Pramipexole in treatment-resistant depression: a 16-week naturalistic study.

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.

[1]  M. Fava,et al.  Pramipexole Augmentation in the Treatment of Unipolar and Bipolar Depression: A Retrospective Chart Review , 2000, Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists.

[2]  M. Fava.  New approaches to the treatment of refractory depression. , 2000, The Journal of clinical psychiatry.

[3]  Dwight L. Evans,et al.  Comparison of pramipexole, fluoxetine, and placebo in patients with major depression , 2000, Depression and anxiety.

[4]  S. Pallanti,et al.  Effectiveness of olanzapine treatment for severe obsessive-compulsive disorder. , 1999, The American journal of psychiatry.

[5]  M. Bauer,et al.  Lithium augmentation in treatment-resistant depression: meta-analysis of placebo-controlled studies. , 1999, Journal of clinical psychopharmacology.

[6]  M. Fava,et al.  Efficacy of fluvoxamine in the treatment of major depression with comorbid anxiety disorders. , 1999, The Journal of clinical psychiatry.

[7]  M. Frye,et al.  Pramipexole in refractory bipolar depression. , 1999, The American journal of psychiatry.

[8]  D. Dietrich,et al.  Possible Use of Amantadine in Depression , 1999, Pharmacopsychiatry.

[9]  C. Hammen,et al.  Bipolar depression and antidepressant-induced mania: a naturalistic study. , 1998, The Journal of clinical psychiatry.

[10]  F. Benazzi.  Antidepressant-associated hypomania in outpatient depression: a 203-case study in private practice. , 1997, Journal of affective disorders.

[11]  P. Willner.  The mesolimbic dopamine system as a target for rapid antidepressant action , 1997, International clinical psychopharmacology.

[12]  N. Andreasen.  Improvement of negative symptoms: concepts, definition and assessment , 1997, International clinical psychopharmacology.

[13]  J. Fawcett,et al.  Efficacy issues with antidepressants. , 1997, The Journal of clinical psychiatry.

[14]  G. Lenzi,et al.  Dopamine hypersensitivity in migraine: role of the apomorphine test. , 1997, Clinical neuropharmacology.

[15]  H. Volz,et al.  Pramipexole as adjunct to haloperidol in schizophrenia Safety and efficacy , 1996, European Neuropsychopharmacology.

[16]  W. Gaebel,et al.  Pramipexole, a Dopamine Agonist, in Major Depression: Antidepressant Effects and Tolerability in an Open‐Label Study with Multiple Doses , 1997 .

[17]  C. Naylor,et al.  Triiodothyronine augmentation in the treatment of refractory depression. A meta-analysis. , 1996, Archives of general psychiatry.

[18]  M. Fava,et al.  Definition and epidemiology of treatment-resistant depression. , 1996, The Psychiatric clinics of North America.

[19]  S D Imber,et al.  Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Application to the NIMH treatment of Depression Collaborative Research Program dataset. , 1993, Archives of general psychiatry.

[20]  A. Bouckoms,et al.  Pergolide: an antidepressant adjuvant for mood disorders? , 1993, Psychopharmacology bulletin.

[21]  H. Wetzel,et al.  Dopamine Autoreceptor Agonists in the Treatment of Schizophrenia and Major Depression* , 1992, Pharmacopsychiatry.

[22]  C. Garvey,et al.  Assessing psychotropic medication side effects among children. A reliability study. , 1991, Journal of child and adolescent psychiatric and mental health nursing.

[23]  H Wetzel,et al.  Improving depression severity assessment--I. Reliability, internal validity and sensitivity to change of three observer depression scales. , 1988, Journal of psychiatric research.

[24]  B. Walsh,et al.  Tricyclic nonresponders: phenomenology and treatment. , 1986, The American journal of psychiatry.