BridgeMD
New treatment option for Major Depressive Disorder
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?
Saliva Samples is an investigational medicine, being studied as a potential treatment 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
- Major Depressive Disorder (MDD) is a very common illness that is usually treated with antidepressant medication. Depression can be caused by many things such as childhood experiences, genetics, and changes in the way the body and brain function.
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
- Depressed Participants:
- 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...
You likely can't join if
- All Participants:
- 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.
See the full eligibility criteria
- Depressed Participants:
- 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...
- Can adhere to the study schedule. Nondepressed Participants:
- 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.
- All Participants:
- 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'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 65 years. Healthy volunteers may be eligible. 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.