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Compares treatment options for Suicidal Ideation
Official title Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI
ClinicalTrials.gov ID: NCT05377177
What this study is testing
- What it's testing
- This is a prospective clinical trial to confirm the effectiveness of bilateral accelerated theta burst stimulation (aTBS) on suicidal ideation (SI), while exploring cortical inhibition measures in this treatment paradigm. In this proposed study, the investigators will evaluate the anti-suicidal effects of bilateral aTBS over the DLPFC compared to accelerated intermittent theta burst stimulation (aiTBS) over the left DLPFC in participants with TRD and SI.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 18-70 years old.
- Diagnosis of major depressive episode, confirmed on Mini-International Neuropsychiatric Interview (MINI), with HRSD score ≥18.
- Ongoing SI present beyond screening phase of study (confirmed with Beck SSI score ≥4).
- Pass the TMS adult safety screening (TASS) questionnaire and the MRI safety screening questionnaire.
- Have failed to achieve a clinical response to an adequate dose of two antidepressants based on an Antidepressant Treatment History Form (ATHF) score...
You likely can't join if
- Have a confirmed diagnosis of substance use disorder within the last 3 months.
- Have a lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or...
- Have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized...
- Have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD.
- Have SI prompting emergent involuntary hospital stay (SI in which the participant can maintain voluntary and capable outpatient status as well as...
- Currently pregnant or lactating, or woman or childbearing age without adequate birth control.
See the full eligibility criteria
- 18-70 years old.
- Diagnosis of major depressive episode, confirmed on Mini-International Neuropsychiatric Interview (MINI), with HRSD score ≥18.
- Ongoing SI present beyond screening phase of study (confirmed with Beck SSI score ≥4).
- Pass the TMS adult safety screening (TASS) questionnaire and the MRI safety screening questionnaire.
- Have failed to achieve a clinical response to an adequate dose of two antidepressants based on an Antidepressant Treatment History Form (ATHF) score for each antidepressant trial of \> 3 in the current episode OR have...
- Psychiatric illness due to a general medical condition (GMC) has been ruled out during initial assessment.
- Voluntary outpatients capable to consent to treatment and seen at the UC San Diego Health treatment Psychiatry program.
- Able to adhere to the treatment schedule.
- Have a confirmed diagnosis of substance use disorder within the last 3 months.
- Have a lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
- Have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or...
- Have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD.
- Have SI prompting emergent involuntary hospital stay (SI in which the participant can maintain voluntary and capable outpatient status as well as recent suicide attempt will not be exclusionary).
- Currently pregnant or lactating, or woman or childbearing age without adequate birth control.
- Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
- Not capable to consent to treatment and/or not suitable for outpatient treatment.
- Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump; Have any significant neurological disorder or insult including, but not limited to: any condition likely to be...
- Currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS how well it works.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.