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Biol Psychiatry. 2004 Jul 1;56(1):54-60. : Pramipexole for bipolar II depression: a placebo-controlled proof of concept study.
Zarate CA Jr, Payne JL, Singh J, Quiroz JA, Luckenbaugh DA, Denicoff KD, Charney DS, Manji HK.
Laboratory of Molecular Pathophysiology, Mood and Anxiety Disorders Program, National Institute of Mental Health, National Institute of Health, Department of Human and Health Services, Bethesda, Maryland, USA
BACKGROUND: The original serotonergic and noradrenergic hypotheses do not fully account for the neurobiology of depression or mechanism of action of effective antidepressants. Research implicates a potential role of the dopaminergic system in the pathophysiology of bipolar disorder. The current study was undertaken as a proof of the concept that dopamine agonists will be effective in patients with bipolar II depression. METHODS: In a double-blind, placebo-controlled study, 21 patients with DSM-IV bipolar II disorder, depressive phase on therapeutic levels of lithium or valproate were randomly assigned to treatment with pramipexole (n = 10) or placebo (n = 11) for 6 weeks. Primary efficacy was assessed by the Montgomery-Asberg Depression Rating Scale. RESULTS: All subjects except for one in each group completed the study. The analysis of variance for total Montgomery-Asberg Depression Rating Scale scores showed a significant treatment effect. A therapeutic response (>50% decrease in Montgomery-Asberg Depression Rating Scale from baseline) occurred in 60% of patients taking pramipexole and 9% taking placebo (p =.02). One subject on pramipexole and two on placebo developed hypomanic symptoms. CONCLUSIONS: The dopamine agonist pramipexole was found to have significant antidepressant effects in patients with bipolar II depression
Pramipexole shows bipolar antidepressant effect
Am J Psychiatry 2004; 161: 564-566
The addition of the dopamine agonist pramipexole to mood stabilizers could enhance the treatment response of patients with bipolar depression who have not previously responded to therapy, data from a preliminary US trial show.
Recognizing that dopamine agonists "have gained increasing attention for their possible antidepressant effects," Joseph Goldberg, from The Zucker Hillside Hospital in Glen Oaks, New York, and colleagues assessed the effect of pramipexole in depressed outpatients with non-psychotic bipolar disorder.
Twenty-two such patients were randomly assigned to receive placebo or flexibly dosed pramipexole, at an average maximum dose of 1.7 mg/day, in addition to their existing mood stabilizers.
In all, 10 (83%) of the 12 patients given pramipexole completed the 6 weeks of treatment, compared with just six (60%) of the 10 patients treated with placebo.
Notably, 57% of patients taking pramipexole achieved a 50% or greater reduction in depressive symptoms, as measured on the Hamilton Depression Rating Scale, compared with just 20% of those given placebo. Indeed, the average reduction in HAMD scores was 48% for patients taking pramipexole versus 21% for placebo-treated individuals.
Superior improvements in Clinical Global Impression scores were also seen for patients treated with pramipexole in comparison with placebo, with average scores of 2.7 and 4.4, respectively.
The drug was generally well tolerated, with no patients discontinuing treatment because of unwanted effects, although one patient did become hypomanic during the sixth week of treatment, despite taking concomitant divalproex.
Reporting in the American Journal of Psychiatry, the researchers conclude: "Pramipexole was a safe and effective antidepressant among patients with bipolar depression."
They add that larger randomized, controlled trials are warranted to confirm their initial observations.
  • 1: Bipolar Disord. 2002 Oct;4(5):307-14. :
    Pramipexole in treatment-resistant depression: a 16-week naturalistic study.
    Lattanzi L, Dell'Osso L, Cassano P, Pini S, Rucci P, Houck PR, Gemignani A, Battistini G, Bassi A, Abelli M, Cassano GB.
    Department of Psychiatry, Neurobiology, Pharmacology and Biotechnologies, University of Pisa, Italy.
    paolo.cassano@psico.med.unipi.it
    OBJECTIVE: To assess the antidepressant efficacy and tolerability of adjunctive pramipexole, a D2-D3 dopamine agonist, in patients with drug-resistant depression. METHODS: The study sample consisted of in-patients with major depressive episode, according to the DSM-IV, and drug resistance. Pramipexole was added to antidepressant treatment with TCA or SSRI, at increasing doses from 0.375 to 1.0 mg/day. Two independent response criteria were adopted: a > 50% reduction of the Montgomery-Asberg Depressive Rating Scale (MADRS) total score and a score of I or 2 on the Clinical Global Impression scale (CGI-1) at endpoint. Side-effects were assessed by the Dosage Record Treatment Emergent Symptom Scale (DOTES). RESULTS: Thirty-seven patients were enrolled. Of these. 16 had unipolar depression and 21 had bipolar depression. Six patients dropped out in the first week. Of the 31 patients included in the analyses. 19 completed the 16-week follow-up. Mean maximal dose of pramipexole was 0.95 mg/day. Mean scores on MADRS decreased from 33.3 +/- 8.4 at baseline to 13.9 +/- 11.5 at endpoint (p < 0.001) and the CGI-S decreased from 4.6 +/- 0.8 at baseline to 2.8 +/- 1.3 at endpoint (p < 0.001). At endpoint, 67.7% (21/31) of patients were responders on MADRS and 74.2% on CGI-I. Of the 37 patients enrolled, 10 discontinued pramipexole because of adverse events. CONCLUSIONS: These preliminary data suggest that pramipexole adjunction to antidepressant treatment may be effective and well tolerated in patients with resistant major depression.

    University of Pittsburgh Medical Center

    Bipolar disorder linked to specific brain regions; Certain drugs alter brain metabolism

    PITTSBURGH, June 17

    Late-breaking research, including a study that identifies the specific regions of the brain that may be responsible for manic behaviors, will be presented in a special session at the Sixth International Conference on Bipolar Disorder, held June 16 to 18 at the David L. Lawrence Convention Center in Pittsburgh.

    The special session includes 12 presentations that specifically focus on the most recent and promising research developments that are of interest to the more than 1,000 participants attending the only scientific meeting devoted exclusively to bipolar disorder research.

    Highlights of the twelve "rapid communications" presentations include the following three:

    I. CHILDHOOD GAME OF "RED LIGHT, GREEN LIGHT" ADAPTED TO STUDY BRAIN NETWORK IN BIPOLAR PATIENTS

    Bipolar disorder is widely associated with behaviors including elation, hyperactivity and impulsive, often reckless behaviors during patients' manic phases. But the specifics about what in the brain actually causes these behaviors are still unclear. Researcher Stephen Strakowski, M.D., of the University of Cincinnati College of Medicine examined brain activity in response to an impulse control task that showed manic bipolar patients may have difficulties modulating the brain regions that monitor task performance, namely, those regions that detect error and promote accurate responses.

    Dr. Strakowski noticed such difficulties in studies that used functional magnetic resonance imaging (fMRI), which is useful in mapping changes in the brain that correspond to mental operations. Both manic bipolar patients and healthy subjects were fitted with special goggles through which they viewed random blue letters and occasional targets, indicated by a blue letter X. Subjects were instructed to respond to the blue letter X targets by pressing a button. However, when the letter X turned from blue to red, they were asked to refrain from pressing the button.

    II. STUDY FINDS TWO DRUGS NECESSARY TO TREAT BIPOLAR'S PHASES While mood stabilizers and antipsychotics are essential for the treatment of bipolar disorder, both the complex nature of this illness and medication side effects pose problems for achieving an effective long-term maintenance therapy.

    Researcher Allan Young, Ph.D., and colleagues from the University of Newcastle in Newcastle-upon-Tyne in the United Kingdom, finds that no single medication licensed in either the United States or the U.K. for the treatment of bipolar disorder is effective for treating both the depressive phase and the manic phase of this illness.

    Dr. Young's analysis is the first to include all commonly used bipolar medications, with results suggesting the need for a two-pronged pharmacologic approach of both a mood stabilizer and an antipsychotic in order to prevent both depressive and manic recurrences. III. ALTERATION IN BRAIN CHEMICAL MAY PROVIDE CLUES INTO CAUSES OF BIPOLAR DISORDER AND LEAD TO NOVEL TREATMENTS

    Preliminary research has suggested that during the depressive phase, bipolar II patients have abnormally elevated metabolism, or activity, in specific regions of the brain, providing clues into the causes of the disease and suggesting novel treatment approaches. Bipolar disorder II is characterized by episodes of less severe mania, called hypomania, and major depression.

    Using PET imaging, researcher Carlos Zarate, M.D., of the National Institute of Mental Health, studied the brains of patients with bipolar II depression before their symptoms emerged, and repeated the studies after the patients had received a six-week course of the antidepressant pramipexole, a drug that increases neurotransmitter activity by stimulating dopamine receptors.

    Compared to patients who received placebo, pramipexole resulted in decreased brain activity in certain regions that in earlier scans had shown high activity, as well as decreased depression and anxiety symptoms. In contrast, pramipexole treatment did not alter metabolism in other brain regions, such as the amygdala, that have been implicated with conventional antidepressants but instead, pramipexole was found to increase activity in the premotor cortex, hippocampus, posterior cingulate cortex, and superior temporal gyrus.

    The Sixth International Conference on Bipolar Disorder is being presented by the University of Pittsburgh School of Medicine and Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center.