DepressionNCT02260765
Post Marketing Study to Evaluate the Resource Utilization of Patients Suffering From Resistant Depression Treated With Deep TMS in Comparison to Treatment as Usual
A study testing dTMS in people with Depression, run by Brainsway at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- dTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Sep 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients
- Patients at Healthcare Partners for at least one year
- Men and women 22-68 years of age
- Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed in Health Care Partners (HCP) database by ICD-9 diagnosis code
- Subject with QIDS score > 14 Subject with an HDRS-21 score > 22
- If treating with antidepressants patient should be stable on treatment for at least 30 days prior to baseline visit or 45 days in case of Fluoxetine
- Capable and willing to provide informed consent
- Able to adhere to the treatment schedule
Who cannot join
- QIDS-SR item 12 " Thoughts of Death or Suicide " score ≥3 or HDRS- 21 item 3 "Suicidal Ideation" score ≥3
- Depression secondary to a general medical condition, or substance- induced;
- History of substance abuse or dependence within the past 6 month (except nicotine and caffeine)
- Schizophrenic disorder
- Schizoaffective disorder
- Bipolar disorder, except when mania/hypomania was related to administration of antidepressant medications
Show all 18Show fewer
- Major depression with psychotic features in the current episode
- Delusional disorder (current or within the past year)
- Eating disorders (current or within the past year)
- Obsessive compulsive disorder (current or within the past year)
- Post-traumatic stress disorder (current or within the past year)
- Current (or within 12 months of baseline) generalized anxiety disorder, panic disorder or social anxiety disorder as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
- Current (or within 12 months of baseline) personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD.
- Patients who have conductive, ferromagnetic or other magnetic- sensitive metals implanted in their head or within 30 cm of the treatment coil. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes
- Patients who have active or inactive implants (including device leads), including cardiac pacemakers, implanted defibrillators, deep brain stimulators, cochlear implants, and vagus nerve stimulators
- Known or suspected pregnancy
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse
- Minimal MT found for both hands is higher than 70% of stimulator power output
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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.
- Conditions
- Depression
- Being tested
- dTMS
- Keywords
- Treatment as Usual = TAU
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dTMSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| HCP dTMS | Active comparator | this arm will receive dTMS treatment Receives: Device: dTMS |
| HCP TAU | No intervention | this arm will continue with the same drugs that they are using usually, which mean treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 4 week from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: This study was never funded therefore no patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Alexander Bystritsky, MD, PhD, Principal investigator, Healthcare Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260765
- Sponsor's protocol ID
- HCP-Post Marketing-Brainsway
- Status last verified
- Feb 2021
- First submitted
- 6 Oct 2014
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Study to Evaluate the Resource Utilization of Patients Suffering From Resistant Depression Treated With Deep TMS in Comparison to Treatment as Usual
- ClinicalTrials.gov ID
- NCT02260765
- Acronym / sponsor ID
- HCP-Post Marketing-Brainsway
- Conditions
- Depression
- Keywords
- Treatment as Usual = TAU
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was never funded therefore no patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 9 Oct 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 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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCP dTMS | Active comparator | Device: dTMSthis arm will receive dTMS treatment |
| HCP TAU | No intervention | –this arm will continue with the same drugs that they are using usually, which mean treatment as usual |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Outpatients
- Patients at Healthcare Partners for at least one year
- Men and women 22-68 years of age
- Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed in Health Care Partners (HCP) database by ICD-9 diagnosis code
- Subject with QIDS score > 14 Subject with an HDRS-21 score > 22
Key exclusion criteria (18 listed)
- QIDS-SR item 12 " Thoughts of Death or Suicide " score ≥3 or HDRS- 21 item 3 "Suicidal Ideation" score ≥3
- Depression secondary to a general medical condition, or substance- induced;
- History of substance abuse or dependence within the past 6 month (except nicotine and caffeine)
- Schizophrenic disorder
- Schizoaffective disorder
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 |
|---|---|---|
| dTMSThe 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 | Device | HCP dTMS |
Primary outcome
HDRS-21
Time frame: Baseline and after 4 week from the baseline
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
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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.
Alexander Alexander Bystritsky, MD, PhD principal investigator
Healthcare Partners
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dTMS in people with Depression, run by Brainsway at 1 site in United States.
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 18 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: withdrawn, as of the sponsor's last update on 8 Feb 2021. 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 United States. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
HDRS-21 (time frame: Baseline and after 4 week from the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2021.