Major Depressive Disorder study: Brain Scan
Official title The Impact of Working Memory and Reward Markers on DLPFC Activity in Treatment-resistant Depression
ClinicalTrials.gov ID: NCT06163625
What this study is testing
What is Saliva Samples?
an investigational biological sample collection being studied for Major Depressive Disorder
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Researchers want to see if changes in a brain area called the dorsolateral prefrontal cortex (DLPFC) and proteins in saliva predict how well rTMS helps people whose depression does not respond to medication or therapy.
- Who it's for
- Adults with major depressive disorder that has not improved with standard treatments.
- What's involved
- Participants will receive rTMS to the DLPFC, have brain scans before and after treatment, and give saliva samples for protein analysis. They will also complete questionnaires about their depression and history.
- Time commitment
- The study lasts several weeks of daily rTMS sessions, with multiple brain scans and saliva samples taken during the course of treatment.
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 65. Healthy volunteers may be eligible.
You may be able to join if
- Between the ages of 18 and 65 years old.
- Capable of giving voluntary and informed consent.
- Fluent in English.
- Meet Diagnostic and Statistical Manual criteria for single or recurrent Major Depressive Disorder (current major depressive episode), confirmed via...
- Moderate to severe depression severity, defined as a 17-item Hamilton Depression Rating Scale260 score ≥ 18.
You likely can't join if
- Are pregnant/lactating.
- Acute suicidality, defined as a score \>3 on the 17-item Hamilton Depression Rating Scale, Item #3.
- A MINI-confirmed diagnosis of bipolar disorder, or another comorbidity (e.g., obsessive-compulsive disorder, post-traumatic stress disorder) that is...
- Other major medical comorbidities requiring immediate investigation or treatment, cardiac pacemaker, or implanted medication pump.
- Lifetime history of psychosis, including schizophrenia, schizoaffective disorder, delusional disorder, or current psychotic symptoms.
- Drug abuse or dependence within the last 6 months, excluding caffeine and nicotine.
See the full eligibility criteria
- Between the ages of 18 and 65 years old.
- Capable of giving voluntary and informed consent.
- Fluent in English.
- Meet Diagnostic and Statistical Manual criteria for single or recurrent Major Depressive Disorder (current major depressive episode), confirmed via the Mini-International Neuropsychiatric Interview (MINI).
- Moderate to severe depression severity, defined as a 17-item Hamilton Depression Rating Scale260 score ≥ 18.
- Have failed to achieve a clinical response to an adequate dose of an antidepressant based in an Antidepressant Treatment History Form (ATHF) score ≥ 3 in the current episode, or have been unable to tolerate at least 2...
- Have had no initiation or dose change in any psychotropic medication in the four weeks prior to screening.
- If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic...
- Between the ages of 18 and 65 years old.
- Capable of giving voluntary and informed consent.
- Fluent in English.
- No current or previous history of psychiatric diagnoses.
- Absent/non-clinical depression severity, defined as a 17-item Hamilton Depression Rating Scale260 \< 8.
- No history of antidepressant use, as measured by the ATHF.
- Are pregnant/lactating.
- Acute suicidality, defined as a score \>3 on the 17-item Hamilton Depression Rating Scale, Item #3.
- A MINI-confirmed diagnosis of bipolar disorder, or another comorbidity (e.g., obsessive-compulsive disorder, post-traumatic stress disorder) that is primary in severity and disability relative to their MDD.
- Other major medical comorbidities requiring immediate investigation or treatment, cardiac pacemaker, or implanted medication pump.
- Lifetime history of psychosis, including schizophrenia, schizoaffective disorder, delusional disorder, or current psychotic symptoms.
- Drug abuse or dependence within the last 6 months, excluding caffeine and nicotine.
- Contraindication to receiving the rTMS (e.g. history of seizure, cochlear implants, benzodiazepine use (lorazepam or equivalent daily dose \>2mg daily), cardiac pacemaker, implanted neurostimulator, significant head...
- Electroconvulsive therapy (ECT) within the current depressive episode.
- Presence of contraindications for MRI, including metallic implants.
- Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except...
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.