Grunze Heinz, Langosch Jens, Born Christoph, Schaub Gabriele, Walden Jörg
Department of Psychiatry at the University of Munich, Germany.
J Clin Psychiatry. 2003 Jul;64(7):781-4. doi: 10.4088/jcp.v64n0707.
Levetiracetam is a novel antiepileptic drug with a broad spectrum of efficacy in epilepsy. We have tested the antimanic properties of the drug as an add-on to haloperidol in an open trial.
After giving informed written consent, 10 bipolar I acutely manic (DSM-IV) inpatients were investigated in an on-off-on study design. All patients were treated with 5 to 10 mg/day of haloperidol, depending on tolerability, throughout the investigation. Levetiracetam (up to 4000 mg/day) was added until day 14, then discontinued and reintroduced at day 21. The psychopathologic changes were assessed with the Young Mania Rating Scale (YMRS).
After a mean decrease of the YMRS scores from 29.6 to 17.2 during the first "on" phase, manic symptoms worsened during the "off" period (YMRS score 20.9) and ameliorated again during the second "on" phase, with a decrease of the mean YMRS score to 14.7 at the end of the study. The mean dose of levetiracetam was 3125 mg/day. At day 14, only 2 (20%) of 10 patients were responders (defined as a decrease in YMRS scores of 50%) compared with 7 (70%) of 10 responders at the end of the study at day 28.
The results from this open on-off-on add-on study suggest that levetiracetam exhibited additional antimanic effects. Controlled studies are clearly required.
左乙拉西坦是一种新型抗癫痫药物，对癫痫具有广泛的疗效。我们在一项开放性试验中测试了该药物作为氟哌啶醇附加用药的抗躁狂特性。
在获得书面知情同意后，对10名双相I型急性躁狂（DSM-IV）住院患者采用“开-关-开”研究设计进行调查。在整个研究过程中，所有患者根据耐受性接受5至10毫克/天的氟哌啶醇治疗。添加左乙拉西坦（最高4000毫克/天）直至第14天，然后停药，并在第21天重新用药。使用杨氏躁狂量表（YMRS）评估精神病理变化。
在第一个“开”阶段，YMRS评分平均从29.6降至17.2，在“关”期躁狂症状恶化（YMRS评分为20.9），在第二个“开”阶段再次改善，研究结束时YMRS评分平均降至14.7。左乙拉西坦的平均剂量为3125毫克/天。在第14天，10名患者中只有2名（20%）有反应（定义为YMRS评分降低50%），而在第28天研究结束时，10名有反应者中有7名（70%）。
这项开放性“开-关-开”附加研究的结果表明，左乙拉西坦具有额外的抗躁狂作用。显然需要进行对照研究。
