Depression - Major Depressive DisorderPhase 2SPARCLENCT07022405
Stratified Pharmacological Approaches for Regulating Circuit-Level Effects
A Phase 2 study testing Pramipexole Immediate Release in people with Depression - Major Depressive Disorder, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Pramipexole Immediate Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2026to Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daniella Evangelista contact
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305
Isabelle Wydler, 650-736-4393, iwydler@stanford.edu
Daniella Evangelista, danevan@stanford.edu
About this study
Official title: Stratified Pharmacological Approaches for Regulating Circuit-Level Effects Study
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.
Read the detailed 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.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Pramipexole Immediate Release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole Immediate ReleaseDrug
The intervention involves taking pramipexole immediate release (IR) for 8 weeks followed by 2 weeks of down titration and follow up.
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole Treatment Arm | Experimental | 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. Receives: Drug: Pramipexole Immediate Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
QIDS-SR: Quick Inventory of Depressive Symptomatology Self-Report
The QIDS-SR (Quick Inventory of Depressive Symptomatology - Self-Report) is a self-report questionnaire designed to assess the severity of depressive symptoms over the past seven days. It includes 16 items that evaluate 9 symptom domains corresponding to the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for major depressive disorder: sad mood, concentration difficulties, self-criticism or guilt, suicidal ideation, loss of interest, low energy or fatigue, sleep disturbances, changes in appetite or weight, and psychomotor agitation or retardation. Each domain is rated on a scale from 0 to 3, with total scores ranging from 0 to 27. Scores are interpreted as follows: 0-5 indicates no depression, 6-10 mild, 11-15 moderate, 16-20 severe, and 21-27 very severe depression. It is brief, taking approximately 5 to 10 minutes to complete.
Measured: 8 weeks
MASQ-30: Mood Anxiety Symptom Questionnaire
The MASQ-30 (Mood and Anxiety Symptom Questionnaire - 30-item version) is a self-report questionnaire designed to measure symptoms of depression and anxiety. It separate symptoms that are shared between depression and anxiety from those that are more specific to each condition. The MASQ-30 includes 30 questions, divided into three main areas: Anhedonic Depression, which looks at symptoms like loss of interest or pleasure; Anxious Arousal, which focuses on physical signs of anxiety such as restlessness or a racing heart; and General Distress, which captures overall emotional discomfort common to both depression and anxiety. Each question asks how much the person has experienced a particular symptom in the past week, using a scale from 1 ("not at all") to 5 ("extremely").
Measured: 8 weeks
Brain imaging
Non-invasive brain circuit quantification as assessed by functional magnetic resonance imaging metrics of activation and connectivity.
Measured: 8 weeks
Cognitive-Emotional Behavioral Assessment
WebNeuro is a computerized cognitive-emotional behavioral assessment designed to objectively measure cognitive and emotional function.
Measured: 8 weeks
Secondary outcomes (5)
DARS: Dimensional Anhedonia Rating Scale
The DARS (Dimensional Anhedonia Rating Scale) is a brief, self-report tool developed to assess anhedonia, the reduced ability to experience pleasure-a key symptom in depression and other psychiatric disorders. It evaluates four domains of reward-related functioning: hobbies, food/drink, social activities, and sensory experiences (e.g., music, nature). For each domain, individuals rate items across several dimensions: interest, motivation, effort, and pleasure. Responses are given on a 5-point Likert scale, typically ranging from 0 to 4, with higher scores indicating greater engagement or enjoyment.
The full scale includes 17 items, and the total score is calculated by summing the responses, with possible scores ranging from 0 to 68. Higher total scores reflect lower levels of anhedonia. Conversely, lower scores suggest greater anhedonia
Measured: 8 weeks
PHQ-9: Patient Health Questionnaire-9
The PHQ-9 (Patient Health Questionnaire-9) is a self-report screening tool designed to assess the presence and severity of depressive symptoms. It consists of 9 questions, each corresponding to one of the diagnostic criteria for major depressive disorder as outlined in the DSM. Respondents rate how often they have experienced each symptom over the past two weeks on a 4-point scale: 0 ("not at all"), 1 ("several days"), 2 ("more than half the days"), and 3 ("nearly every day"). The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. Scores are typically interpreted as follows: 0-4 (minimal depression), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe depression).
Measured: 8 weeks
HAM-D-17: Hamilton Depression Rating Scale
The HAM-D-17 (Hamilton Depression Rating Scale), also known as the HDRS, is a clinician-administered assessment used to evaluate the severity of depressive symptoms in individuals diagnosed with depression. Each item is rated based on a structured interview, focusing on symptoms such as depressed mood, insomnia, anxiety, appetite disturbance, and suicidal ideation. Most items are scored on a scale from 0 to 4 or 0 to 2, depending on the symptom, with the total score ranging from 0 to 52 in the 17-item version. Interpretation of scores is generally as follows: 0-7 is considered normal or in remission, 8-13 indicates mild depression, 14-18 moderate, 19-22 severe, and 23 or higher very severe depression.
Measured: 8 weeks
SWLS: Satisfaction With Life Scale
The Satisfaction With Life Scale (SWLS) is a brief, self-report questionnaire used to assess an individual's cognitive evaluation of life satisfaction. It consists of 5 items, each rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), resulting in a total score ranging from 5 to 35. Higher scores indicate greater life satisfaction. The SWLS does not assess specific domains (e.g., health or work) but instead provides a broad measure of perceived well-being.
Measured: 8 weeks
WHOQoL-BREF: The World Health Organization Quality of Life - BREF
The World Health Organization Quality of Life - BREF (WHOQOL-BREF) was developed by the World Health Organization to assess an individual's perceived quality of life. It includes 26 items that ask about a person's physical health, psychological well-being, social relationships, and environment. Each item is rated on a 5-point scale, with higher scores indicating a more positive perception of that area of life. The responses are grouped into four domain scores: Physical Health, Psychological Health, Social Relationships, and Environment. Scores for each domain are calculated and then transformed to a scale from 0 to 100, with higher scores reflecting better quality of life. The WHOQOL-BREF provides a broad yet efficient snapshot of how individuals feel about their overall well-being and daily functioning.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start23 Jan 2026
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Leanne Williams, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022405
- Sponsor's protocol ID
- 80975
- Other IDs
- 5U01MH136062-02
- Acronym
- SPARCLE
- Status last verified
- May 2026
- First submitted
- 6 Jun 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratified Pharmacological Approaches for Regulating Circuit-Level Effects Study
- ClinicalTrials.gov ID
- NCT07022405
- Acronym / sponsor ID
- SPARCLE / 80975
- Conditions
- Depression - Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pramipexole Treatment Arm | Experimental | Drug: Pramipexole Immediate ReleaseThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pramipexole Immediate ReleaseThe intervention involves taking pramipexole immediate release (IR) for 8 weeks followed by 2 weeks of down titration and follow up. | Drug | Pramipexole Treatment Arm |
Primary outcome
QIDS-SR: Quick Inventory of Depressive Symptomatology Self-Report
Time frame: 8 weeks
The QIDS-SR (Quick Inventory of Depressive Symptomatology - Self-Report) is a self-report questionnaire designed to assess the severity of depressive symptoms over the past seven days. It includes 16 items that evaluate 9 symptom domains corresponding to the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for major depressive disorder: sad mood, concentration difficulties, self-criticism or guilt, suicidal ideation, loss of interest, low energy or fatigue, sleep disturbances, changes in appetite or weight, and psychomotor agitation or retardation. Each domain is rated on a scale from 0 to 3, with total scores ranging from 0 to 27. Scores are interpreted as follows: 0-5 indicates no depression, 6-10 mild, 11-15 moderate, 16-20 severe, and 21-27 very severe depression. It is brief, taking approximately 5 to 10 minutes to complete.
MASQ-30: Mood Anxiety Symptom Questionnaire
Time frame: 8 weeks
The MASQ-30 (Mood and Anxiety Symptom Questionnaire - 30-item version) is a self-report questionnaire designed to measure symptoms of depression and anxiety. It separate symptoms that are shared between depression and anxiety from those that are more specific to each condition. The MASQ-30 includes 30 questions, divided into three main areas: Anhedonic Depression, which looks at symptoms like loss of interest or pleasure; Anxious Arousal, which focuses on physical signs of anxiety such as restlessness or a racing heart; and General Distress, which captures overall emotional discomfort common to both depression and anxiety. Each question asks how much the person has experienced a particular symptom in the past week, using a scale from 1 ("not at all") to 5 ("extremely").
Brain imaging
Time frame: 8 weeks
Non-invasive brain circuit quantification as assessed by functional magnetic resonance imaging metrics of activation and connectivity.
Cognitive-Emotional Behavioral Assessment
Time frame: 8 weeks
WebNeuro is a computerized cognitive-emotional behavioral assessment designed to objectively measure cognitive and emotional function.
5 secondary outcomes
DARS: Dimensional Anhedonia Rating Scale
Time frame: 8 weeks
PHQ-9: Patient Health Questionnaire-9
Time frame: 8 weeks
HAM-D-17: Hamilton Depression Rating Scale
Time frame: 8 weeks
SWLS: Satisfaction With Life Scale
Time frame: 8 weeks
WHOQoL-BREF: The World Health Organization Quality of Life - BREF
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniella Evangelista contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pramipexole Immediate Release in people with Depression - Major Depressive Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Wydler ((650)-736-4393, iwydler@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QIDS-SR: Quick Inventory of Depressive Symptomatology Self-Report (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.