Clinical trial NCT07022405: Stratified Pharmacological Approaches for Regulating Circuit-Level Effects
Official title: Stratified Pharmacological Approaches for Regulating Circuit-Level Effects Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Depression - Major Depressive Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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. We hope to learn which circuits are involved in depression and how these circuits interact with pramipexole to affect mood, behavior, and cognition.

Participants will undergo an 8-week treatment course of pramipexole followed by a 2-week down taper and follow up. Our 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 we gain from investigating the brain circuits involved in depression to help personalize treatment.

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

Detailed description: If you are eligible and choose to participate, we will ask you 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 you will undergo a non-invasive MRI brain scan, complete game-like tasks in the scanner, and answer questions about your 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, you 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 us to learn more about participating in this study.

Eligibility criteria: 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.
* fMRI scanning eligibility. All participants will need to successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI).
* PHQ-8 \>/= 10
* Meet DSM-5 diagnostic criteria for current or recurrent nonpsychotic 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 CA 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 ADHD
* Meeting DSM-5 criteria for current 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)

Primary outcomes:
measure: QIDS-SR: Quick Inventory of Depressive Symptomatology Self-Report
timeFrame: 8 weeks
measure: MASQ-30: Mood Anxiety Symptom Questionnaire
timeFrame: 8 weeks
measure: Brain imaging
timeFrame: 8 weeks
measure: Cognitive-Emotional Behavioral Assessment
timeFrame: 8 weeks
Secondary outcomes:
measure: DARS: Dimensional Anhedonia Rating Scale
timeFrame: 8 weeks
measure: PHQ-9: Patient Health Questionnaire-9
timeFrame: 8 weeks
measure: HAM-D-17: Hamilton Depression Rating Scale
timeFrame: 8 weeks
measure: SWLS: Satisfaction With Life Scale
timeFrame: 8 weeks
measure: WHOQoL-BREF: The World Health Organization Quality of Life - BREF
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
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