Treatment Resistant DepressionNCT04076124
Brain-derived Neurotrophic Factor and the Antidepressant Efficacy of Brain Stimulation
A study testing Active rTMS-DLPFC and Active iTBS-DLPFC in people with Treatment Resistant Depression, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study evaluates an association between brain-derived neurotrophic factor(BDNF) polymorphisms and the antidepressant efficacy of transcranial magnetic stimulation device in patients with treatment-resistant depression. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Active rTMS-DLPFC and Active iTBS-DLPFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jul 2019to 31 Dec 2021
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 21 to 70 years of age.
- Diagnosed with the recurrent Major depressive disorder (MDD) and currently having a Major Depressive Episode (MDE)
- Participants failed to respond to at least one adequate antidepressant treatment in their current episode
- Participants have a Clinical Global Impression - Severity score of at least 4 and a total score of at least 18 on the Hamilton Depression Rating Scale (HDRS-17) at both screening and baseline visits ( Day -14 and Day 0)
- Participants must discontinue their antidepressant medications at least for one week ( at least two weeks if Fluoxetine) prior to the TMS intervention and keep antidepressant-free during the study duration.
Who cannot join
- a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria)
- Participants with a lifetime medical history of major systemic illness and clinically significantly abnormal screening examination that might affect safety, study participation, or confound interpretation of study results.
- Participants with a lifetime medical history of neurological disorder records (e.g., stroke, seizure, traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers
- Women with breastfeeding or pregnancy
- Participants with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Taipei Veterans General Hospital
Taipei, 112
Cheng-Ta Li, Professor, +886-2-28757027 ext. 298, ctli2@vghtpe.gov.tw; on5083@msn.com
About this study
Official title: Different Forms of Prefrontal Transcranial Stimulation and Brain-derived Neurotrophic Factor in the Prediction of Antidepressant Efficacy of Brain Stimulation
This study evaluates an association between brain-derived neurotrophic factor(BDNF) polymorphisms and the antidepressant efficacy of transcranial magnetic stimulation device in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e.repetitive transcranial magnetic stimulation treatment, intermittent theta-burst stimulation treatment or sham treatment.
- Conditions
- Treatment Resistant Depression
- Being tested
- Active rTMS-DLPFC, Active iTBS-DLPFC, Sham TBS-DLPFC or Sham rTMS-DLPFC
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMS-DLPFCDevice
Participants in the rTMS active stimulation group will receive 4-week 10 Hz 120% of RMT to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator.
Active iTBS-DLPFCDevice
Participants in the intermittent TBS(iTBS) active stimulation group will receive 4-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator.
Sham TBS-DLPFC or Sham rTMS-DLPFCDevice
Half of the patients in the sham group received 4-week the same iTBS parameter stimulation (sham-iTBS), and the other half received the same rTMS parameter stimulation using a sham coil (sham-rTMS), which also improved the blinding process.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS-DLPFC | Experimental | This active group will receive high-frequency repetitive TMS stimulation. Receives: Device: Active rTMS-DLPFC |
| Active iTBS-DLPFC | Experimental | This active group will receive intermittent theta-burst TMS stimulation. Receives: Device: Active iTBS-DLPFC |
| Sham TBS-DLPFC or Sham rTMS-DLPFC | Sham comparator | Patients in the sham group will receive the same iTBS or rTMS parameter stimulation, performing by a sham coil. Receives: Device: Sham TBS-DLPFC or Sham rTMS-DLPFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in 17-item Hamilton Depression Rating Scale
the altered percentage of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
Measured: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Secondary outcomes (10)
Response rate after 4-week treatment at the end of TMS sessions and three month after.
improvement > 50 % of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)
Remission rate after 4-week treatment
17-item Hamilton Depression Rating Scale ≤7 (range, 0 to 52, with higher scores indicating more depression)
Measured: Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)
Changes in Clinical Global Index
Clinical Global Index
Measured: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Changes in depression severity, rated by self-reported
Depression and Somatic Symptoms Scale, range from 0 to 66 with higher scores indicating more depressive and somatic symptom.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Changes in Young Mania Rating Scale
Young Mania Rating Scale, range from 0 to 60 with higher scores indicating more severe manic symptoms.
Measured: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
The association between BDNF Polymorphism genotype and the antidepressant efficacy of brain stimulation
Val/Val, Met/Met, Val/Met genotype and the efficacy after receiving 4-week treatment. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale
Measured: Baseline, Week 4(day 20)
The association between the value of baseline brain metabolism and the antidepressant efficacy of brain stimulation
baseline PET/MRI.The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale.
Measured: Baseline, Week 4(day 20)
The association between the value of Baseline treatment refractory level and the antidepressant efficacy of brain stimulation
Maudsley staging method. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale.
Measured: Baseline, Week 4(day 20)
The association between the value pf baseline Life event stress scale and the antidepressant efficacy of brain stimulation
Life event stress scale,range from 0 to 1467 with higher scores indicating more life event stress. The antidepressant efficacy defined by the altered percentage of 17-item Hamilton Depression Rating Scale.
Measured: Baseline, Week 4(day 20)
Changes in EEG band before and after brain stimulation
Perform rACC-engaging cognitive task(RECT) before 1-st treatment
Measured: Day 1(pre-RECT, post RECT, post 1st treatment, pre-20th treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start24 Jul 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076124
- Sponsor's protocol ID
- V107C-123
- Status last verified
- Aug 2019
- First submitted
- 26 Jul 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Forms of Prefrontal Transcranial Stimulation and Brain-derived Neurotrophic Factor in the Prediction of Antidepressant Efficacy of Brain Stimulation
- ClinicalTrials.gov ID
- NCT04076124
- Acronym / sponsor ID
- V107C-123
- Conditions
- Treatment Resistant Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Sep 2019 (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.
This study evaluates an association between brain-derived neurotrophic factor(BDNF) polymorphisms and the antidepressant efficacy of transcranial magnetic stimulation device in patients with treatment-resistant depression. In a double-blind design, All patients are randomized to three groups, i.e.repetitive transcranial magnetic stimulation treatment, intermittent theta-burst stimulation treatment or sham treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active rTMS-DLPFC | Experimental | Device: Active rTMS-DLPFCThis active group will receive high-frequency repetitive TMS stimulation. |
| Active iTBS-DLPFC | Experimental | Device: Active iTBS-DLPFCThis active group will receive intermittent theta-burst TMS stimulation. |
| Sham TBS-DLPFC or Sham rTMS-DLPFC | Sham comparator | Device: Sham TBS-DLPFC or Sham rTMS-DLPFCPatients in the sham group will receive the same iTBS or rTMS parameter stimulation, performing by a sham coil. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 21 to 70 years of age.
- Diagnosed with the recurrent Major depressive disorder (MDD) and currently having a Major Depressive Episode (MDE)
- Participants failed to respond to at least one adequate antidepressant treatment in their current episode
- Participants have a Clinical Global Impression - Severity score of at least 4 and a total score of at least 18 on the Hamilton Depression Rating Scale (HDRS-17) at both screening and baseline visits ( Day -14 and Day 0)
- Participants must discontinue their antidepressant medications at least for one week ( at least two weeks if Fluoxetine) prior to the TMS intervention and keep antidepressant-free during the study duration.
Key exclusion criteria (5 listed)
- a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on DSM-IV criteria)
- Participants with a lifetime medical history of major systemic illness and clinically significantly abnormal screening examination that might affect safety, study participation, or confound interpretation of study results.
- Participants with a lifetime medical history of neurological disorder records (e.g., stroke, seizure, traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers
- Women with breastfeeding or pregnancy
- Participants with a current strong suicidal risk (i.e., a score of 4 on item 3 of the HDRS-17)
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 |
|---|---|---|
| Active rTMS-DLPFCParticipants in the rTMS active stimulation group will receive 4-week 10 Hz 120% of RMT to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator. | Device | Active rTMS-DLPFC |
| Active iTBS-DLPFCParticipants in the intermittent TBS(iTBS) active stimulation group will receive 4-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator. | Device | Active iTBS-DLPFC |
| Sham TBS-DLPFC or Sham rTMS-DLPFCHalf of the patients in the sham group received 4-week the same iTBS parameter stimulation (sham-iTBS), and the other half received the same rTMS parameter stimulation using a sham coil (sham-rTMS), which also improved the blinding process. | Device | Sham TBS-DLPFC or Sham rTMS-DLPFC |
Primary outcome
Percentage change in 17-item Hamilton Depression Rating Scale
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
the altered percentage of 17-item Hamilton Depression Rating Scale (range, 0 to 52, with higher scores indicating more depression)
10 secondary outcomes
Response rate after 4-week treatment at the end of TMS sessions and three month after.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)
Remission rate after 4-week treatment
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, week 16 (day 80)
Changes in Clinical Global Index
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Changes in depression severity, rated by self-reported
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
Changes in Young Mania Rating Scale
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)
The association between BDNF Polymorphism genotype and the antidepressant efficacy of brain stimulation
Time frame: Baseline, Week 4(day 20)
The association between the value of baseline brain metabolism and the antidepressant efficacy of brain stimulation
Time frame: Baseline, Week 4(day 20)
The association between the value of Baseline treatment refractory level and the antidepressant efficacy of brain stimulation
Time frame: Baseline, Week 4(day 20)
The association between the value pf baseline Life event stress scale and the antidepressant efficacy of brain stimulation
Time frame: Baseline, Week 4(day 20)
Changes in EEG band before and after brain stimulation
Time frame: Day 1(pre-RECT, post RECT, post 1st treatment, pre-20th treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS-DLPFC and Active iTBS-DLPFC in people with Treatment Resistant Depression, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Sep 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Ta Li, Professor (886 -2- 28757027 ext. 298, ctli2@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in 17-item Hamilton Depression Rating Scale (time frame: Baseline, Week 1, Week 2, Week 3, Week 4(day 20)). 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 3 Sep 2019.