双盲研究：右旋苯丙胺与咖啡因增效治疗耐药性强迫症。

Double-blind study of dextroamphetamine versus caffeine augmentation for treatment-resistant obsessive-compulsive disorder.

机构信息

OCD Clinic, Stanford, CA 94305, USA.

出版信息

J Clin Psychiatry. 2009 Nov;70(11):1530-5. doi: 10.4088/JCP.08m04605. Epub 2009 Jun 30.

DOI:10.4088/JCP.08m04605

PMID:19573497

Abstract

INTRODUCTION

Two small, double-blind, placebo-controlled, single-dose, crossover studies found dextroamphetamine (d-amphetamine) 30 mg clearly superior to placebo in relieving symptoms of obsessive-compulsive disorder (OCD). We conducted a 5-week, double-blind, caffeine-controlled study to test the hypothesis that d-amphetamine, added after an adequate selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) trial, would be more effective than caffeine in reducing residual OCD symptoms of moderate or greater severity.

METHOD

Between August 2006 and February 2008, we enrolled adults with DSM-IV OCD and a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of >or= 20 after >or= 12 weeks of adequate treatment with an SSRI or SNRI. Subjects were randomly assigned to double-blind d-amphetamine 30 mg/d or caffeine 300 mg/d added to their SSRI/SNRI and other medications. Responders (first week mean Y-BOCS score decrease of >or= 20%) entered the study's 4-week double-blind extension phase.

RESULTS

We enrolled 24 subjects, 11 women and 13 men, with a mean (SD) age of 40 (13.2) years and mean baseline Y-BOCS scores of 26.5 (4.1) for the d-amphetamine group (n = 12) and 29.1 (4.0) for the caffeine group (n = 12). At the end of week 1, 6 of 12 d-amphetamine subjects (50%) and 7 of 12 caffeine subjects (58%) were responders. At week 5, the responders' mean Y-BOCS score decreases were, for the d-amphetamine group (last observation carried forward), 48% (range, 20%-80%); and, for the caffeine group, 55% (range, 27%-89%). Obsessive-compulsive disorder and depression improvement were independent. The double-blind remained intact. No subject discontinued the study due to side effects.

CONCLUSIONS

Larger, double-blind, placebo-controlled trials of both d-amphetamine and caffeine augmentation are needed in OCD subjects inadequately responsive to adequate doses of an SSRI or SNRI.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00363298.

摘要

介绍

两项小型、双盲、安慰剂对照、单次剂量、交叉研究发现，右旋苯丙胺（d-苯丙胺）30 毫克在缓解强迫症（OCD）症状方面明显优于安慰剂。我们进行了一项为期 5 周的、双盲、咖啡因对照研究，以检验以下假设：在充分的选择性 5-羟色胺再摄取抑制剂（SSRI）或 5-羟色胺-去甲肾上腺素再摄取抑制剂（SNRI）试验后，添加右旋苯丙胺，将比咖啡因更有效地减少中重度 OCD 症状的残留。

方法

在 2006 年 8 月至 2008 年 2 月期间，我们招募了符合 DSM-IV OCD 标准且耶鲁-布朗强迫量表（Y-BOCS）评分大于等于 20 的成年人，他们在充分接受 SSRI 或 SNRI 治疗后，时间超过 12 周。受试者被随机分配接受双盲右旋苯丙胺 30mg/d 或咖啡因 300mg/d 治疗，同时加用 SSRI/SNRI 和其他药物。应答者（第 1 周平均 Y-BOCS 评分下降大于等于 20%）进入研究的 4 周双盲扩展阶段。

结果

我们共招募了 24 名受试者，其中 11 名女性和 13 名男性，平均（SD）年龄为 40（13.2）岁，平均基线 Y-BOCS 评分分别为：d-苯丙胺组（n=12）26.5（4.1），咖啡因组（n=12）29.1（4.0）。在第 1 周结束时，d-苯丙胺组 12 名受试者中有 6 名（50%）和咖啡因组 12 名受试者中有 7 名（58%）为应答者。在第 5 周，d-苯丙胺组应答者的 Y-BOCS 评分平均下降 48%（范围：20%-80%），咖啡因组为 55%（范围：27%-89%）。强迫症和抑郁的改善是独立的。双盲状态仍然完整。没有受试者因副作用而退出研究。