BridgeMD
New treatment option for Depression - Major Depressive Disorder
Official title Stratified Pharmacological Approaches for Regulating Circuit-Level Effects
ClinicalTrials.gov ID: NCT07022405
What this study is testing
What is Pramipexole Immediate Release?
Pramipexole Immediate Release is an investigational medicine, being studied as a potential treatment for depression - 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
- This research study aims to understand how people with depression respond to the medication pramipexole and to determine whether clinical response differs depending on the function of specific circuits in the brain. The investigators hope to learn which circuits are involved in depression and how these circuits interact with pramipexole to affect mood, behavior, and cognition.
- Phase 2: a mid-size study of how well it works
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
You may be able to join if
- 18-65 years old (inclusive)
- Fluent and literate in English, with non-impaired intellectual abilities to ensure adequate comprehension of the task instructions.
- Willing to provide written, informed consent.
- Functional magnetic resonance imaging (fMRI) scanning eligibility. All participants will need to successfully complete the screening forms at the...
- Patient Health Questionnaire-8 (PHQ-8) \>/= 10
You likely can't join if
- Suicidality with active plan or as determined clinician judgment
- Current or lifetime history of medical illness or brain injury that may interfere with assessments as determined by clinician judgment
- Severe impediment to vision, hearing, and/or hand movement likely to interfere with ability to complete the assessments, or is unable and/or unlikely...
- Pregnant, breastfeeding or unwilling or unable to use adequate birth control throughout the study
- History of non-responsive depression to dopamine agonists
- Any contraindication to being scanned in the 3.0T fMRI scanner, such as a cardiac pacemaker or implanted device that has not been cleared for scanning
See the full eligibility criteria
- 18-65 years old (inclusive)
- Fluent and literate in English, with non-impaired intellectual abilities to ensure adequate comprehension of the task instructions.
- Willing to provide written, informed consent.
- Functional magnetic resonance imaging (fMRI) scanning eligibility. All participants will need to successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI).
- Patient Health Questionnaire-8 (PHQ-8) \>/= 10
- Meet the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for current or recurrent nonpsychotic Major Depressive Disorder (MDD) established by the Mini International Neuropsychiatric...
- Suicidality with active plan or as determined clinician judgment
- Current or lifetime history of medical illness or brain injury that may interfere with assessments as determined by clinician judgment
- Severe impediment to vision, hearing, and/or hand movement likely to interfere with ability to complete the assessments, or is unable and/or unlikely to follow the study protocols as determined by clinician judgment
- Pregnant, breastfeeding or unwilling or unable to use adequate birth control throughout the study
- History of non-responsive depression to dopamine agonists
- Any contraindication to being scanned in the 3.0T fMRI scanner, such as a cardiac pacemaker or implanted device that has not been cleared for scanning
- Previous or current DSM-5 bipolar disorder (I, II, not otherwise specified), schizophrenia spectrum or other psychotic disorders, or psychosis or as determined by clinician judgment
- Previous or current diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
- Meeting DSM-5 criteria for current Obsessive-Compulsive Disorder (OCD) or eating disorder
- Meeting DSM-5 criteria for alcohol use disorder or substance use disorder within the last 12 months
- Clinically significant presence/history of impulsive-compulsive behaviors or control disorder including but not limited to gambling disorder within the last 12 months.
- Current use or use of psychotropic medication within the past month. (If the participant's usual treating clinician agrees with discontinuing the medication, participants may enroll after tapering off the medication...
- Concurrent participation in other intervention or treatment studies
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, 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.