Bipolar Disorder, Type 1NCT05501626
Evaluation of Theta-burst Stimulation Efficacy, Safety and Tolerability in Major Depressive Episodes of Bipolar I Disorder
A study testing Active Theta Burst Stimulation (TBS) in people with Bipolar Disorder, Type 1, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
INTRODUCTION: Pharmacological treatment of major depressive episodes in bipolar disorder (BD) is characterized by suboptimal efficacy rates, poor tolerability and adherence, delayed onset of action, and iatrogenic mood swings. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Type 1
- What is being tested?
- Active Theta Burst Stimulation (TBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jul 2022to Aug 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current moderate or severe major depressive episode in bipolar I disorder assessed with Hamilton Depression Rating Scale (HAM-D) score ≥ 17 points.
- Any appropriate first or second line pharmacological regimen in accordance with Canmat guidelines to treat a major depressive episode in bipolar I disorder:
- Quetiapine 300 - 600 mg/dia; Lithium serum levels 0,6 - 1,2 meq/L; Lamotrigine 100 - 200 mg/dia; Lurasidone 20 - 120 mg/dia; Divalproex; Lithium/Divalproex + Lurasidone; Lithium/Divalproex + Lamotrigine; Olanzapine 5 - 20 mg/day + Fluoxetine 20 - 60 mg/day; Lithium/Divalproex + SSRI/Bupropion.
Who cannot join
- Concomitant diagnosis of other neuropsychiatric disorders such as: schizophrenia, dementias, mental retardation, organic mental disorder, or epilepsy;
- Acute suicide ideation (assessed by interview and clinical evaluation);
- Acute psychotic depression (assessed by interview and clinical evaluation);
- Suspected or confirmed pregnancy;
- Women in breastfeeding;
- Severe or unstable clinical disease;
- Previous rTMS treatment;
- Specific contraindications to TBS: previous epileptic seizures; change in electroencephalogram at some point in life; previous stroke; previous severe traumatic brain injury (with neurosurgery); metallic object on head (except mouth) as projectile piece, surgical clip, welding fragments; any implanted device (cardiac pacemaker, intravenous catheter).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Psychiatry, University of Sao Paulo
São Paulo, 05403-010
About this study
Official title: Evaluation of Theta-burst Stimulation Efficacy, Safety and Tolerability in Major Depressive Episodes of Bipolar I Disorder: Randomized, Controlled, Double-blind, Parallel-group Clinical Trial
INTRODUCTION: Pharmacological treatment of major depressive episodes in bipolar disorder (BD) is characterized by suboptimal efficacy rates, poor tolerability and adherence, delayed onset of action, and iatrogenic mood swings. The use of repetitive transcranial magnetic stimulation (rTMS) has been presented as an effective, safe and well-tolerated alternative to the treatment of uni- and bipolar depressive episodes. Recently, a new rTMS protocol was introduced, theta-burst stimulation (TBS), whose studies have shown similar efficacy with a shorter time interval than conventional rTMS. Most clinical trials performed to date evaluate the use of TBS in patients with unipolar depression or mixed samples of uni and bipolar patients. The effectiveness of TBS exclusively in BD has not been properly studied. METHODS: We will perform a 6-week, double-blind, randomized, parallel-group, sham-controlled clinical trial of active or sham TBS. We will recruit 60 patients aged between 18 and 65 years with a diagnosis of BD type I in a current moderate or severe major depressive episode resistant to at least two first- or second-line pharmacological treatments, according to CANMAT guidelines. The primary outcome measure will be the assessment of TBS efficacy through difference in scores on 17-item Hamilton Depression Scale (HAM-D) from baseline until the end of week 6 of intervention between active and sham groups. KEYWORDS: randomized clinical trial; transcranial magnetic stimulation; bipolar affective disorder; major depression.
- Conditions
- Bipolar Disorder, Type 1
- Being tested
- Active Theta Burst Stimulation (TBS), Sham Theta Burst Stimulation (TBS)
- Keywords
- randomized clinical trial, transcranial magnetic stimulation, bipolar affective disorder, major depression
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Theta Burst Stimulation (TBS)Device
Each session will be comprised of ACTIVE TBS: intermittent excitatory stimulation (iTBS) in the left dorsolateral prefrontal cortex totaling 37,800 pulses.
Sham Theta Burst Stimulation (TBS)Device
Each session will be comprised of SHAM TBS: intermittent excitatory stimulation (iTBS) in the left dorsolateral prefrontal cortex totaling 37,800 pulses.
| Study group | Role | What they receive |
|---|---|---|
| Active TBS arm | Active comparator | Patients randomized to this arm will receive active TBS 5 consecutive days of the week (Monday to Friday) in the first 3 weeks and then 2 alternate days of the week (with interval of at least 1 day between sessions) for another 3 weeks comprising 21 sections. Receives: Device: Active Theta Burst Stimulation (TBS) |
| Sham TBS arm | Sham comparator | Patients randomized to this arm will receive sham TBS 5 consecutive days of the week (Monday to Friday) in the first 3 weeks and then 2 alternate days of the week (with interval of at least 1 day between sessions) for another 3 weeks comprising 21 sections. Receives: Device: Sham Theta Burst Stimulation (TBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Change in Hamilton Depression Rating Scale (HAM-D)
Measured: From baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start10 Jul 2022
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder, Type 1Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501626
- Sponsor's protocol ID
- StudyTBS
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- 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 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Theta-burst Stimulation Efficacy, Safety and Tolerability in Major Depressive Episodes of Bipolar I Disorder: Randomized, Controlled, Double-blind, Parallel-group Clinical Trial
- ClinicalTrials.gov ID
- NCT05501626
- Acronym / sponsor ID
- StudyTBS
- Conditions
- Bipolar Disorder, Type 1
- Keywords
- randomized clinical trial, transcranial magnetic stimulation, bipolar affective disorder, major depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 15 Aug 2022 (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.
INTRODUCTION: Pharmacological treatment of major depressive episodes in bipolar disorder (BD) is characterized by suboptimal efficacy rates, poor tolerability and adherence, delayed onset of action, and iatrogenic mood swings. The use of repetitive transcranial magnetic stimulation (rTMS) has been presented as an effective, safe and well-tolerated alternative to the treatment of uni- and bipolar depressive episodes. Recently, a new rTMS protocol was introduced, theta-burst stimulation (TBS), whose studies have shown similar efficacy with a shorter time interval than conventional rTMS. Most clinical trials performed to date evaluate the use of TBS in patients with unipolar depression or mixed samples of uni and bipolar patients. The effectiveness of TBS exclusively in BD has not been properly studied. METHODS: We will perform a 6-week, double-blind, randomized, parallel-group, sham-controlled clinical trial of active or sham TBS. We will recruit 60 patients aged between 18 and 65 years with a diagnosis of BD type I in a current moderate or severe major depressive episode resistant to at least two first- or second-line pharmacological treatments, according to CANMAT guidelines. The primary outcome measure will be the assessment of TBS efficacy through difference in scores on 17-item Hamilton Depression Scale (HAM-D) from baseline until the end of week 6 of intervention between active and sham groups. KEYWORDS: randomized clinical trial; transcranial magnetic stimulation; bipolar affective disorder; major depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TBS arm | Active comparator | Device: Active Theta Burst Stimulation (TBS)Patients randomized to this arm will receive active TBS 5 consecutive days of the week (Monday to Friday) in the first 3 weeks and then 2 alternate days of the week (with interval of at least 1 day between sessions) for another 3 weeks comprising 21 sections. |
| Sham TBS arm | Sham comparator | Device: Sham Theta Burst Stimulation (TBS)Patients randomized to this arm will receive sham TBS 5 consecutive days of the week (Monday to Friday) in the first 3 weeks and then 2 alternate days of the week (with interval of at least 1 day between sessions) for another 3 weeks comprising 21 sections. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current moderate or severe major depressive episode in bipolar I disorder assessed with Hamilton Depression Rating Scale (HAM-D) score ≥ 17 points.
- Any appropriate first or second line pharmacological regimen in accordance with Canmat guidelines to treat a major depressive episode in bipolar I disorder:
- Quetiapine 300 - 600 mg/dia; Lithium serum levels 0,6 - 1,2 meq/L; Lamotrigine 100 - 200 mg/dia; Lurasidone 20 - 120 mg/dia; Divalproex; Lithium/Divalproex + Lurasidone; Lithium/Divalproex + Lamotrigine; Olanzapine 5 - 20 mg/day + Fluoxetine 20 - 60 mg/day; Lithium/Divalproex + SSRI/Bupropion.
Key exclusion criteria (8 listed)
- Concomitant diagnosis of other neuropsychiatric disorders such as: schizophrenia, dementias, mental retardation, organic mental disorder, or epilepsy;
- Acute suicide ideation (assessed by interview and clinical evaluation);
- Acute psychotic depression (assessed by interview and clinical evaluation);
- Suspected or confirmed pregnancy;
- Women in breastfeeding;
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 Theta Burst Stimulation (TBS)Each session will be comprised of ACTIVE TBS: intermittent excitatory stimulation (iTBS) in the left dorsolateral prefrontal cortex totaling 37,800 pulses. | Device | Active TBS arm |
| Sham Theta Burst Stimulation (TBS)Each session will be comprised of SHAM TBS: intermittent excitatory stimulation (iTBS) in the left dorsolateral prefrontal cortex totaling 37,800 pulses. | Device | Sham TBS arm |
Primary outcome
Primary Outcome Measure
Time frame: From baseline to week 6
Change in Hamilton Depression Rating Scale (HAM-D)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Theta Burst Stimulation (TBS) in people with Bipolar Disorder, Type 1, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 8 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 15 Aug 2022. 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 Brazil. 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?
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?
Primary Outcome Measure (time frame: From baseline to week 6). 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 15 Aug 2022.