Stratified Pharmacological Approaches for Regulating Circuit-Level Effects (SPARCLE)

Stanford University

Status and phase: Not yet enrolling; Phase 2

Conditions: Depression - Major Depressive Disorder

Treatments: Drug: Pramipexole Immediate Release

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07022405

80975

5U01MH136062-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Eligible participants will undergo an 8-week treatment course of pramipexole followed by a 2-week down taper and follow up. The ultimate goal is to offer people experiencing depression a medication that is alternative to ones that may not have worked in the past and to apply the knowledge the investigators gain from investigating the brain circuits involved in depression to help personalize treatment.

The investigators invite anyone who has recently experienced symptoms of depression to participate. A prior diagnosis of depression is not required.

Full description

Participants will be asked to attend up to two in-person testing visits and commit to 10 weeks of treatment and remote participation.

The in-person testing visit at the beginning of the study lasts up to 4 hours. During this visit participants will undergo a non-invasive functional magnetic resonance imaging (fMRI) brain scan, complete game-like tasks in the scanner, and answer questions regarding emotional health.

Treatment involves an 8-week course of pramipexole and followed by a 2-week down taper and follow-up. During this 10-week period, participants will meet remotely with a study coordinator or study clinician each week to answer questions about medication side effects and emotional health and to complete online surveys to monitor mood.

Sign up online or contact the investigators to learn more about participating in this study.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion 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 Interview (MINI)

Exclusion criteria

• 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 under the supervision of either their usual clinician or the study clinician. A washout period of 5 half-lives-or a different duration as determined by the study clinician-must be completed before the first scan.)
• Concurrent participation in other intervention or treatment studies
• Not having a current primary care or psychiatric provider (seen within the past year)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Pramipexole Treatment Arm

Experimental group

Description:

The investigators will ask eligible participants to attend up to 2 in-person testing visits and commit to 10 weeks of treatment and remote participation. The in-person testing visit at the beginning of the study lasts up to 4 hours. During this visit participants will undergo a non-invasive functional magnetic resonance imaging (fMRI) brain scan, complete game-like tasks in the scanner, and answer questions regarding emotional health. Treatment involves an 8-week course of pramipexole and followed by a 2-week down titration and follow up. During this 10-week period, participants will meet remotely with a study coordinator or study clinician each week to answer questions about medication side effects and emotional health and to complete online surveys to monitor mood.

Treatment:

Drug: Pramipexole Immediate Release