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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01MH136062-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole Immediate Release | Drug | The intervention involves taking pramipexole immediate release (IR) for 8 weeks followed by 2 weeks of down titration and follow up. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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"). | 8 weeks |
| Brain imaging | Non-invasive brain circuit quantification as assessed by functional magnetic resonance imaging metrics of activation and connectivity. | 8 weeks |
| Cognitive-Emotional Behavioral Assessment | WebNeuro is a computerized cognitive-emotional behavioral assessment designed to objectively measure cognitive and emotional function. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Wydler | Contact | (650)-736-4393 | iwydler@stanford.edu | |
| Daniella Evangelista | Contact | danevan@stanford.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 8 weeks |
| 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). | 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. | 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. | 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. | 8 weeks |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |