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Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST)

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ClinicalTrials.gov Identifier: NCT03191058
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Centre for Addiction and Mental Health
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for depression. Even with multiple medication trials, 30 - 40% of patients will experience a pharmacologically resistant form of illness. The ineffectiveness of current treatments for major depressive disorder (MDD) coupled with the economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.

Condition or disease Intervention/treatment Phase
Depression Unipolar Depression Treatment Resistant Depression Device: Magnetic Seizure Therapy Device: Electroconvulsive Therapy Not Applicable

Detailed Description:
The study will involve a randomized, double blind, non-inferiority clinical trial with two treatment arms conducted in two international academic medical centers (the Centre for Addiction and Mental Health in Toronto, Canada and UT Southwestern in Dallas, Texas). The investigators are pursuing a non-inferiority clinical trial in an effort to compare MST - a new treatment for TRD - to RUL-UB-ECT. Treatment will be administered two to three days per week. Depression symptoms will be assessed with the 24-item Hamilton Depression Rating Scale (HRSD-24) and suicidality will be assessed with the Scale for Suicidal Ideation (SSI). Remission will be defined as HRSD-24 < or = 10 and a > 60% decrease in scores from baseline on two consecutive ratings. Once a participant reaches remission, a second rating to confirm remission will be conducted immediately before their next scheduled treatment. If remission is confirmed, they will then be considered a completer of the acute treatment course. Remission of suicidal ideation is defined as a score of 0 on the SSI. Therefore, there will be no specific minimum number of treatments that patients must receive to be classified as remitters. However, patients who do not meet remission criteria after 21 treatment sessions will be considered non-remitters and will cease treatment sessions. This maximum treatment number was chosen allowing for the possibility that MST may require more treatment sessions to achieve remission, similar to RUL-UB ECT. The blind will not be broken to participants until the completion of the entire study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a randomized, double blind, parallel--group clinical trial with two treatment arms conducted both at the University of Texas Southwestern in Dallas, Texas and at the Temerty Centre for Therapeutic Brain Intervention based at CAMH in Toronto, Canada. Both sites aim to recruit 130 participants each.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Participants will be randomized into the study using a permuted block method with a random number generator. The study statistician will prepare the randomization scheme. The block size will be fixed and study personnel will be blinded to the randomization block size.
Primary Purpose: Treatment
Official Title: Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST - MST)
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: Magnetic Seizure Therapy (MST)
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Device: Magnetic Seizure Therapy

MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).

This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.

Other Name: MST

Active Comparator: Electroconvulsive Therapy (ECT)
ECT treatments will be administered using the MECTA spECTrum 5000Q.
Device: Electroconvulsive Therapy
In the ECT arm treatment, the MECTA spectrum 5000Q machine will be used, which is an FDA approved device used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
Other Name: ECT




Primary Outcome Measures :
  1. Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24 (HRSD-24) [ Time Frame: 7 weeks ]

    Hamilton Rating Scale for Depression (24-item version):

    • This scale is used to quantify the severity of symptoms of depression
    • Scale range: 0-76 (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. Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT) [ Time Frame: 7 weeks ]

    Autobiographical Memory Test:

    -Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.



Secondary Outcome Measures :
  1. Improvement in symptom severity of Suicidal Ideation as measured by the Scale for Suicidal Ideation (SSI) [ Time Frame: 7 weeks ]

    Scale for Suicidal Ideation:

    • This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas
    • Scale range: 0 - 38 (total score)
    • Lower scores indicate lower severity of suicidal ideation (i.e., better outcome)
    • Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients will be included if they:

  1. are inpatients or outpatients;
  2. are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
  3. have a MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic MDD
  4. are 18 years of age or older
  5. have a baseline HRSD-24 score > or = 21;
  6. are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
  7. are agreeable to keeping their current antidepressant treatment constant during the intervention;
  8. are able to adhere to the intervention schedule;
  9. meet the MST safety criteria [75];
  10. If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.

Exclusion Criteria

Patients will be excluded if they:

  1. have a history of MINI diagnosis of substance dependence or abuse within the past three months;
  2. have a concomitant major unstable medical illness;
  3. are pregnant or intend to get pregnant during the study;
  4. have a MINI diagnosis of any primary psychotic disorder
  5. have a MINI diagnosis of obsessive compulsive disorder, or post-traumatic stress disorder deemed to be primary and causing more functional impairment than the depressive disorder
  6. have probable dementia based on study investigator assessment;
  7. have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
  8. present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
  9. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
  10. require a benzodiazepine with a dose > lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;
  11. are unable to communicate in English fluently enough to complete the neuropsychological tests;
  12. have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).

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): NCT03191058


Contacts
Contact: Z. Jeffrey Daskalakis, MD, PhD 416-535-8501 ext 34319 jeff.daskalakis@camh.ca
Contact: Julia Dimitrova, MSc 416-535-8501 ext 30925 julia.dimitrova@camh.ca

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8898
Contact: Mustafa M Husain, MD    214-648-2806    mustafa.husain@utsouthwestern.edu   
Contact: Lucy Palmer, PhD    214-648-0401    Lucy.Palmer@UTSouthwestern.edu   
Principal Investigator: Mustafa M Husain, MD         
Canada, Ontario
Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Z. Jeffrey Daskalakis, MD, PhD    (416) 535-8501 ext 34319    Jeff.Daskalakis@camh.ca   
Contact: Julia Dimitrova, MSc    (416) 535-8501 ext 30925    julia.dimitrova@camh.ca   
Principal Investigator: Z. Jeffrey Daskalakis, MD, PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Mental Health (NIMH)
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Z. Jeffrey J Daskalakis, MD, PhD Centre for Addiction and Mental Health

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03191058     History of Changes
Other Study ID Numbers: CREST-MST
1R01MH112815-01 ( U.S. NIH Grant/Contract )
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by University of Texas Southwestern Medical Center:
Depression
Unipolar Depression
Treatment Resistant Depression
Magnetic Seizure Therapy
Suicidal Ideation
Electroconvulsive Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Seizures
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms