米氮平与氟西汀治疗抑郁症的多中心对照研究

目的 :评价米氮平与氟西汀治疗抑郁症的有效性和安全性。方法 :采用DSM Ⅳ抑郁症的诊断标准 ,为期 6wk的观察。结果 :经 6wk治疗 ,米氮平组有效率和治愈率分别为 78%和 64% ,氟西汀组为 90 %和 55% (P >0 .0 5)。治疗 1wk后 ,米氮平组的有效率高于氟西汀组。 2组HAMD和MADRS总分治疗前后比较差异有显著意义 ,2组间差异无显著意义。治疗 1wk后 ,米氮平组HAMD总分和睡眠紊乱因子分的减分较氟西汀组明显。米氮平组主要不良反应是眩晕或 (和 )头昏等 ,与氟西汀组相比 ,米氮平组嗜睡发生率高 (P <0 .0 5)。结论 :米氮平是一种安全、有效的新型抗抑郁药物。起效较快 ,且有改善焦虑及睡眠作用     

Mirtazapine versus venlafaxine in hospitalized severely depressed patients with melancholic features

The aim of this multicenter, randomized, double-blind, 8-week study was to compare the antidepressant efficacy and tolerability of mirtazapine and venlafaxine in the treatment of hospitalized patients with DSM-IV diagnosis of severe depressive episode with melancholic features. Patients with a baseline score of > or = 25 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17) were randomly assigned to receive treatment with either mirtazapine (N = 78, 15-60 mg/day) or venlafaxine (N = 79, 75-375 mg/day, twice a day) in a rapid up-titration schedule. Efficacy was assessed with the Montgomery-Asberg Depression Rating Scale (MADRS), HAM-D-17, and Clinical Global Impression scale, and quality of life was assessed with the Quality of Life, Enjoyment, and Satisfaction Questionnaire and Quality of Life in Depression Scale. Tolerability was assessed with the Utvalg for Kliniske Undersogelser (UKU) side effect scale and by reporting adverse events. Both drugs were effective in reducing overall symptoms of depression, showing substantial reductions in group mean MADRS scores (-20.1 for mirtazapine and -17.5 for venlafaxine) and HAM-D-17 scores (-17.1 for mirtazapine and -14.6 for venlafaxine) at the end of the treatment. Although not statistically significant, at all assessment times higher percentages of patients treated with mirtazapine were classified as responders (> or =50% reduction) on the HAM-D (at endpoint, 62% vs. 52%) and MADRS (at endpoint: 64% vs. 58%). Likewise were the percentages of remitters (HAM-D score < or =7; MADRS score < or =12) also higher in the mirtazapine group. A statistically significant difference favoring mirtazapine was found on the HAM-D Sleep Disturbance factor at all assessment points (p < or = 0.03). Both treatments were well tolerated. Although slightly more subjects treated with mirtazapine reported at least one adverse event, a statistically significantly higher percentage of patients treated with venlafaxine (15.3%) than mirtazapine (5.1%) dropped out because of adverse events (p = 0.037). Quality of life improved in both treatment groups. In this study, treatment with mirtazapine resulted in a trend toward more responders and remitters than treatment with venlafaxine and in significantly fewer dropouts as a result of adverse events.     

西酞普兰联合米氮平治疗抑郁症伴睡眠障碍的临床疗效观察

目的观察西酞普兰联合米氮平治疗抑郁症伴睡眠障碍的临床疗效。方法104例抑郁症伴睡眠障碍患者,应用随机数字表法分为对照组及观察组,各52例。对照组应用西酞普兰治疗,观察组在对照组的基础上应用米氮平治疗。对比两组的临床疗效、匹兹堡睡眠质量指数量表(PSQI)评分及不良反应发生情况。结果观察组患者治疗总有效率98.08%高于对照组的80.77%,差异有统计学意义(P<0.05)。治疗后,两组患者PSQI评分均低于治疗前,且观察组PSQI评分(8.5±1.1)分低于对照组的(12.2±1.4)分,差异有统计学意义(P<0.05)。观察组不良反应发生率为21.15%,高于对照组的17.31%,但差异无统计学意义(P>0.05)。结论西酞普兰联合米氮平治疗抑郁症伴睡眠障碍的临床疗效显著,是一种优秀的治疗方法。     

The effect of escitalopram on sleep problems in depressed patients

The results from three 8-week escitalopram studies in major depressive disorder are presented with respect to efficacy and the effect on sleep quality, both in the full population and the subpopulation of patients with sleep problems at baseline.Analysis of pooled data from these randomized, double-blind, placebo-controlled, studies in which citalopram was the active reference, showed a significant improvement for escitalopram-treated patients (n = 52.0) in the Montgomery-Asberg depression rating scale (MADRS) item 4 ('reduced sleep') scores at weeks 6 and 8 compared with placebo (n=398; p < 0.01) and at weeks 4, 6 and 8 (n = 403; p < 0.05) compared with citalopram.Escitalopram-treated patients with sleep problems (MADRS item 4 score > or = 4; n = 254) at baseline showed a statistically significant improvement in mean MADRS item 4 scores at weeks 4, 6 and 8 compared with patients treated with placebo (n = 191; p < 0.05) or citalopram (n = 193; p < 0.01). These patients also showed a statistically significant (p < 0.05) and clinically relevant improvement in MADRS total score after escitalopram treatment compared with citalopram at weeks 1, 4, 6 and 8 (observed cases) and endpoint (-2.45; last observation carried forward [LOCF]). Statistical significance in favour of escitalopram versus placebo treatment was found at all visits, including endpoint (-4.2; LOCF).Thus, these post-hoc analyses suggest that escitalopram has a significant beneficial effect compared with placebo or citalopram in reducing sleep disturbance in patients suffering from major depressive disorder. The effect of escitalopram in improving 'reduced sleep' scores was clearly seen in patients with more severe sleep disturbance at baseline. A further prospective study is needed to establish this useful clinical effect in insomniac depressives.     

Mirtazapine naturalistic depression study (in Sweden)--MINDS(S): clinical efficacy and safety

OBJECTIVE: To study how implementation of a naturalistic trial design for mirtazapine treatment in major depressive disorder for six (up to 12) months could be used and evaluated by means of clinical efficacy and safety. METHOD: An open-labelled, prospective, multicenter, non-comparative trial was conducted during a 2-year period in patients with major depression according to DSM-IV treated in psychiatric departments and primary care in Sweden. Minimal inclusion and exclusion criteria were used in order to diminish the potential patient selection bias. Maximum flexibility of the dosage of mirtazapine was allowed, and clinical assessments included MADRS, CGI, vital signs and spontaneous reporting of adverse events. RESULTS: 192 patients were found eligible and enrolled in the study. A significant improvement in depressive symptoms according to MADRS and CGI was observed including particularly marked sleep improvement early in the treatment. Slight increases in body weight and BMI were observed. The investigational drug was well tolerated overall. CONCLUSION: The clinical efficacy and safety of mirtazapine found in this naturalistic setting is in line with previously reported data on mirtazapine in traditional controlled clinical trials. The results confirm that the naturalistic study design facilitated conduct of the trial. The authors suggest that this type of study design should also be applied to other antidepressant drugs that are frequently prescribed in the general population.     

Comparison of the effects of mirtazapine and fluoxetine in severely depressed patients

INTRODUCTION: Depression is a major global problem associated with large medical, sociological and economic burdens. Mirtazapine (Remeron, Organon NV, The Netherlands) is an antidepressant with a unique mechanism of action that has similar or superior efficacy to TCAs and SSRIs in moderate-to-severe depression. However, this agent has not yet been tested in patients with severe depression alone. OBJECTIVE: To compare the antidepressant efficacy and tolerability of mirtazapine and fluoxetine and their effects on anxiety and quality of life in patients with severe depression (> or = 25 points on the first 17 items of the Hamilton Depression Rating Scale [HDRS-17]). METHODS: In this double-blind study, 297 severely depressed patients were randomised to receive mirtazapine 15-60 mg/day (n = 147) or fluoxetine 20-40 mg/day (n = 152) for 8 weeks. 294 subjects were actually treated and 292 included in the intent-to-treat population. Symptom severity was measured by the HDRS-17, Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression (CGI) rating scale. Quality of life was self-assessed by patients using the Leeds Sleep Evaluation Questionnaire and the Quality of Life, Enjoyment and Satisfaction Questionnaire. Adverse events were recorded throughout the study. RESULTS: No statistically significant differences were noted between the two groups in change from baseline HDRS-17 score at any time point; both treatments were associated with large (approximately 15 points) decreases by study end. However, more mirtazapine-treated patients tended to exhibit a > or = 50% decrease in HDRS score (significant at day 7; 9.0% vs 0.7%, p = 0.002). Significant differences in favour of mirtazapine were also observed at day 14 for changes in MADRS scores (-10.9 vs -8.5, p = 0.006) and the proportion of patients with > or = 50% decrease in MADRS score (21.4% vs 10.9%, p = 0.031). On the CGI, the proportion of 'much/very much improved' patients tended to be greater with mirtazapine (significant at day 7; 9.7% vs 3.4%, p = 0.032). No significant between-group differences were observed for the majority of quality-of-life measures. However, mirtazapine produced significantly better improvements on 'sleeping assessment 1' (14.9 +/- 5.2 vs 13.7 +/- 5.4, p = 0.028) and 'sleeping assessment 2' (p = 0.013) than fluoxetine. Both agents were generally well tolerated but mirtazapine-treated patients experienced a mean weight gain of 0.8 +/- 2.7 kg compared with a mean decrease in weight of 0.4 +/- 2.1 kg for fluoxetine-treated patients (p < 0.001). CONCLUSIONS: Mirtazapine is as effective and well tolerated as fluoxetine in the treatment of patients with severe depression.     

Naltrexone augmentation in OCD: A double-blind placebo-controlled cross-over study

Current treatments for Obsessive Compulsive Disorder (OCD) rely primarily on serotonergic mechanisms. However, approximately 30% of patients do not respond to serotonin reuptake inhibitors and remain chronically ill. Given the behavioral similarities between some of the compulsive behaviors in OCD and addiction, we hypothesized that the opioid antagonist naltrexone might attenuate compulsions in OCD as well. The effect of naltrexone augmentation to SRI was compared to placebo in 10 OCD outpatients who had not responded to an adequate dose of SSRI or clomipramine for at least 2 months. Participants underwent 5 weeks of treatment with naltrexone or placebo (and 1 week of tapering) in a randomized, double-blind, cross-over design. Patients were evaluated weekly using the Y-BOCS, CGI, HAM-A, and MADRS scales. A two-way repeated measures MANOVA revealed no significant effect for Y-BOCS. However, while receiving naltrexone, patients had significantly higher scores on CGI, MADRS and HAM-A as compared to placebo. The lack of significant findings on OC symptoms could be due to either ceiling effect or alternatively, due to a non-specific exacerbation on anxiety and depression but not on OC symptoms.     

Efficacy of prolonged release melatonin in insomnia patients aged 55–80 years: quality of sleep and next-day alertness outcomes

ABSTRACT

Objective: Melatonin, the hormone produced nocturnally by the pineal gland, serves as a circadian time cue and sleep-anticipating signal in humans. With age, melatonin production declines and the prevalence of sleep disorders, particularly insomnia, increases. The efficacy and safety of a prolonged release melatonin formulation (PR-melatonin; Circadin 2?mg) were examined in insomnia patients aged 55 years and older.

Design: Randomised, double blind, placebo-controlled.

Setting: Primary care.

Methodology: From 1248 patients pre-screened and 523 attending visit 1, 354 males and females aged 55–80 years were admitted to the study, 177 to active medication and 177 to placebo. The study was conducted by primary care physicians in the West of Scotland and consisted of a 2‐week, single blind, placebo run-in period followed by a 3‐week double blind treatment period with PR-melatonin or placebo, one tablet per day at 2 hours before bedtime.

Main outcome measures: Responder rate (concomitant improvement in sleep quality and morning alertness on Leeds Sleep Evaluation Questionnaire [LSEQ]), other LSEQ assessments, Pittsburgh Sleep Quality Index (PSQI) global score, other PSQI assessments, Quality of Night and Quality of Day derived from a diary, Clinical Global Improvement scale (CGI) score and quality of life (WHO‐5 well being index).

Results: Of the 354 patients entering the active phase of the study, 20 failed to complete visit 3 (eight PR-melatonin; 12 Placebo). The principal reasons for drop-out were patient decision and lost to follow-up. Significant differences in favour of PR-melatonin vs. placebo treatment were found in concomitant and clinically relevant improvements in quality of sleep and morning alertness, demonstrated by responder analysis (26% vs. 15%; p = 0.014) as well as on each of these parameters separately. A significant and clinically relevant shortening of sleep latency to the same extent as most frequently used sleep medications was also found (–24.3 vs.–12.9 minutes; p = 0.028). Quality of life also improved significantly (?p = 0.034).

Conclusions: PR-melatonin results in significant and clinically meaningful improvements in sleep quality, morning alertness, sleep onset latency and quality of life in primary insomnia patients aged 55 years and over.

Trial registration: The trial was conducted prior to registration being introduced.     

阿戈美拉汀与米氮平治疗抑郁症伴睡眠障碍的效果对比

目的对比阿戈美拉汀与米氮平治疗抑郁症伴睡眠障碍的效果。方法88例抑郁症伴睡眠障碍患者,随机分为对照组及观察组,各44例。对照组使用米氮平治疗,观察组使用阿戈美拉汀治疗。比较两组患者的临床疗效,治疗前后的汉密尔顿抑郁量表(HAMD-17)、蒙哥马利抑郁评定量表(MADRS)、匹兹堡睡眠质量指数量表(PSQI)评分,治疗前后的睡眠结构指标[睡眠潜伏期、睡眠效率、觉醒时间、思睡期(S1)+浅睡期(S2)、中度睡眠期(S3)+深睡期(S4)、快速眼动期(REM)、实际睡眠时间]。结果观察组患者的治疗总有效率为86.36%,明显高于对照组的68.18%,差异具有统计学意义(P<0.05)。治疗后,观察组患者的HAMD-17评分(11.92±2.83)分、MADRS评分(11.53±2.47)分、PSQI评分(5.45±1.03)分均明显低于对照组的(14.37±3.15)、(19.74±3.59)、(8.97±1.34)分,差异均具有统计学意义(P<0.05)。治疗后,观察组患者的睡眠潜伏期、觉醒时间、S1+S2均短于对照组,睡眠效率高于对照组,S3+S4、REM、实际睡眠时间均长于对照组,差异均具有统计学意义(P<0.05)。结论阿戈美拉汀治疗抑郁症伴睡眠障碍的效果更佳,对抑郁症状及睡眠结构均有明显改善效果,有助于调整睡眠周期,提升睡眠质量。     

米氮平与西酞普兰治疗老年抑郁症的对照研究

目的探讨米氮平和西酞普兰对老年抑郁症的疗效和安全性。方法将72例老年抑郁症患者随机分为研究组和对照组,分别给予米氮平和西酞普兰治疗,疗程8周。采用汉密尔顿抑郁量表(HAMD)及副反应量表(TESS)评定疗效和不良反应。结果治疗8周后,研究组和对照组有效率分别为88.89%,86.11%(P>0.05)。两组治疗后HAMD总分、焦虑/躯体化因子分及睡眠障碍因子分均有明显下降(P<0.05或0.01),但研究组下降更迅速、更明显(P<0.05或0.01)。两组不良反应发生率和TESS评分均无明显差异(P>0.05)。结论与西酞普兰相比,米氮平治疗老年性抑郁症同样安全有效,但起效更快,对于改善失眠、焦虑、躯体化症状尤其有优势。     

西酞普兰合并丁螺环酮治疗难治性抑郁症33例

目的观察西酞普兰合并丁螺环酮治疗难治性抑郁症的疗效和安全性。方法将67例患者随机分为合用组（33例）和单用组（34例），分别给予西酞普兰（34．7±5．2）mg／d＋丁螺环酮（35．7±5．6）mg／d、单用西酞普兰（35．1±4．9）mg治疗，疗程均为8周，采用汉密顿抑郁量表（HAMD）、临床疗效总评量表（CGI）、副反应量表（TESS）评定疗效和不良反应。结果治疗8周后合用组HAMD，CGI评分下降较单用组更明显，起效更快，不良反应相仿且均较轻微。结论西酞普兰合并丁螺环酮是目前治疗难治性抑郁症的一种安全、有效的方法。     

Treatment of chronic posttraumatic stress disorder in combat veterans with citalopram: an open trial

Posttraumatic stress disorder (PTSD) is a serious mental illness which exhibits significant impairment of psychosocial and occupational function. At present, serotonin reuptake inhibitors (SRIs) show therapeutic promise for the treatment of PTSD. However, results in the veteran population have been less robust or often negative. In this study, a relatively new and the most selective SRI, citalopram, was evaluated for the treatment of PTSD. Veterans with chronic PTSD (N = 18) were enrolled in an 8-week open trial of citalopram after providing written informed consent. The primary outcome measures were the Clinician-Administered PTSD Scale (CAPS), the Hamilton Rating Scale for Anxiety (HAM-A), and the Clinical Global Impression Scale (CGI). Seventeen patients completed at least 4 weeks of the 8-week trial. During treatment, there was a moderate response with 42% of patients demonstrating a > or =30% reduction in total CAPS score at week 8. Comparable results were demonstrated in the Hamilton Depression Rating Scale (HAM-D), HAM-A, Global Assessment of Function (GAF), and CGI rating scales. In a follow-up analysis, a treatment effect was shown for CAPS B at week 4, but was not sustained at week 8. Overall, citalopram was generally well tolerated with reported adverse events being benign in nature. These pilot results demonstrate a moderate effect of citalopram in the treatment of combat-induced PTSD. However, the sample size was small and patient population is limited to veterans with combat-induced PTSD. Further study in a larger and more diverse patient sample is warranted prior to final conclusions on efficacy of citalopram for the treatment of PTSD.     

Subjective assessment of the effects of CNS-active drugs on sleep by the Leeds sleep evaluation questionnaire: a review

The Leeds sleep evaluation questionnaire (LSEQ) comprises ten self-rating 100 mm line analogue questions concerned with sleep and early morning behaviour. A literature search identified 83 studies in peer-reviewed journals that reported the use of the LSEQ for psychopharmacological investigations of drug effects on self-reported aspects of sleep. High internal consistency and reliability of the questionnaire have been demonstrated. Findings from studies involving a variety of psychoactive agents indicated that the LSEQ was able to quantify subjective impressions of sleep and waking and the effects of drugs in healthy volunteers, depressed and insomnia patients. In accordance with their known activity profile nocturnal administration of sedative hypnotic agents and antihistamines induced dose-related improvements in self-reported ease of getting to sleep, and quality of sleep but a decrease in alertness and behavioural integrity the following morning. Psychostimulants, on the other hand, impaired subjective ratings of sleep and increased early morning alertness. Antidepressants and certain anxiolytic agents improved both self-reported sleep aspects and early morning alertness. Treatment effects measured by the LSEQ corresponded to those measured for the same drugs by other assessment methods. These data indicate that the LSEQ is a robust and reliable instrument for psychopharmacological evaluations. Self-evaluations of sleep, as obtained by the LSEQ, can therefore provide consistent and meaningful measures for estimating the effectiveness of sleep modulators and sedative-hypnotic drugs.     

Mirtazapine in amphetamine detoxification: a placebo-controlled pilot study

The present study aimed to assess the safety and efficacy of mirtazapine in amphetamine detoxification in a 14-day randomized, placebo-controlled pilot trial in a Thai population. Subjects retained at a Specialized Probation Center, Department of Probation, Ministry of Justice, Thailand (n=20), who met DSM-IV criteria for amphetamine dependence and the inclusion criteria of the study, were randomized for either mirtazapine treatment or placebo. Efficacy was assessed by the Amphetamine Withdrawal Questionnaire (AWQ) for amphetamine withdrawal symptoms and the Montgomery-Asberg Depression rating scale (MADRS) for depression. Mirtazapine safety was assessed by interview during each follow-up period on days 3 and 14 after treatment. Nine subjects were randomized to the mirtazapine group and 11 to the placebo group. Among the initial 20 subjects, 16 (seven in the mirtazapine and nine in the placebo group) completed the study. There were significant improvements in the total AWQ score changes in the mirtazapine group versus placebo both at days 3 (P<0.005) and 14 (P<0.030). Significant improvements in favour of mirtazapine were also seen in the hyperarousal and the anxiety subscale score changes at days 3 (P<0.029) and 14 (P<0.018), respectively. No significant differences were seen (P>0.05) in the MADRS scores changes within or between the groups. Mild adverse events, such as headache, sedation, nausea and vomiting, were reported. In conclusion, despite its small sample size, this randomized, placebo-controlled pilot trial lends support to the hypothesis that mirtazapine may be an option in the meager armamentarium of amphetamine detoxification treatment.     

Cross-cultural validation of the Leeds sleep evaluation questionnaire (LSEQ) in insomnia patients

The Leeds sleep evaluation questionnaire (LSEQ) is a standardized self-reporting instrument comprising ten 100 mm visual analogue scales that pertain to the ease of getting to sleep (GTS), quality of sleep (QOS), ease of awakening from sleep (AFS) and alertness and behaviour following wakefulness (BFW). Although the LSEQ has been used in a variety of populations, published psychometric data on insomnia patients are limited. The LSEQ reliability and construct validity was evaluated in 396 French insomnia patients aged 55 years and over, who were treated with placebo (2 weeks) and melatonin (3 weeks). The results supported LSEQ internal consistency, reliability and construct validity with minor differences from those of the original English version. Then the internal consistency of the LSEQ was evaluated in 257 insomnia patients (age 20-80 years) in France and Israel who, following a 1 week placebo baseline, were randomized to placebo or melatonin treatment for 3 weeks. Cronbach's alpha and Pearson's r correlation coefficients for placebo and drug treatment conditions (p<0.001 for all) supported LSEQ internal consistency in different treatment and age groups and in different languages. It is concluded that the consistency, reliability and validity of the four LSEQ domains allows them to be singled out as independent outcome variables in cross cultural sleep research and clinical practice in adult and elderly patients with insomnia.     

西酞普兰与阿米替林治疗抑郁症的临床对照研究

目的:评价西酞普兰与阿米替林治疗抑郁症的临床疗效和安全性。方法:将55例符合CCMD-3抑郁症诊断标准的抑郁症患者随机分为两组,分别给予西酞普兰和阿米替林治疗,于治疗前和治疗后1、2、4、6周末分别采用汉密顿抑郁量表(HAMD)、临床疗效总体评定量表(CGI-SI)及不良反应量表(TESS)评定。结果:西酞普兰与阿米替林总体疗效相似,两组比较差异无显著性(P>0.05)。西酞普兰组治疗1周开始起效,两组治疗前后比较HAMD量表差异均有极显著性(P<0.01),治疗2、4、6周末两组之间比较差异无显著性(P>0.05),西酞普兰组的不良反应少于阿米替林组。结论:西酞普兰是一种安全有效的新一代抗抑郁药物。     

A randomized, double-blind, placebo-controlled study of citalopram in adolescents with major depressive disorder

In a European, multicenter, double-blind study, 244 adolescents, 13 to 18 years old, with major depression were randomized to treatment with citalopram (n = 124) or placebo (n = 120). One third of the patients in both groups withdrew from the study. No significant differences in improvement of scores from baseline to week 12 between citalopram and placebo were found. The response rate was 59% to 61% in both groups according to the Schedule for Affective Disorders and Schizophrenia for school-aged children-Present episode version (Kiddie-SADS-P) (depression and anhedonia scores < or =2) and Montgomery Asberg Depression Rating Scale (MADRS) (> or =50% reduction). Remission (MADRS score < or =12) was achieved by 51% of patients with citalopram and 53% with placebo. A post hoc analysis revealed that more than two thirds of all patients received psychotherapy during this study. For those patients not receiving psychotherapy, there was a higher percentage of Kiddie-SADS-P responders with citalopram (41%) versus placebo (25%) and a significantly higher percentage of MADRS responders and remitters with citalopram (52% and 45%, respectively) versus placebo (22% and 19%, respectively). Mild to moderate treatment-emergent adverse events were reported in 75% citalopram and 71% of placebo patients, most commonly headache, nausea, and insomnia. Serious adverse events occurred in 14% to 15% in both groups. Suicide attempts, including suicidal thoughts and tendencies, were reported by 5 patients in the placebo group and by 14 patients in the citalopram group (not significant) with no pattern with respect to duration of treatment, time of onset, or dosage. In contrast, the suicidal ideation (Kiddie-SADS-P) single item showed worsening more frequently in the placebo (18%) than in the citalopram group (8%).     

Faster onset of antidepressant effects of citalopram compared with sertraline in drug-naïve first-episode major depressive disorder in a Chinese population: a 6-week double-blind, randomized comparative study

Several previous studies, including a meta-analysis, reported no significant differences between various selective serotonin reuptake inhibitors (SSRIs) in the treatment of major depressive disorder. However, because of the different chemical structure of SSRIs and the difference in the frequency of serotonin transporter polymorphisms between ethnic groups, a head-to-head comparative study between SSRIs in different populations may be enlightening. We compared the efficacy and adverse effect profiles of citalopram and sertraline in a double-blinded randomized clinical trial in a Chinese population of drug-na?ve patients with first-episode major depressive disorder. Fifty-one patients were randomly assigned to citalopram or sertraline treatment. The Montgomery-?sberg Depression Rating Scale (MADRS) was used as the primary outcome. Efficacy and adverse effects were analyzed in an intent-to-treat population. Efficacy was analyzed using a last-observation-carried-forward method for early terminators. There were no significant differences in demographic characteristics at baseline. No significant differences were found in MADRS scores between citalopram and sertraline at baseline (36.6 ± 5.5 vs 38.2 ± 4.9; P = 0.322) or at the end of treatment (week 6; 10.8 ± 10.0 vs 16.7 ± 11.3; P = 0.082). However, MADRS scores in the citalopram group were significantly lower at week 1 (25.2 ± 8.5 vs 30.4 ± 6.1; P = 0.029) and week 3 (15.9 ± 10.0 vs 22.1 ± 8.7; P = 0.037). Overall, treatment-emergent adverse effects were reported by 14.3% and 28.6% of patients in the citalopram and sertraline groups, respectively. In conclusion, citalopram and sertraline were both efficacious and well tolerated. However, citalopram exhibited a significantly faster onset than sertraline during the early weeks of treatment and tended to have a better efficacy in overall treatment, although the statistic was not significant.     

心理干预对晚期肿瘤患者心理和生活质量的影响

目的 观察心理干预对晚期肿瘤患者心理和生活质量的影响.方法 回顾性分析2015年10月-2016年6月收治的79例晚期肿瘤患者的临床资料.接受心理干预者40例为观察组,未接受心理干预者39例为对照组.于入院时和心理干预2周后,对两组心理状况进行评价,包括抑郁自评量表(SDS)评分、焦虑自评量表(SAS)评分.两组生存质量评估采用健康调查简表(SF-36).结果 心理干预后观察组SDS评分和SAS评分均低于干预前和对照组(P＜0.05),SF-36各项目评分均高于干预前和对照组(P＜0.05).结论 心理干预措施能有效改善晚期肿瘤患者的心理状态,并提高其生活质量.     

Mirtazapine orally disintegrating tablets versus venlafaxine extended release: a double-blind, randomized multicenter trial comparing the onset of antidepressant response in patients with major depressive disorder

This randomized, multicenter, double-blind study was designed to compare specifically the onset of antidepressant action of mirtazapine orally disintegrating tablets (ODT) with venlafaxine extended-release (XR) formulation in outpatients with major depression. Both treatments were administered in a rapidly escalating dosing regimen. Target doses (mirtazapine ODT, 45 mg OD; venlafaxine XR, 225 mg OD) were reached by day 6 of treatment. On the primary efficacy parameter [the average of the change in HAM-D (17-item) total score on days 5, 8, 11, and 15], mirtazapine ODT was significantly superior to venlafaxine XR (P = 0.008). In addition, calculating the HAM-D score without the sleep items resulted in significant reductions in favor of mirtazapine ODT on days 8 (P = 0.006) and 11 (P = 0.037). The proportion of responders (HAM-D decrease of > or =50% from baseline) was higher in the mirtazapine ODT group on all assessment days, being significant on days 8 (P = 0.002), 11 (P = 0.004), and 22 (P = 0.027). More patients in the mirtazapine ODT group achieved remission (HAM-D total score of < or =7) up to day 29, and the difference was statistically significant on day 15 (P = 0.016). Significant differences in favor of mirtazapine ODT were evident in the CGI of change on days 8 (P = 0.019), 11 (P = 0.004), and 15 (P = 0.031), and the CGI of severity on days 8 (P = 0.014) and 11 (P = 0.033). Both treatments were well tolerated. These results indicate that mirtazapine ODT has a faster onset of antidepressant efficacy than venlafaxine XR in patients with major depressive disorder, and that this effect is independent of its sleep-improving properties.