating Scale, revised-version (CDRS-R) in youth under 18 years of age
The CDRS-R is a clinician-administered 17-item interview, with item ratings between 1 (=no difficulties) and 5 or 1 and 7(=clinically significant difficulties) (adding up to a total score between 17 to 113). It has been proposed, that a score of ≥40 indicates depressive symptomatology, whereas a score ≤28 was often used as indicative of remission within trials.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Aug 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Z. J. Daskalakis, Centre for Addiction and Mental Health
- Investigators
- Z. Jeffrey Daskalakis, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708172
- Sponsor's protocol ID
- 100-2016
- Status last verified
- Oct 2019
- First submitted
- 12 Oct 2018
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dhami P, Moreno S, Croarkin PE, Blumberger DM, Daskalakis ZJ, Farzan F. Baseline markers of cortical excitation and inhibition predict response to theta burst stimulation treatment for youth depression. Sci Rep. 2023 Nov 4;13(1):19115. doi: 10.1038/s41598-023-45107-1.
PubMed 37925557
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS and Cognitive Training for Treating Youth Depression
- ClinicalTrials.gov ID
- NCT03708172
- Acronym / sponsor ID
- 100-2016
- Conditions
- Depression
- Keywords
- rTMS, Depression, Youth, TBS, Brain Stimulation, Electrophysiology, Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 17 Oct 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.
Youth depression is a highly prevalent disorder with tremendous personal and societal costs. Guideline supported treatments are limited in efficacy and associated with side effects. Novel, safe, and effective treatments are sorely needed. This study will examine the biological targets, and efficacy, of cognitive training in combination with repetitive transcranial magnetic stimulation (rTMS) in non-medicated, depressed youth. If positive, the investigators will have identified an effective, safe, and acceptable alternative treatment for a population with few treatment options. Identifying biological mechanisms of response will ultimately enable clinicians to tailor individual interventions for depressed youth.
Detailed description
Youth depression affects roughly 10% of the North American population, effecting high costs to both individuals and society at large. Unfortunately, few effective treatments exist. Antidepressant medications such as selective serotonergic reuptake inhibitors (SSRIs) are associated with side effects, and possess marginal efficacy in this age group. Black box warnings persist for antidepressants used in those under 24, owing to concerns that these medications enhance suicidal ideation in this population. While guidelines and randomized controlled trials support the use of cognitive behavior therapy (CBT) as a standalone or combination treatment for depressed youth, a large proportion of youth do not respond to either medication or psychotherapy.
The study investigators propose to examine the efficacy of repetitive transcranial magnetic stimulation (rTMS) in conjunction with cognitive training (CT) for depressed youth. rTMS delivered to the dorsolateral prefrontal cortex (DLPFC) is a safe and FDA approved treatment for adults with treatment-resistant depression, and preliminary studies suggest its safety, acceptability, and efficacy in depressed youth. Theta-burst stimulation (TBS) is a new form of rTMS that can achieve antidepressant effects in a quarter of the time of conventional rTMS. TBS is also thought to enhance neural plasticity. In this study, all participants will receive daily (5x a week on weekdays) open-label TBS. In addition, half of the participants will receive computer-based CT designed to enhance executive function, while the other half will receive placebo CT. This approach may capitalize on rTMS-induced neural plasticity, while improving depression associated executive dysfunction.
Aim:
- to investigate the efficacy of combination cognitive training and rTMS applied to the DLPFC in youth depression, and
- to identify biological targets and predictors of response to combined CT and rTMS intervention in youth depression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS + Cognitive Training | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation, Other: Cognitive TrainingParticipants will receive repetitive transcranial magnetic stimulation (rTMS) in an open label fashion. In addition, participants will receive active cognitive training (CT) which consists of completing computer-based tasks designed to enhance executive function. |
| rTMS + Sham Cognitive Training | Sham comparator | Device: Repetitive Transcranial Magnetic Stimulation, Other: sham Cognitive TrainingParticipants will receive repetitive transcranial magnetic stimulation (rTMS) in an open label fashion. In addition, participants will receive sham cognitive training (CT) which consists of completing computer-based tasks. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- outpatients
- between the ages of 16 and 24
- competent to consent to study participation
- Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD single or recurrent
- not taking any oral medication for depression or another psychiatric indication 1-week prior to screening visit
Key exclusion criteria (9 listed)
- lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, delusional disorder, current psychotic symptoms, obsessive compulsive disorder, autism spectrum disorder, a history of epilepsy or any other major neurological disorder
- diagnosis of borderline personality disorder, assessed on a case by case basis
- at least 6 answers coded "yes" in both substance abuse and dependence sections combined, within the last 3 months as determined by MINI
- concomitant major unstable medical illness
- acutely suicidal or high risk for suicide as assessed by a study psychiatrist
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: MagPro rTMS Device (Magventure A/S, Farum, Denmark)Intermittent TBS (iTBS) rTMS applied to the left Dorsolateral Prefrontal Cortex (DLPFC) + continuous TBS (cTBS) rTMS applied to the right DLPFC. The order will be counterbalanced. Administration of this treatment takes roughly 10 minutes. This treatment will be applied daily, 5 days/week, for 4 weeks. | Device | rTMS + Cognitive Training, rTMS + Sham Cognitive Training |
| Cognitive TrainingComputer-based cognitive training designed to enhance executive function | Other | rTMS + Cognitive Training |
| sham Cognitive TrainingComputer-based inactive sham training | Other | rTMS + Sham Cognitive Training |
Primary outcome
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 17
Time frame: 5 weeks
Hamilton Rating Scale for Depression (17-item version) * This scale is used to quantify the severity of symptoms of depression * Scale range: 0-52 (total score) * Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) * Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)
2 secondary outcomes
Improvement in self-reported symptom severity of depression as measured by the Beck Depression Inventory-II (BDI-II)
Time frame: 5 weeks
Improvement in symptom severity of depression as measured by the Children's Depression Rating Scale, revised-version (CDRS-R) in youth under 18 years of age
Time frame: 5 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 25 Oct 2019.
- Derived from this study: PubMed 37925557Dhami P, Moreno S, Croarkin PE, Blumberger DM, Daskalakis ZJ, Farzan F. Baseline markers of cortical excitation and inhibition predict response to theta burst stimulation treatment for youth depression. Sci Rep. 2023 Nov 4;13(1):19115. doi: 10.1038/s41598-023-45107-1.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospitalLink provided by the sponsor.
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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.
Z. Jeffrey Daskalakis, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation and Cognitive Training in people with Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 8 inclusion and 9 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 25 Oct 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 Canada. 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?
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 17 (time frame: 5 weeks). 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 NCT03708172, which also lists 1 linked publication.
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 25 Oct 2019.