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J Clin Psychiatry. 2014 Aug;75(8):837-44. doi: 10.4088/JCP.13m08845.
To determine whether a single treatment of botulinum toxin A in the forehead (glabellar) region can improve symptoms of depression in patients with major depressive disorder (MDD), as defined by DSM-IV criteria.
Thirty participants were randomly assigned to receive either placebo or botulinum toxin A (BTA; onabotulinumtoxinA) injections in the forehead. Female participants received 29 units; male participants received 39 units. At week 12, the groups were crossed over. Participants were evaluated at weeks 0, 3, 6, 12, 15, 18, and 24 for improvement in MDD symptoms using the Patient Health Care Questionnaire-9, Beck Depression Inventory (BDI), and 21-Item Hamilton Depression Rating Scale (HDRS-21) objective measurement scales. The primary outcome was the rate of HDRS-21 response, defined as ≥ 50% score reduction from baseline. The study occurred from July 2011 to November 2012.
Patients who received BTA at week 0 (BTA-first group) and at week 12 (BTA-second group) had a statistically significant reduction in MDD symptoms as compared to placebo. Improvement in MDD continued over 24 weeks in the group that received BTA first even though the cosmetic effects of BTA wore off at 12 to 16 weeks. HDRS-21 response rates were 55% (6/11) in the BTA-first group, 24% (4/17) in the BTA-second group, and 0% (0/19) in the placebo group (P < .0001). HDRS-21 remission rates (score ≤ 7) were 18% (2/11), 18% (3/17), and 0% (0/19), respectively (P = .057). HDRS-21 scores dropped -46% and -35% in the BTA-first and -second groups versus -2% in the placebo group (P < .0001). The BDI response rate (≥ 50% reduction from baseline) was 45% (5/11) in the BTA-first group, 33% (6/18) in the BTA-second group, and 5% (1/19) in the placebo group (P = .0067). BDI remission rates (score ≤ 9) were 27% (3/11), 33% (6/18), and 5% (1/19), respectively (P = .09). BDI scores dropped -42% and -35% in the BTA-first and -second groups versus -15% in the placebo group (P < .0001).
Botulinum toxin A injection in the glabellar region was associated with significant improvement in depressive symptoms and may be a safe and sustainable intervention in the treatment of MDD.
ClinicalTrials.gov identifier: NCT01392963.
确定肉毒毒素 A 在额部（眉间）区域的单次治疗是否可以改善符合 DSM-IV 标准的重度抑郁症（MDD）患者的抑郁症状。
30 名参与者被随机分配接受安慰剂或肉毒毒素 A（BTA；onabotulinumtoxinA）注射。女性参与者接受 29 单位；男性参与者接受 39 单位。在第 12 周，两组交叉。在第 0、3、6、12、15、18 和 24 周，使用患者健康调查问卷-9、贝克抑郁量表（BDI）和 21 项汉密尔顿抑郁量表（HDRS-21）客观测量量表评估 MDD 症状的改善情况。主要结局是 HDRS-21 反应率，定义为基线评分降低≥50%。研究于 2011 年 7 月至 2012 年 11 月进行。
与安慰剂相比，在第 0 周（BTA 第一组）和第 12 周（BTA 第二组）接受 BTA 的患者 MDD 症状有统计学显著改善。尽管 BTA 的美容效果在 12 至 16 周时消失，但在接受 BTA 第一组的患者中，MDD 的改善持续了 24 周。BTA 第一组的 HDRS-21 反应率为 55%（6/11），BTA 第二组为 24%（4/17），安慰剂组为 0%（0/19）（P<0.0001）。HDRS-21 缓解率（评分≤7）分别为 18%（2/11）、18%（3/17）和 0%（0/19）（P=0.057）。BTA 第一组和第二组的 HDRS-21 评分分别下降了-46%和-35%，而安慰剂组下降了-2%（P<0.0001）。BDI 反应率（基线评分降低≥50%）在 BTA 第一组为 45%（5/11），在 BTA 第二组为 33%（6/18），在安慰剂组为 5%（1/19）（P=0.0067）。BDI 缓解率（评分≤9）分别为 27%（3/11）、33%（6/18）和 5%（1/19）（P=0.09）。BTA 第一组和第二组的 BDI 评分分别下降了-42%和-35%，而安慰剂组下降了-15%（P<0.0001）。
肉毒毒素 A 在眉间区域的注射与抑郁症状的显著改善相关，可能是 MDD 治疗的一种安全且可持续的干预措施。
ClinicalTrials.gov 标识符：NCT01392963。
