An interventional study of dTMS in Depression, sponsored by Brainsway. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by Brainsway · Not applicable, Interventional, and Other
The aim of the study is to evaluate the efficacy of the Deep TMS compare to TAU and the different in resource utilization of treating depression with Deep TMS compare to the TAU.
The current study is a prospective semi-naturalistic, randomized study in which depressed patient who failed to respond to at least one medication or could not tolerate at least two antidepressants and are seeking for alternative treatment will be offered to join an open label study. The study designed as double arm study of which patient will have 50% chance to be randomized to one of the study groups.
The study includes two arms. The dTMS study group will be treated according to the cleared FDA treatment protocol of 4 weeks of daily treatment following by additional 12 weeks of biweekly treatment and overall of 44 treatments. The Treatment As Usual arm will be treated by their primary care physician / psychiatrist according to the usual treatment recommend to the patient clinical status
many patients do not respond to antidepressant or could not tolerate the adverse events. Hence, many patients are looking for medical alternatives. Those alternatives include psychotherapy, ECT, and TMS. The direct cost of those treatments is relatively high compare to antidepressants. However, the indirect costs including hospitalizations, physician visit, ER visits, pharmacy claims, labs and adverse events management may increase the overall costs and burden of illness for the health system. This study aims to evaluate the efficacy of the Deep TMS compare to TAU and the different in indirect costs of treating depression with Deep TMS compare to the TAU.
The current study is a prospective semi-naturalistic, randomized study in which depressed patient who failed to respond to at least one medication or couldn't tolerate at least two antidepressants and are seeking for alternative treatment will be offered to join an open label study. Patients eligible for the study will be asked to sign the informed consent. Than patients will be randomized to either Deep TMS treatment or TAU. The Deep TMS study group will receive the TMS treatment protocol as was cleared by the FDA. The TAU study group will be treated by their primary care physician / psychiatrist according to the usual treatment recommend to the patient's clinical status. Patient may continue its current treatment (with / without medications) or switch to a new treatment. However, treatment should be stable for at least 30 days prior to baseline visit except of Fluoxetine in which 45 days are required. Patients will be followed at 4 weeks and 6 month following baseline visit. The deep TMS treatment includes 4 weeks of acute daily treatment (20 treatments) following by 12 weeks of biweekly maintenance treatment. The purpose of the study is to explore the efficacy of the Deep TMS treatment compare to TAU and to investigate the differences in resource utilization between the study groups. The study population will be based on the FDA cleared patient population for the Deep TMS treatment. Safety will be assessed by monitoring of adverse events Other assessment scales will be used during the course of the study. Efficacy will be assessed using the Hamilton Depression Rating Score (HDRS), the self-reported questionnaires the QIDS-SR and the PHQ-9. Quality of life will be assessed by the Q-Les-Q questionnaire. Disability will be assessed by the Sheehan Disability Scale.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
Browse Depression studies →Brainsway is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
this arm will receive dTMS treatment
Device: dTMS
this arm will continue with the same drugs that they are using usually, which mean treatment as usual
The Brainsway H-Coil TMS device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep TMS by means of repetitive pulse trains at a determined frequency
HDRS-21
The primary efficacy endpoint is the change from baseline to 4 weeks visit in HDRS-21 score The change in HDRS-21 from baseline to 4 weeks visit will be compared between the treatment groups using a repeated measures analysis of covariance (ANCOVA, SAS® MIXED procedure). Baseline HDRS-21, antidepressant treatment at baseline, will be used as covariates. Baseline HDRS-21 scores and antidepressant treatment at baseline will be entered as continuous variables so that the potential for co-linearity problems will be minimized. Remission is defined as HDRS-21 score \< 10. The remission rates at week 4 in the two groups will be compared using the Chi-square test or Fisher's exact test, as appropriate.
Time frame: Baseline and after 4 week from the baseline
The record gives a start of Oct 2014, a primary completion of Sep 2020 and a completion of Sep 2020. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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