ClinicalTrials.gov
ClinicalTrials.gov Menu

rTMS and Cognitive Training in Youth Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03708172
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Z. J. Daskalakis, Centre for Addiction and Mental Health

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Depression Device: Repetitive Transcranial Magnetic Stimulation Other: Cognitive Training Not Applicable

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:

  1. to investigate the efficacy of combination cognitive training and rTMS applied to the DLPFC in youth depression, and
  2. to identify biological targets and predictors of response to combined CT and rTMS intervention in youth depression

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Open Label for rTMS, Double-Blinded for Cognitive Training
Primary Purpose: Treatment
Official Title: rTMS and Cognitive Training for Treating Youth Depression
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: rTMS + Cognitive Training
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.
Device: Repetitive Transcranial Magnetic Stimulation
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.
Other Name: MagPro rTMS Device (Magventure A/S, Farum, Denmark)

Other: Cognitive Training
Computer-based cognitive training designed to enhance executive function

Placebo Comparator: rTMS + Placebo Cognitive Training
Participants will receive repetitive transcranial magnetic stimulation (rTMS) in an open label fashion. In addition, participants will receive placebo cognitive training (CT) which consists of completing computer-based tasks.
Device: Repetitive Transcranial Magnetic Stimulation
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.
Other Name: MagPro rTMS Device (Magventure A/S, Farum, Denmark)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Improvement in self-reported symptom severity of depression as measured by the Beck Depression Inventory-II (BDI-II) [ Time Frame: 5 weeks ]
    The Beck Depression Inventory-II (BDI-II) is 21-item self-report instrument intended to assess the existence and severity of symptoms of depression

  2. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. outpatients
  2. between the ages of 16 and 24
  3. competent to consent to study participation
  4. Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD single or recurrent
  5. not taking any oral medication for depression or another psychiatric indication 1-week prior to screening visit
  6. HRSD-17 score of 20 and higher, to be reviewed on a case by case basis by the study psychiatrists
  7. at least one failed/refused/intolerant to antidepressant trial in the current episode as determined by ATHF
  8. No safety concerns endorsed on TMS Screening and Information Form

Exclusion Criteria:

  1. 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
  2. diagnosis of borderline personality disorder, assessed on a case by case basis
  3. at least 6 answers coded "yes" in both substance abuse and dependence sections combined, within the last 3 months as determined by MINI
  4. concomitant major unstable medical illness
  5. acutely suicidal or high risk for suicide as assessed by a study psychiatrist
  6. not eligible to receive TMS or MRI as indicated by TMS Screening and Information Form
  7. 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
  8. have failed brain stimulation in the past
  9. cannot be an expert musician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708172


Contacts
Contact: Stacey Shim, MSc 1-416-535-8501 ext 30214 Stacey.Shim@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Stacey Shim, MSc    416-535-8501 ext 30214    Stacey.Shim@camh.ca   
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Z. Jeffrey Daskalakis, MD, PhD Centre for Addiction and Mental Health

Additional Information:
Responsible Party: Z. J. Daskalakis, Chair, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03708172     History of Changes
Other Study ID Numbers: 100-2016
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Z. J. Daskalakis, Centre for Addiction and Mental Health:
rTMS
Depression
Youth
TBS
Brain Stimulation
Electrophysiology
Imaging

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders