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New treatment option for Major Depressive Disorder (MDD)
Official title Theta-Burst Stimulation to Treat Depression
ClinicalTrials.gov ID: NCT07033780
What this study is testing
- What it's testing
- The goal of this clinical trial is to explore the effects of non-invasive brain stimulation protocols using intermittent theta-burst stimulation (iTBS) on brain plasticity and depression severity in depressed individuals aged 18 to 50 years old. Brain plasticity is the brain's ability to change through growth or reorganization.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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 50
You may be able to join if
- Aged 18-50 years old;
- Must meet criteria for a current Major Depressive Episode (MDE) as ascertained using the Structured Clinical Interview for DSM 5 (SCID-5);
- Hamilton Rating Scale for Depression (HRSD-17) score \> 7;
- Must be on a stable antidepressant regimen for a minimum of 4 weeks prior to enrollment, if currently taking antidepressants;
- Right handed or ambidextrous, assessed using the Edinburgh Handedness Inventory (EHI);
You likely can't join if
- Age 17 years or less, or greater than 51 years old, as brain plasticity is known to be affected by age;
- Presence of any DSM-5 diagnosis (other than MDD), known to be associated with prefrontal cortical dysfunction, including lifetime diagnoses of...
- Presence of acute suicidal intent, as determined by the Scale for Suicidal Ideation (SSI);
- Contradictions to MRI or TMS (e.g., cardiac pacemaker, acoustic device, history of seizures, pregnancy), assessed using the MRI Safety Form and TMS...
- Left handed, assessed using the EHI, to minimize the heterogeneity in cortical excitability and plasticity;
- Current antipsychotic, antiepileptic, or benzodiazepine use given their potential effects on cortical plasticity, as ascertained through a medication...
See the full eligibility criteria
- Aged 18-50 years old;
- Must meet criteria for a current Major Depressive Episode (MDE) as ascertained using the Structured Clinical Interview for DSM 5 (SCID-5);
- Hamilton Rating Scale for Depression (HRSD-17) score \> 7;
- Must be on a stable antidepressant regimen for a minimum of 4 weeks prior to enrollment, if currently taking antidepressants;
- Right handed or ambidextrous, assessed using the Edinburgh Handedness Inventory (EHI);
- Sufficiently proficient in English to complete the required study assessments, as per investigator judgement;
- Willingness and capacity to provide informed consent;
- Willingness to comply with all study procedures.
- Age 17 years or less, or greater than 51 years old, as brain plasticity is known to be affected by age;
- Presence of any DSM-5 diagnosis (other than MDD), known to be associated with prefrontal cortical dysfunction, including lifetime diagnoses of bipolar disorder, intellectual disability, or a psychotic disorder, assessed...
- Presence of acute suicidal intent, as determined by the Scale for Suicidal Ideation (SSI);
- Contradictions to MRI or TMS (e.g., cardiac pacemaker, acoustic device, history of seizures, pregnancy), assessed using the MRI Safety Form and TMS Adult Safety Screen (TASS) and as per investigator judgement;
- Left handed, assessed using the EHI, to minimize the heterogeneity in cortical excitability and plasticity;
- Current antipsychotic, antiepileptic, or benzodiazepine use given their potential effects on cortical plasticity, as ascertained through a medication review. An exception will be made if they are taking gabapentin or...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. 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.