Suicide and DepressionNCT06289842
Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients
A study testing Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark) in people with Suicide and Depression, run by Zagazig University at 1 site in Egypt.
Trial summary
The objective of this study is to investigate efficacy of accelerated theta burst stimulation (TBS) in suicidal reduction in patients with unipolar and bipolar depression Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Suicide and Depression
- What is being tested?
- Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to Jan 2026
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Major depressive episode as a part of MDD or bipolar (I or II) disorder and confirmed by Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I). (First \& Gibbon.,2004 ).
- Meeting the severe depression cutoff for MADRS (>/=35) at baseline visit.
- Meeting the severe depression cutoff for BDI-II (>/=30) at baseline visit.
- Presence of suicidal ideation and/or behavior (confirmed with Columbia Scale for the Rating of Suicide Severity (C-SSRS)
- Adults (Age 19 years or older )
- Right handedness
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- Both genders
- Able to provide informed consent to participate in the study
- Participants were required to have been taking a stable pharmacological regimen for 2 weeks before screening.
- Pass the TMS adult safety screening (TASS) questionnaire
Who cannot join
- Current substance use disorder during the past 3 months
- Current psychotic disorder or symptoms
- Presence of dementia
- Presence of major medical illness, for example metastatic cancer, end stage renal disease
- Inability to verify contact information.
- Presence of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes
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- Conductive, ferromagnetic or other magnetic sensitive metals that are implanted or are non-removable within 30 cm treatment coil (around the head)
- Presence of hypomanic symptoms (score on Young Mania Rating Scale (YMRS) greater than 12)
- Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
- Using lorazepam greater than 2 mg daily (or equivalent) due to the potential to limit rTMS efficacy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University
Zagazig, 44519
Medhat M Bassiony, Professor
Usama M Youssef, Professor
About this study
Official title: Efficacy of Accelerated Theta Burst Stimulation for Treatment of Suicidality in Patients With Unipolar and Bipolar Depression
The objective of this study is to investigate efficacy of accelerated theta burst stimulation (TBS) in suicidal reduction in patients with unipolar and bipolar depression
Read the detailed description
Introduction:
Depression is the leading cause of disability worldwide and is associated with increased suicide risk, morbidity and mortality.(Sousa et al .,2022).
In severe cases, depression can result in suicide and approximately 800,000 suicides occur each year (Lepine et al.,2011). Rates of completed suicide are also high, varying from 10 to 19% (Goodwin et al., 1990). Lifetime rates of attempted suicide in bipolar depression range (26-29%) and (14-16%) in unipolar depression disorder (Chen et al., 1996).
The general recommendation to reduce suicide risk is the effective treatment of the underlying depressive disorder, with medications and psychosocial interventions (Jacobs et al., 2010). However, there exist several difficulties. Neither antidepressants nor psychotherapy work fast enough for reduction of suicidal ideation.
Beside pharmacotherapy and psychotherapy brain stimulation methods have gained increasing relevance in the treatment of depression during the last decades (Baeken et al.,2019).
Repetitive transcranial magnetic stimulation (rTMS) therapy is a noninvasive neurostimulation treatment that has been adopted as a first-line treatment for pharmacotherapy-resistant major depressive disorder (MDD) (Milev et al., 2016).
Despite this growing evidence base supporting (iTBS) in the treatment of MDD, evidence for its efficacy in the treatment of suicidality as a primary outcome in both unipolar and bipolar depressive patients is still lacking.
Hypothesis We assume that accelerated TBS is effective in treatment of suicidality as well as depressive symptoms in both unipolar and bipolar patients.
Aim This study aims to reduce morbidity and mortality of unipolar and bipolar depressive patients and to improve overall functioning.
Objectives
- To investigate efficacy of accelerated TBS in suicidal reduction as primary outcome in patients with unipolar and bipolar depression.
- To compare efficacy of accelerated TBS in reduction of severity of depressive symptoms in unipolar and bipolar disorder as well as response and remission rates.
- To investigate association between the reduction of suicidality and the reduction of depressive symptoms
- Conditions
- Suicide and Depression
- Being tested
- Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark)
- Medical subject headings
- Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark)Device
TMS Therapy System with Theta Burst Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Unipolar depressed patients with suicidality | Active comparator | The participants will receive iTBS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (LDLPFC) determined using Beam method for 1800 pulses with an intertreatment interval of fifty minutes. Stimulation was at 120% of resting motor threshold. Patients received ten sessions every day for five consecutive days for a total of fifty sessions (90,000 pulses). Receives: Device: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark) |
| Bipolar depressed patients with suicidality | Active comparator | The participants will receive iTBS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (LDLPFC) determined using Beam method for 1800 pulses with an intertreatment interval of fifty minutes. Stimulation was at 120% of resting motor threshold. Patients received ten sessions every day for five consecutive days for a total of fifty sessions (90,000 pulses). Receives: Device: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in suicidal ideation and behaviors as measured by Columbia Suicide Severity Rating Scale (C-SSRS)
The SI severity scale is composed of five yes=no questions of increasingly severe suicidal thoughts: a wish to be dead (1), non-specific suicidal thoughts (2), suicidal thoughts with a method (3), suicidal intent without specific plan (4), and suicidal intent with specific plan (5).
This scale was scored from 0 to 5 according to the most severe suicidal ideation endorsed. Higher scores mean worse outcome.
Suicidal behaviors were assessed dichotomously (yes=no) and include actual suicide attempts, interrupted suicide attempts, aborted suicide attempts, other preparatory acts (e.g., collecting pills, writing suicide note), and non-suicidal self-injury (NSSI).
Measured: Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month , 6 month, 9 month and 12 month
Secondary outcomes (1)
Change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) Score
The Montgomery-Åsberg Depression Rating Scale (MADRS), is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Measured: Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month , 6 month ,9 months and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Feb 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide and DepressionStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Medhat Bassiony, Zagazig University
- Investigators
- Medhat M Bassiony, Professor, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289842
- Sponsor's protocol ID
- ZU-IRB #9697
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Accelerated Theta Burst Stimulation for Treatment of Suicidality in Patients With Unipolar and Bipolar Depression
- ClinicalTrials.gov ID
- NCT06289842
- Acronym / sponsor ID
- ZU-IRB #9697
- Conditions
- Suicide and Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 4 Mar 2024 (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.
The objective of this study is to investigate efficacy of accelerated theta burst stimulation (TBS) in suicidal reduction in patients with unipolar and bipolar depression
Detailed description
Introduction:
Depression is the leading cause of disability worldwide and is associated with increased suicide risk, morbidity and mortality.(Sousa et al .,2022).
In severe cases, depression can result in suicide and approximately 800,000 suicides occur each year (Lepine et al.,2011). Rates of completed suicide are also high, varying from 10 to 19% (Goodwin et al., 1990). Lifetime rates of attempted suicide in bipolar depression range (26-29%) and (14-16%) in unipolar depression disorder (Chen et al., 1996).
The general recommendation to reduce suicide risk is the effective treatment of the underlying depressive disorder, with medications and psychosocial interventions (Jacobs et al., 2010). However, there exist several difficulties. Neither antidepressants nor psychotherapy work fast enough for reduction of suicidal ideation.
Beside pharmacotherapy and psychotherapy brain stimulation methods have gained increasing relevance in the treatment of depression during the last decades (Baeken et al.,2019).
Repetitive transcranial magnetic stimulation (rTMS) therapy is a noninvasive neurostimulation treatment that has been adopted as a first-line treatment for pharmacotherapy-resistant major depressive disorder (MDD) (Milev et al., 2016).
Despite this growing evidence base supporting (iTBS) in the treatment of MDD, evidence for its efficacy in the treatment of suicidality as a primary outcome in both unipolar and bipolar depressive patients is still lacking.
Hypothesis We assume that accelerated TBS is effective in treatment of suicidality as well as depressive symptoms in both unipolar and bipolar patients.
Aim This study aims to reduce morbidity and mortality of unipolar and bipolar depressive patients and to improve overall functioning.
Objectives
- To investigate efficacy of accelerated TBS in suicidal reduction as primary outcome in patients with unipolar and bipolar depression.
- To compare efficacy of accelerated TBS in reduction of severity of depressive symptoms in unipolar and bipolar disorder as well as response and remission rates.
- To investigate association between the reduction of suicidality and the reduction of depressive symptoms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unipolar depressed patients with suicidality | Active comparator | Device: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark)The participants will receive iTBS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (LDLPFC) determined using Beam method for 1800 pulses with an intertreatment interval of fifty minutes. Stimulation was at 120% of resting motor threshold. Patients received ten sessions every day for five consecutive days for a total of fifty sessions (90,000 pulses). |
| Bipolar depressed patients with suicidality | Active comparator | Device: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark)The participants will receive iTBS (intermittent theta burst stimulation) to the left dorsolateral prefrontal cortex (LDLPFC) determined using Beam method for 1800 pulses with an intertreatment interval of fifty minutes. Stimulation was at 120% of resting motor threshold. Patients received ten sessions every day for five consecutive days for a total of fifty sessions (90,000 pulses). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of Major depressive episode as a part of MDD or bipolar (I or II) disorder and confirmed by Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I). (First \& Gibbon.,2004 ).
- Meeting the severe depression cutoff for MADRS (>/=35) at baseline visit.
- Meeting the severe depression cutoff for BDI-II (>/=30) at baseline visit.
- Presence of suicidal ideation and/or behavior (confirmed with Columbia Scale for the Rating of Suicide Severity (C-SSRS)
- Adults (Age 19 years or older )
Key exclusion criteria (10 listed)
- Current substance use disorder during the past 3 months
- Current psychotic disorder or symptoms
- Presence of dementia
- Presence of major medical illness, for example metastatic cancer, end stage renal disease
- Inability to verify contact information.
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 |
|---|---|---|
| Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark)TMS Therapy System with Theta Burst Stimulation | Device | Bipolar depressed patients with suicidality, Unipolar depressed patients with suicidality |
Primary outcome
Change in suicidal ideation and behaviors as measured by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month , 6 month, 9 month and 12 month
The SI severity scale is composed of five yes=no questions of increasingly severe suicidal thoughts: a wish to be dead (1), non-specific suicidal thoughts (2), suicidal thoughts with a method (3), suicidal intent without specific plan (4), and suicidal intent with specific plan (5). This scale was scored from 0 to 5 according to the most severe suicidal ideation endorsed. Higher scores mean worse outcome. Suicidal behaviors were assessed dichotomously (yes=no) and include actual suicide attempts, interrupted suicide attempts, aborted suicide attempts, other preparatory acts (e.g., collecting pills, writing suicide note), and non-suicidal self-injury (NSSI).
1 secondary outcome
Change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) Score
Time frame: Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month , 6 month ,9 months and 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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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.
Medhat M Bassiony, Professor principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark) in people with Suicide and Depression, run by Zagazig University at 1 site in Egypt.
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 10 inclusion and 10 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 4 Mar 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medhat M Bassiony, Professor (+201005334253, mbassiony@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in suicidal ideation and behaviors as measured by Columbia Suicide Severity Rating Scale (C-SSRS) (time frame: Assessed at baseline (day 0) , post-inpatient treatment completion (day 5) , 1 month ,3 month , 6 month, 9 month and 12 month). 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 4 Mar 2024.