Agomelatine in the treatment of seasonal affective disorder

RATIONALE: The novel antidepressant agomelatine acts as a melatonergic (MT(1) and MT(2)) receptor agonist and as a serotonin-2C receptor antagonist. Previous studies showed that agomelatine is able to restore disrupted circadian rhythms, which were implicated in the pathophysiology of seasonal affective disorder (SAD). OBJECTIVES: The aim of this study was to investigate the efficacy and tolerability of agomelatine in the treatment of SAD. MATERIALS AND METHODS: Thirty-seven acutely depressed SAD patients were included in an open study with agomelatine (25 mg/day in the evening) over 14 weeks. Efficacy assessments included the Structured Interview Guide for the Hamilton Depression Rating Scale (SAD version; SIGH-SAD), the Clinical Global Impression of Severity (CGI-S) and Improvement (CGI-I), the Circscreen, a self-rating scale for the assessment of sleep and circadian rhythm disorders, and the Hypomania Scale. RESULTS: Agomelatine led to a progressive and statistically significant decrease of SIGH-SAD, CGI-S, and CGI-I scores from week 2 onward (p < 0.001). Furthermore, scores on the Circscreen improved significantly during the study (p < 0.001). Treatment with agomelatine over 14 weeks yielded a response rate of 75.7% (SIGH-SAD <50% of baseline value) and a remission rate (SIGH-SAD <8) of 70.3% in the intention to treat sample. Scores on the Hypomania Scale were consistently low during the study. Agomelatine showed good overall tolerability: throughout the study only one adverse event (mild fatigue) was related to the study drug. CONCLUSIONS: The results of this study suggest that seasonal depression may be effectively and safely treated with agomelatine.     

舍曲林与氯米帕明治疗难治性强迫症对照研究

目的探讨舍曲林与氯米帕明治疗难治性强迫症的疗效和不良反应。方法对难治性强迫症60例,随机分为两组,分别用舍曲林与氯米帕明治疗8周。采用强迫症量表（Y-BOCS）和副反应量表（TESS）评价疗效及不良反应。结果两药的总体疗效相仿。舍曲林不良反应小,尤其是心血管系统及抗胆碱能不良反应少。结论舍曲林尤适用于难治性强迫症。     

舍曲林与多塞平治疗门诊抑郁症的对照研究

目的比较舍曲林治疗抑郁症的临床疗效和安全性。方法将46例抑郁症患者随机分为舍曲林组和多塞平(多虑平)组,分别给予舍曲林和多塞平治疗6周进行对照研究,用汉密尔顿抑郁量表(HAMD)及不良反应量表(TESS)评定其疗效和不良反应。结果舍曲林和多塞平对治疗抑郁症疗效相近,但舍曲林起效较快。TESS评定舍曲林组不良反应少于多塞平组。结论舍曲林治疗抑郁症效果肯定,不良反应轻且少。     

1,25 (OH)2 vitamin D3 levels in seasonal affective disorder: Effects of light

1,25 (OH)₂ vitamin D₃ levels were assessed in nine females and six males with winter seasonal affective disorder and in 15 age- and gender-matched controls in winter during periods with and without treatment with light therapy. No difference was found between groups or across conditions, though wide variations within each group make the presence of a type II error possible.     

舍曲林和氯丙咪嗪治疗68例惊恐障碍的疗效比较

目的评价舍曲林治疗惊恐障碍的疗效和安全性。方法采用随机单盲病例对照研究,为期24周．以临床判断和PASS、HAMD、HAMA量表来评定临床效果,以TESS来评定药物不良反应。结果入组68例舍曲林组36例,氧丙味嗪组32例）．舍曲林组最高剂量平均132．5±25．25mg·d^-1。氯丙咪嗪组为153．62mg·d^-1．临床疗效。第四周末舍曲林有效率为77．7％,氯丙咪嗪组为65．6％．两组有统计学盖异（P〈0．05）,而二十四周末两组的有效率分别为100％和96．9％,两组无明显差异。从PASS、HAMD、HAMA量表来看舍曲林组从第二周末开培有明显下降,而氯丙咪嗪组则在第三或第四周以后才开始明显改变。从副反应来看舍曲林组总的发生率13．61%。明显低于氛丙味嗪组的24．68％。结论舍曲林治疗惊恐障碍和氯丙咪嗪比较具有起效快,疗效好。副作用小等特点。是一种安全有效的治疗惊恐障碍药物。     

舍曲林联合行为疗法治疗强迫症的随机对照研究

目的研究舍曲林联合行为疗法治疗强迫症的临床疗效。方法将门诊与住院的强迫症患者37例随机分为舍曲林单一药物治疗组与舍曲林合并行为治疗的综合治疗组。全部患者在人组时和治疗12周时用耶鲁一布朗量表进行强迫症状严重程度评定。结果综合治疗组在12周时耶鲁一布朗量表评分显著低于单一舍曲林用药组,舍曲林联合行为疗法治疗强迫症有效,且临床疗效显著优于单一舍曲林用药。结论与舍曲林单一用药治疗相比．舍曲林联合行为疗法治疗强迫症的疗效更明显。     

A comparative,randomized, double-blind study of trazodone prolonged-release and sertraline in the treatment of major depressive disorder

ABSTRACT

Objectives: To evaluate the efficacy and safety of trazodone prolonged-release compared with sertraline in the treatment of patients with major depression.

Research design and methods: A total of 122 patients aged 19–64 years were enrolled in this multicenter, double-blind, double-dummy, randomized, comparator-controlled study. Patients received 7 days of single-blind placebo treatment followed by 6 weeks of double-blind treatment with trazodone prolonged-release 150–450?mg/day (n = 62) or sertraline 50–100?mg/day (n = 60).

Outcome measures: Efficacy was evaluated by mean changes from baseline in the Hamilton Depression Rating scale (HAM‐D), Montgomery Asberg Depression Rating Scale, Hamilton Anxiety Rating scale, and the Clinical Global Impression-Global Improvement/Severity scores; and by the rates of patients responding to treatment and considered to be in remission. Time to onset of efficacy and safety were assessed.

Results: Trazodone and sertraline were equally effective in reducing depressive symptoms and promoting remission, and had similar onset times. In the Intent-to-Treat population, there were no significant differences in favor of trazodone at study endpoint in all efficacy measures, while a statistically significant difference was detected in the Per-Protocol population on HAM‐D and in the percentage of responders. Analysis of HAM‐D factors (anxiety/somatization, cognitive disturbance, retardation, and sleep disturbance) indicated that sleep disturbances were significantly less evident for patients taking trazodone at study endpoint. Adverse drug reactions, mostly of mild intensity, were reported in 42% of trazodone-treated patients (mainly of the nervous system) and 43% of sertraline-treated patients (mainly gastrointestinal). One event was considered to be serious: a patient treated with trazodone 450?mg/day showed moderate anxiety/tremor/insomnia and was hospitalized. Treatment was discontinued; the patient made a full recovery.

Conclusions: This study showed that after 6 weeks, trazodone and sertraline were not different in reducing symptoms of depression and in producing disease remission. Tolerability profiles reflected the differing pharmacological properties of these antidepressants. Trazodone may be a therapeutic option in the treatment of patients with major depression showing prevalent sleep disturbances.     

Mirtazapine in seasonal affective disorder (SAD): a preliminary report

Beside light therapy, selective serotonin reuptake inhibitors (SSRI) are the recommended treatment for patients suffering from Seasonal Affective Disorder (SAD). They seem to particularly resolve the atypical symptoms of SAD, while tricyclic antidepressants tend to worsen them. The latter has been linked to the broader spectrum of neurotransmitter modulation tricyclics enfold. Mirtazapine is a novel antidepressant providing a broad spectrum of neurotransmitter modulation on a basis of high selectivity. In order to evaluate the antidepressant efficacy of mirtazapine in the treatment of SAD, eight depressed and drug‐naive SAD patients entered a 4 week drug surveillance and received 30 mg of mirtazapine per day. Clinical response was assessed using the Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder Version (SIGH‐SAD). Our preliminary results show that mirtazapine was not only well tolerated by the patients but also efficacious in the treatment of SAD. Copyright © 1999 John Wiley & Sons, Ltd.     

研究舍曲林与喹硫平治疗强迫症患者的临床效果

目的 分析舍曲林与喹硫平治疗强迫症患者的临床效果.方法 100例强迫症患者,根据随机数字表法分为对照组与研究组,各50例.对照组采用舍曲林治疗,研究组采用舍曲林+喹硫平治疗.对比两组治疗前后耶鲁-布朗强迫症状量表(Y-BOCS)评分、汉密尔顿焦虑量表(HAMA)评分及疗效.结果 治疗后,研究组的Y-BOCS评分(7.0...     

短程三氟噻吨/四甲蒽丙胺联合舍曲林治疗抑郁障碍

目的 研究短程三氟噻吨／四甲蒽丙胺联合舍曲林治疗躯体疾病伴发抑郁障碍的临床疗效。方法 68例躯体疾病伴发抑郁障碍患者随机分为两组（治疗组36例，对照组32例），均给予舍曲林75mg／d，连用4周，其中治疗组早期合用三氟噻吨／四甲蒽丙胺，每早1片，连用2周。采用汉密顿抑郁量表（HAMD）24项和汉密顿焦虑量表（HAMA）14项评定临床疗效。结果 在治疗后3d、1周及2周治疗组HAMD评分改善的有效率分别为47．2％、69．4％、80．6％，均高于相应对照组15．6％、28．1％、46．9％，差异有统计学意义（P〈0．01）；HAMA评分改善的有效率也明显高于相应对照组。在治疗4周后治疗组两种评分改善的有效率也均高于对照组，但差异无统计学意义（P〉0．01）。结论 三氟噻吨／四甲蒽丙胺可作为舍曲林的增效剂以缩短其起效时间且提高其疗效，两药合用可作为治疗躯体疾病伴发抑郁障碍的一种新策略。     

抗抑郁药物在双相情感障碍治疗中的应用

抗抑郁药物在双相情感障碍中的应用备受关注。抗抑郁药物治疗双相抑郁急性期疗效较为肯定,但有转躁等问题;长期治疗的预防效果尚有待进一步研究。本文从循证医学角度,综述抗抑郁药物在双相情感障碍(主要是双相抑郁)急性期和维持期治疗中的疗效以及转躁情况,阐述双相情感障碍治疗中抗抑郁药物合理使用的重要性和必要性。     

Escitalopram versus sertraline in the treatment of major depressive disorder: a randomized clinical trial*

ABSTRACT

Objective: This trial was conducted to compare the efficacy and tolerability of a fixed dose of escitalopram 10?mg/day with sertraline optimally dosed within its recommended dose range (50–200?mg/day) for the treatment of major depressive disorder.

Methods: In this multicenter trial, depressed patients (DSM?IV defined; baseline Montgomery–Asberg Depression Rating Scale [MADRS] ≥ 22) aged 18–80 years were randomly assigned to 8 weeks of double-blind treatment with escitalopram (10?mg/day) or sertraline (50–200?mg/day) following a 1?week single-blind placebo lead-in period. There was no placebo comparison arm. Sertraline was initiated at 50?mg/day, and could be increased by 50?mg/day at weekly intervals based on clinical need and tolerability at the lower dose level. The blind was maintained with matching double-blind placebo capsules for the escitalopram group. Change from baseline to endpoint in MADRS total score (last observation carried forward) was the primary efficacy measure.

Results: A total of 212 patients received double-blind medication. At week 8, the mean sertraline dosage was 144?mg/day (median = 150?mg/day). Mean changes from baseline to endpoint in MADRS scores were –19.1 and –18.4 for the escitalopram and sertraline groups, respectively. At endpoint, 75% and 70% of escitalopram- and sertraline-treated patients, respectively, were responders (≥ 50% improvement from baseline in mean MADRS scores). Both treatments were generally well tolerated; only 2% and 4% of patients prematurely discontinued escitalopram and sertraline treatment, respectively, due to adverse events.

Conclusion: No differences in efficacy were observed for fixed-dose escitalopram 10?mg/day and sertraline flexibly dosed from 50–200?mg/day. At these doses, both escitalopram and sertraline were generally well tolerated.     

安神补脑液联合舍曲林治疗脑梗死后睡眠障碍的疗效观察

目的观察安神补脑液联合舍曲林治疗脑梗死后睡眠障碍的临床疗效。方法选取2015年7月—2016年6月重庆市开州区人民医院收治的112例脑梗死后睡眠障碍患者随机分为对照组和治疗组,每组各56例。对照组患者口服盐酸舍曲林片,1片/次;治疗组在对照组治疗基础上口服安神补脑液,10 m L/次,2次/d。两组疗程均为4周。观察两组的临床疗效,比较两组治疗前后匹兹堡睡眠质量指数(PSQI)、阿森斯失眠量表(AIS)评分、美国国立卫生研究院卒中量表(NIHSS)评分、汉密尔顿抑郁量表(HAMD)评分,睡眠状况相关指标。结果治疗后,对照组和治疗组的总有效率分别为71.43%、91.07%,两组比较差异有统计学意义(P0.05)。治疗后,两组PSQI评分、AIS评分、NIHSS评分、HAMD评分均显著降低,同组治疗前后差异有统计学意义(P0.05);治疗后,治疗组PSQI评分、AIS评分、NIHSS评分、HAMD评分低于对照组,两组比较差异有统计学意义(P0.05)。治疗后,两组睡眠总时间、睡眠效率均较治疗前显著提高,夜间觉醒次数减少,同组治疗前后差异有统计学意义(P0.05);治疗后,治疗组睡眠总时间、睡眠效率高于对照组,夜间觉醒次数少于对照组,两组比较差异有统计学意义(P0.05)。结论安神补脑液联合舍曲林治疗脑梗死后睡眠障碍,临床疗效确切,患者睡眠质量改善明显,具有一定的临床推广应用价值。     

Double-blind, placebo-controlled study of single-dose metergoline in depressed patients with seasonal affective disorder

A role for serotonin in season affective disorder (SAD) has been explored with a variety of serotonergic pharmacologic agents. The authors initially hypothesized that metergoline, a nonspecific serotonin antagonist, would exacerbate depressive symptoms. In a small, open-label pilot study, the authors observed the opposite effect. They decided to follow up on this finding with this formal study. The study followed a double-blind, randomized cross-over design. Sixteen untreated, depressed patients with SAD received single oral doses of metergoline 8 mg and of placebo, spaced 1 week apart. Fourteen patients were restudied after 2 weeks of light treatment. Depression ratings using the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version were performed at baseline and at 3 and 6 days after each intervention. These data were analyzed by baseline-corrected repeated measures with analysis of variance. In the off-lights condition, severity of depression was diminished after metergoline compared with placebo administration (p = 0.001). Patient daily self-ratings suggested that the peak effect occurred 2 to 4 days after study drug administration. In contrast, after 2 weeks of treatment with bright artificial light, metergoline did not demonstrate a significant effect on mood. These data suggest that single doses of metergoline may have antidepressant effects that last several days. Possible mechanisms include 5-hydroxytryptamine(2) receptor downregulation and dopamine agonism.     

A randomized double-blind placebo-controlled study of tropisetron in the treatment of outpatients with generalized anxiety disorder

The selective 5HT₃ antagonist tropisetron was studied in 91 outpatients meeting DSM-III criteria for Generalized Anxiety Disorder. Following a placebo washout period of up to 1 week, one of three active treatments (tropisetron 0.5 mg, 5 mg, or 25 mg daily) or placebo was given for a further 3 weeks. After 7 days treatment termination rates due to inefficacy showed a statistically significant dose-related therapeutic effect of tropisetron. Similar effects were seen on the Hopkins Symptom Check List total score and the Global Impression Scale. The Hamilton Anxiety Scale showed a similar trend which, however, failed to reach statistical significance. At day 21 tropisetron showed significant dose-dependent effects on all anxiety-related outcome measures. The incidence of adverse events was low and the severity generally mild. Most frequent complaints were headache, nausea, constipation and nervousness. Laboratory tests and physical examination performed at baseline and study end showed no significant treatment effects.(Drs Braconnier, Combes Lepastier, Danic, Deyrieux, Fabiani, Lazartigues, Peyrouzet, Raikovic and Supino-Viterbo)     

Treatment strategies in patients with major depression not responding to first-line sertraline treatment

RATIONALE: A large proportion of patients with major depression do not respond sufficiently to any first-line treatment. OBJECTIVES: The aim of this study was to compare a strategy of sertraline dose increase with a strategy of adding mianserin in patients with major depression insufficiently responding to 6 weeks of open treatment with sertraline, controlling for the effect of an extended duration of treatment. METHODS: One thousand six hundred and twenty-nine patients, 18-65 years of age, with major depression scoring at least 18 on the 17-item Hamilton depression scale (HDS) were treated openly with 50 mg/day sertraline, and patients who after 4 weeks had not responded (achieving at least a 50% reduction in score on the HDS) were treated with 100 mg/day sertraline for an additional 2-week period. The patients who had still not responded were then randomised to double-blind treatment for an additional 5 weeks with either 100 mg/day sertraline plus placebo, 200 mg/day sertraline plus placebo or 100 mg/day sertraline plus 30 mg/day mianserin. RESULTS: After 6 weeks of open treatment, 60% had responded and 22% had dropped out, leaving 295 non-responding patients (18%) for randomisation. In the intention-to-treat-analysis, continuing the treatment with 100 mg/day sertraline resulted in response in 70% of the non-responders, similar to the response rate (67%) obtained in the patients who had mianserin added. However, increasing the sertraline dose to 200 mg/day resulted in a lower response rate at 56% ( P<0.05). Similar results were seen in the completers. A substantial increase in the accumulated response rate from week 6 to week 8 was seen. There was no influence of baseline variables, including the presence of melancholic features on the overall post-randomisation response rate. CONCLUSION: After 6 weeks of insufficient antidepressant treatment with 50-100 mg/day sertraline, a continued treatment with 100 mg/day sertraline can be considered until at least week 8 before considering changing strategy, unless the condition deteriorates.     

舍曲林联合齐拉西酮治疗强迫症的临床效果

目的探讨舍曲林联合齐拉西酮治疗强迫症的临床效果和安全性。方法将60例强迫症患者随机分为两组,各30例,观察组采用舍曲林联合齐拉西酮治疗,对照组采用舍曲林治疗,疗程8周。比较两组的疗效、Y-BOCS评分、TESS评分和不良反应发生率。结果观察组的总有效率为83.3%,显著高于对照组的60.0%,差异有统计学意义（P〈0.05）。两组治疗后Y-BOCS评分低于治疗前,观察组治疗4、6、8周Y-BOCS评分低于对照组,差异有统计学意义（P〈0.05）。两组的TESS评分和不良反应发生率比较差异无统计学意义（P〉0.05）。结论舍曲林联合齐拉西酮治疗强迫症的疗效显著,起效快,安全性较好。     

舍曲林与帕罗西汀治疗首发抑郁症的24周对照研究

目的：比较舍曲林与帕罗西汀治疗首发抑郁症的疗效和安全性。方法：将104例首发抑郁症患者随机分为舍曲林组61例,帕罗西汀组43例,共治疗24周,采用汉密尔顿抑郁量表（HAMD）评定临床疗效,不良反应量表（TESS）评定不良反应。结果：舍曲林组显效率为77%,帕罗西汀组显效率为73%,两组间比较无显著性差异。治疗前后HAMD评分比较两组均有显著性差异,两组间则无显著性差异。两组不良反应TESS评分比较在个别项目上有显著性差异。结论：舍曲林与帕罗西汀治疗首发抑郁症均有良好的疗效,但从不良反应的角度舍曲林可能更适合抑郁症的长期治疗。     

文献计量学分析我国双相情感障碍的发展趋势

目的通过分析我国双相情感障碍的文献分布,探讨我国双相情感障碍的发展趋势。方法采用文献计量学方法和MicrosoftExcel技术,通过利用中国生物医学文献数据库中收录的有关以双相情感障碍为主题的文献,从时间分布、单位分布、地域分布、期刊分布、第一作者分布和主要内容等方面,进行多角度文献分析。结果双相情感障碍文献的时间分布、单位分布、地域分布与地区经济发展密切相关;浙江常州全军精神卫生中心解放军第102医院、深圳市精神卫生研究所（深圳市精神卫生中心）、南京医科大学附属脑科医院及在以上单位工作的作者可视为该病的核心研究机构和研究者;《临床精神医学杂志》（6．67％）、《四川精神卫生》（5．14％）、《上海精神医学》（4．72％）、《中国神经精神疾病杂志》（4．16％）可视为该病研究的核心期刊;国内学者对该病的研究主要集中于临床药物治疗、临床诊断、临床病例报告（约占临床研究的61．98％）、流行病学调查（约占预防医学研究的63％）等方面,对于双相情感障碍预防方面（约占论文总数的28．97％）及合并外科疾病围手术期（约占临床研究的4．04％）的专题研究报道较少。结论双相情感障碍研究在国内尚处于初步研究阶段,各地区发展不平衡,对该病的预防和治疗认识不足。各地区应重视该病的防治工作,建立预警机制,制定相应防治措施,防止该病的流行和突发事件的发牛。     

Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study

ObjectiveThe primary aim of this study was to assess the efficacy of atomoxetine in improving ADHD and ODD symptoms in paediatric patients with ADHD and comorbid oppositional defiant disorder (ODD), non-responders to previous psychological intervention with parent support.MethodsThis was a multicentre, randomised, placebo-controlled trial conducted in patients aged 6–15 years, with ADHD and ODD diagnosed according to the DSM-IV criteria by a structured clinical interview (K-SADS-PL). Only subjects who are non-responders to a 6-week standardized parent training were randomised to atomoxetine (up to 1.2 mg/kg/day) or placebo (in a 3:1 ratio) for the following 8-week double blind phase.ResultsOnly 2 of the 156 patients enrolled for the parent support phase (92.9% of males; mean age: 9.9 years), improved after the parent training program; 139 patients were randomised for entering in the study and 137 were eligible for efficacy analysis. At the end of the randomised double blind phase, the mean changes in the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV) ADHD subscale were − 8.1 ± 9.2 and − 2.0 ± 4.7, respectively in the atomoxetine and in the placebo group (p < 0.001 between groups); changes in the ODD subscale were − 2.7 ± 4.1 and − 0.3 ± 2.6, respectively in the two groups (p = 0.001 between groups). The CGI-ADHD-S score decreased in the atomoxetine group (median change at endpoint: − 1.0) compared to no changes in the placebo group (p < 0.001 between groups). Statistically significant differences between groups, in favour of atomoxetine, were found in the CHIP-CE scores for risk avoidance domain, emotional comfort and individual risk avoidance subdomains. An improvement in all the subscales of Conners Parents (CPRS-R:S) and Teacher (CTRS-R:S) subscales was observed with atomoxetine, except in the cognitive problems subscale in the CTRS-R:S. Only 3 patients treated with atomoxetine discontinued the study due to adverse events. No clinically significant changes of body weight, height and vital signs were observed in both groups.ConclusionsTreatment with atomoxetine of children and adolescents with ADHD and ODD, who did not initially respond to parental support, was associated with improvements in symptoms of ADHD and ODD, and general health status. Atomoxetine was well tolerated.