Cassano Paolo, Lattanzi Lorenzo, Soldani Federico, Navari Serena, Battistini Giulia, Gemignani Alfredo, Cassano Giovanni Battista
Department of Psychiatry, Neurobiology, Pharmacology and Biotechnology, University of Pisa, Pisa, Italy.
Depress Anxiety. 2004;20(3):131-8. doi: 10.1002/da.20038.
We evaluated the long-term antidepressant safety and response of adjunctive pramipexole, a D2-D3 dopamine agonist, in the course of drug-resistant depression. Twenty-three patients with treatment-resistant major depressive episode (MDE) were followed up after a 16-week pramipexole add-on trial. Pramipexole was added to current treatment with TCA or SSRI, at increasing doses from 0.375-1.500 mg/day. The LIFE scale was administered at baseline of the acute trial, at Weeks 16, 32, and 48. Patients were analyzed for sustained remission (score= <2 at LIFE for at least 8 weeks) and recurrence (after remission score > =3 at LIFE for at least 2 weeks) of depression. Of 23 patients, 12 had major depression and 11 had bipolar depression (16 women; mean age=52.8 years). Mean age of onset and median duration of current MDE were 35.1 years and 6 months, respectively; all subjects had at least two prior MDEs. Mean pramipexole dose was 0.990 mg/day. Median duration of follow-up was 28 weeks. Mean baseline MADRS and CGI-S scores were 33.7+/-8.4 (sd) and 4.6+/-0.8, respectively. Median time to sustained remission from baseline was 10 weeks and overall 60.9% (14/23) of subjects recovered within Week 22. Recurrence of depression occurred in 35.7% (5/14) of remitters after Week 24 and within Week 28 from remission. Although there were no sleep attacks, two cases of hypomania and one case of psychotic mania occurred at Weeks 22, 24, and 30, respectively. Pramipexole augmentation of antidepressant treatment was relatively safe and presumably effective in the long-term course of treatment resistant depression.
我们评估了D2-D3多巴胺激动剂普拉克索作为辅助用药在难治性抑郁症病程中的长期抗抑郁安全性及疗效。在一项为期16周的普拉克索添加试验后，对23例难治性重度抑郁发作（MDE）患者进行了随访。普拉克索以0.375-1.500mg/天的递增剂量添加到当前的三环类抗抑郁药（TCA）或选择性5-羟色胺再摄取抑制剂（SSRI）治疗中。在急性试验的基线、第16周、第32周和第48周使用LIFE量表进行评估。分析患者抑郁症的持续缓解情况（LIFE评分<2分至少持续8周）和复发情况（缓解后LIFE评分>=3分至少持续2周）。23例患者中，12例为重度抑郁症，11例为双相抑郁症（16名女性；平均年龄52.8岁）。当前MDE的平均发病年龄和中位病程分别为35.1岁和6个月；所有受试者既往至少有两次MDE发作。普拉克索的平均剂量为0.990mg/天。中位随访时间为28周。平均基线蒙哥马利-艾森伯格抑郁量表（MADRS）和临床总体印象量表严重程度（CGI-S）评分分别为33.7±8.4（标准差）和4.6±0.8。从基线到持续缓解的中位时间为10周，总体上60.9%（14/23）的受试者在第22周内康复。24周后，35.7%（5/14）的缓解者出现抑郁症复发，复发发生在缓解后的第28周内。虽然没有出现睡眠发作，但分别在第22周、第24周和第30周发生了2例轻躁狂和1例精神病性躁狂。在难治性抑郁症的长期治疗过程中，普拉克索增强抗抑郁治疗相对安全且可能有效。
