Stratified Pharmacological Approaches for Regulating Circuit-Level Effects
NCT ID: NCT07022405
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-08-31
2030-08-31
Brief Summary
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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.
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Detailed Description
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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.
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pramipexole Treatment Arm
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.
Pramipexole Immediate Release
The intervention involves taking pramipexole immediate release (IR) for 8 weeks followed by 2 weeks of down titration and follow up.
Interventions
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Pramipexole Immediate Release
The intervention involves taking pramipexole immediate release (IR) for 8 weeks followed by 2 weeks of down titration and follow up.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Stanford University
OTHER
Responsible Party
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Leanne Williams
Professor of Psychiatry and Behavioral Sciences
Locations
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Stanford University
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Sporn J, Ghaemi SN, Sambur MR, Rankin MA, Recht J, Sachs GS, Rosenbaum JF, Fava M. Pramipexole augmentation in the treatment of unipolar and bipolar depression: a retrospective chart review. Ann Clin Psychiatry. 2000 Sep;12(3):137-40. doi: 10.1023/a:1009060800999.
Goldberg JF, Burdick KE, Endick CJ. Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment-resistant bipolar depression. Am J Psychiatry. 2004 Mar;161(3):564-6. doi: 10.1176/appi.ajp.161.3.564.
Lattanzi L, Dell'Osso L, Cassano P, Pini S, Rucci P, Houck PR, Gemignani A, Battistini G, Bassi A, Abelli M, Cassano GB. Pramipexole in treatment-resistant depression: a 16-week naturalistic study. Bipolar Disord. 2002 Oct;4(5):307-14. doi: 10.1034/j.1399-5618.2002.01171.x.
Inoue T, Kitaichi Y, Masui T, Nakagawa S, Boku S, Tanaka T, Suzuki K, Nakato Y, Usui R, Koyama T. Pramipexole for stage 2 treatment-resistant major depression: an open study. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Dec 1;34(8):1446-9. doi: 10.1016/j.pnpbp.2010.07.035. Epub 2010 Aug 11.
Hori H, Kunugi H. The efficacy of pramipexole, a dopamine receptor agonist, as an adjunctive treatment in treatment-resistant depression: an open-label trial. ScientificWorldJournal. 2012;2012:372474. doi: 10.1100/2012/372474. Epub 2012 Aug 1.
Dell'Osso B, Ketter TA. Assessing efficacy/effectiveness and safety/tolerability profiles of adjunctive pramipexole in bipolar depression: acute versus long-term data. Int Clin Psychopharmacol. 2013 Nov;28(6):297-304. doi: 10.1097/YIC.0b013e3283639015.
Strejilevich SA, Martino DJ, Igoa A, Manes F. Pathological gambling in a bipolar patient treated with pramipexole. J Neuropsychiatry Clin Neurosci. 2011 Winter;23(1):E2-3. doi: 10.1176/jnp.23.1.jnpe2. No abstract available.
El-Mallakh RS, Penagaluri P, Kantamneni A, Gao Y, Roberts RJ. Long-term use of pramipexole in bipolar depression: a naturalistic retrospective chart review. Psychiatr Q. 2010 Sep;81(3):207-13. doi: 10.1007/s11126-010-9130-6.
Cassano P, Lattanzi L, Soldani F, Navari S, Battistini G, Gemignani A, Cassano GB. Pramipexole in treatment-resistant depression: an extended follow-up. Depress Anxiety. 2004;20(3):131-8. doi: 10.1002/da.20038.
Takahashi M, Nishida S, Nakamura M, Kobayashi M, Matsui K, Ito E, Usui A, Inoue Y. Restless legs syndrome augmentation among Japanese patients receiving pramipexole therapy: Rate and risk factors in a retrospective study. PLoS One. 2017 Mar 6;12(3):e0173535. doi: 10.1371/journal.pone.0173535. eCollection 2017.
Perugi G, Toni C, Ruffolo G, Frare F, Akiskal H. Adjunctive dopamine agonists in treatment-resistant bipolar II depression: an open case series. Pharmacopsychiatry. 2001 Jul;34(4):137-41. doi: 10.1055/s-2001-15872.
Aiken CB. Pramipexole in psychiatry: a systematic review of the literature. J Clin Psychiatry. 2007 Aug;68(8):1230-6.
Zarate CA Jr, Payne JL, Singh J, Quiroz JA, Luckenbaugh DA, Denicoff KD, Charney DS, Manji HK. Pramipexole for bipolar II depression: a placebo-controlled proof of concept study. Biol Psychiatry. 2004 Jul 1;56(1):54-60. doi: 10.1016/j.biopsych.2004.03.013.
Corrigan MH, Denahan AQ, Wright CE, Ragual RJ, Evans DL. Comparison of pramipexole, fluoxetine, and placebo in patients with major depression. Depress Anxiety. 2000;11(2):58-65. doi: 10.1002/(sici)1520-6394(2000)11:23.0.co;2-h.
Chaudhuri KR, Rizos A, Sethi KD. Motor and nonmotor complications in Parkinson's disease: an argument for continuous drug delivery? J Neural Transm (Vienna). 2013 Sep;120(9):1305-20. doi: 10.1007/s00702-013-0981-5. Epub 2013 Mar 2.
Drijgers RL, Verhey FR, Tissingh G, van Domburg PH, Aalten P, Leentjens AF. The role of the dopaminergic system in mood, motivation and cognition in Parkinson's disease: a double blind randomized placebo-controlled experimental challenge with pramipexole and methylphenidate. J Neurol Sci. 2012 Sep 15;320(1-2):121-6. doi: 10.1016/j.jns.2012.07.015. Epub 2012 Jul 22.
Miura S, Kida H, Nakajima J, Noda K, Nagasato K, Ayabe M, Aizawa H, Hauser M, Taniwaki T. Anhedonia in Japanese patients with Parkinson's disease: analysis using the Snaith-Hamilton Pleasure Scale. Clin Neurol Neurosurg. 2012 May;114(4):352-5. doi: 10.1016/j.clineuro.2011.11.008. Epub 2011 Dec 2.
Fujiwara S, Kimura F, Hosokawa T, Ishida S, Sugino M, Hanafusa T. Anhedonia in Japanese patients with Parkinson's disease. Geriatr Gerontol Int. 2011 Jul;11(3):275-81. doi: 10.1111/j.1447-0594.2010.00678.x. Epub 2011 Jan 17.
Hamidovic A, Kang UJ, de Wit H. Effects of low to moderate acute doses of pramipexole on impulsivity and cognition in healthy volunteers. J Clin Psychopharmacol. 2008 Feb;28(1):45-51. doi: 10.1097/jcp.0b013e3181602fab.
Lemke MR, Brecht HM, Koester J, Kraus PH, Reichmann H. Anhedonia, depression, and motor functioning in Parkinson's disease during treatment with pramipexole. J Neuropsychiatry Clin Neurosci. 2005 Spring;17(2):214-20. doi: 10.1176/jnp.17.2.214.
Reichmann H, Brecht MH, Koster J, Kraus PH, Lemke MR. Pramipexole in routine clinical practice: a prospective observational trial in Parkinson's disease. CNS Drugs. 2003;17(13):965-73. doi: 10.2165/00023210-200317130-00003.
Fawcett J, Rush AJ, Vukelich J, Diaz SH, Dunklee L, Romo P, Yarns BC, Escalona R. Clinical Experience With High-Dosage Pramipexole in Patients With Treatment-Resistant Depressive Episodes in Unipolar and Bipolar Depression. Am J Psychiatry. 2016 Feb 1;173(2):107-11. doi: 10.1176/appi.ajp.2015.15060788. No abstract available.
Other Identifiers
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80975
Identifier Type: -
Identifier Source: org_study_id
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