Randomized double-blind study of fluvoxamine and maprotiline in treatment of depression

In a six-week double-blind randomized trial, preceded by a one-week period of single-blind placebo treatment, the efficacy and the side-effects of fluvoxamine (100-300 mg/d) (n = 24) and maprotiline (50-150 mg/d) (n = 24) were compared in moderately depressed outpatients with DSM-III Major Depression (n = 22) or Dysthymic Disorder (n = 26). Efficacy was measured by means of the Hamilton Depression Rating Scale, the Zung Depression Selfrating Scale, and a Clinical Global Impression of Severity Scale. Side-effects were evaluated by an Adverse Event Inventory and a Psychosomatic Symptom Scale. A statistically significant improvement was achieved in both treatment groups but success rates were modest: in both groups, 29% of the patients achieved a clinically significant improvement after six weeks of treatment. After six weeks of treatment, no difference in efficacy was found between fluvoxamine and maprotiline. Nausea was the most common complaint in the fluvoxamine group, while in the maprotiline group, it was dry mouth and constipation. One maprotiline-treated patient developed a convulsive attack.     

碳酸锂合并米氮平或氟西汀治疗双相抑郁的对照研究

目的评价米氮平合并碳酸锂治疗双相抑郁的疗效和安全性。方法将126例双相抑郁患者分为两组,研究组61例,应用米氮平合并碳酸锂,对照组65例,应用氟西汀合并碳酸锂,治疗8周。分别于治疗后第2、4、6、8周末用汉密尔顿抑郁量表(HAMD)和不良反应量表(TESS)比较两组的疗效和安全性。结果治疗后第2、4、6、8周末两组HAMD总分比较,差异均有显著性(P<0.05),研究组疗效优于对照组(P<0.05),两组脱落率比较差异有显著性(P<0.05),两组治疗后各时期TESS总分比较差异均无显著性(P>0.05),但研究组在治疗早期的嗜睡、困倦发生率较高、失眠发生率较低、胃肠道反应较少、治疗末体重增加较多(P均<0.05)。结论米氮平合并碳酸锂治疗双相抑郁疗效肯定,不良反应较少,依从性好。     

A double-blind, placebo-controlled study of venlafaxine and fluoxetine in geriatric outpatients with major depression.

BACKGROUND: Despite the high prevalence of depression in elderly patients, few well-designed, placebo-controlled studies of antidepressants have been conducted in this population. This masked, placebo-controlled trial assessed the efficacy and safety of venlafaxine and fluoxetine in depressed patients older than 65 years. METHOD: Three hundred patients were randomly assigned to treatment with venlafaxine immediate release ([IR]; N = 104), fluoxetine (N = 100), or placebo (N = 96) in an eight-week trial. Venlafaxine doses were titrated from 37.5 to 225 mg per day and fluoxetine doses were titrated from 20 to 60 mg per day, as necessary, over 29 days. Efficacy variables included the 21-item Hamilton Depression Rating Scale (HAM-D21) total score, HAM-D21 depressed mood item score, scores on the Montgomery Asberg Depression Rating Scale (MADRS), Clinical Global Impression-Severity of Illness (CGI-S) and Improvement (CGI-I) scales, and rates of response (based on change from baseline HAM-D or MADRS score or CGI-I score) and remission (HAM-D17 < or =7). For the purposes of this report, efficacy analyses are focused on the HAM-D21 total score. Safety assessments included monitoring of adverse events (AEs), physical examinations, vital signs assessments, laboratory determinations, and electrocardiograms. RESULTS: In all three of the treatment groups, there was a significant reduction at week 8 compared with the baseline HAM-D21 total score. However, there were no significant differences among the three treatment groups on the change in HAM-D21, MADRS, or CGI scores from baseline to week 8. There was no statistically significant difference in the proportion of remitters at the last on-therapy visit. The incidence of individual AEs was higher in the venlafaxine group (27%) compared with patients taking fluoxetine (19%) or placebo (9%). CONCLUSION: In this study, there was no significant difference in efficacy among placebo, venlafaxine, and fluoxetine for the treatment of depression.     

金玉康胶囊治疗轻、中度抑郁症的Ⅱ期临床研究

目的评价金玉康胶囊治疗轻中度抑郁症的临床疗效和安全性。方法对符合CCMD-3抑郁症诊断标准的59例抑郁症患者进行金玉康胶囊和氟西汀治疗的对照研究,其中金玉康胶囊组30例(600mg/d),氟西汀组29例(20mg/d),共治疗6周。采用汉密顿抑郁量表(HAMD),汉密顿焦虑量表(HAMA),临床总体评定量表(CGI)评定临床疗效,不良事件量表评定安全性。结果经6周治疗后,金玉康胶囊组总有效率为73.33%,氟西汀组为75.86%,两组比较差异无显著性(P>0.05)。两组的HAMD,HAMA评分治疗前后比较差异有极显著性(P<0.001)。两组药物不良反应的发生率无显著性差异(P>0.05)。结论金玉康胶囊治疗轻中度抑郁症疗效好,不良反应少而轻,适合临床应用。     

Efficacy and safety of morning versus evening fluoxetine administration

A total of 120 patients who met DSM-III criteria for unipolar major depressive episode were equally randomized to fluoxetine a.m. or fluoxetine p.m. treatment groups, such that 30 patients were in each group at each of two sites. Patients received 20 to 80 mg of fluoxetine every day for 5 weeks; the dose was based on clinical response. Highly significant within-treatment improvement was reflected by changes in mean scores on the Hamilton Rating Scale for Depression (total score and factors), the Raskin Depression Scale, the Covi Anxiety Scale, the Clinical Global Impressions Scale for Severity, and the Clinical Global Impressions Scale for Improvement. No significant differences occurred between the a.m. and p.m. groups for any efficacy variable. Evaluation of adverse events and vital signs indicated no clinically significant differences between the two treatment groups. The data indicate that fluoxetine is equally efficacious and well tolerated regardless of the time of day it is administered and suggest that fluoxetine may be administered at either time of day without affecting clinical course.     

盐酸安非他酮缓释片治疗抑郁症的Ⅱ期临床研究

目的评价盐酸安非他酮缓释片治疗抑郁症的临床疗效和安全性。方法对58例抑郁症患者进行盐酸安非他酮缓释片和氟西汀片的对照研究，其中盐酸安非他酮缓释片组29例（300mg／d），氟西汀组29例（20mg／d），共治疗6周。采用汉密尔顿抑郁量表（HAMD），汉密尔顿焦虑量表（HAMA），临床总体评定量表（CGI）评定临床疗效，不良事件量表评定安全性。结果经6周治疗后，盐酸安非他酮缓释片治疗总有效率为86．2％，氟西汀组为69．0％，两组比较差异无显著性（P〉0．05）。两组不良反应的发生率无显著性差异（P〉0．05），常见的不良反应有恶心、口干、头昏、出汗、食欲减退等。结论盐酸安非他酮缓释片是一种安全有效的抗抑郁药物。     

A double-blind, placebo-controlled comparison of venlafaxine and fluoxetine treatment in depressed outpatients

This double-blind, placebo-controlled study compared venlafaxine (immediate release), the first modern serotonin-norepinephrine reuptake inhibitor, with the selective serotonin reuptake inhibitor fluoxetine. Outpatients were randomly assigned to 6 weeks of treatment with venlafaxine (75-225mg/day; n=102), fluoxetine (20-60mg/day; n=104), or placebo (n=102). Efficacy was assessed using the 21-item Hamilton Depression Rating Scale (HAM-D(21)), the Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression-Severity of Illness (CGI-S) scale, response and remission rates, and several other measures. Intent-to-treat analyses utilized both the last observation carried forward and ETRANK methods to account for missing data. At week 6 or study endpoint, venlafaxine (mean dose: 142mg/day) was superior to placebo on most outcomes measures, whereas the differences between fluoxetine (mean dose: 41mg/day) and placebo were less consistent. Final remission (defined as HAM-D < or =7) rates were 32%, 28%, and 22% for venlafaxine, fluoxetine, and placebo, respectively. Few differences between the active treatments attained statistical significance. Both active therapies were generally well tolerated; however, attrition due to adverse events, incidence of selected side effects, and increases in pulse and blood pressure favored fluoxetine over venlafaxine. This study provides further evidence that venlafaxine is effective after 6 weeks of treatment compared with placebo. The efficacy profile of fluoxetine was somewhat less consistent. It is strongly recommended that future studies of comparative antidepressant efficacy be adequately powered to detect modest between-drug differences in efficacy.     

艾司西酞普兰与氟西汀治疗老年期抑郁症对照研究

目的观察艾司西酞普兰治疗老年期抑郁症的疗效和安全性。方法采用随机对照、开放标签设计,103例老年抑郁症患者随机分到艾司西酞普兰治疗组和氟西汀治疗组,治疗8周。汉密尔顿抑郁量表（HAMD）和汉密尔顿焦虑量表（HAMA）评估患者疗效,意向治疗分析法（Intent to Treat Analysis,ITT）处理研究数据。对中途退出或失访的病例按照末次观察推进法（Last Observation Carried Forward,LOCF）处理缺失值。结果治疗8周脱落率艾司西酞普兰组低于氟西汀组,差异有统计学显著性（21％：41％,χ^2=4．82,P〈0．028）;完成8周疗效观察的病例,艾司西酞普兰组有效率为90．3％;氟西汀组有效率86．6％,两组差异无统计学差异（χ^2=1．282,P=0．673）;ITT分析显示两组8周时疗效显著性差异,艾司西酞普兰治疗组抑郁和焦虑症状评分改善的时间早于氟西汀组,且不良反应率低于氟西汀组。结论艾司西酞普兰治疗老年抑郁症患者疗效和耐受性均优于氟西汀。     

A double-blind,randomized, group-comparative study of the tolerability and efficacy of 6 weeks' treatment with mirtazapine or fluoxetine in depressed Chinese patients

AIM: To compare the efficacy and tolerability of mirtazapine and fluoxetine treatment in a sample population consisting of Chinese patients suffering moderate-to-severe depression. METHOD: 133 patients with a diagnosis of major depressive episode (DSM-IV) and scoring 15 or more on the 17-item Hamilton Rating Scale for Depression (HAM-D) were randomly assigned to receive 6 weeks of treatment with either mirtazapine (15-45 mg/day) or fluoxetine (20-40 mg/day). Efficacy was assessed using the HAM-D and Clinical Global Impressions scale, with analyses performed on the intent-to-treat sample using the last-observation-carried-forward method. Safety analysis was based on the all-subjects-treated group. RESULTS: Mean daily doses were 34.1 mg for mirtazapine (N = 66) and 30.7 mg for fluoxetine (N = 66). Thirty patients in the mirtazapine group and 22 in the fluoxetine group dropped out. Both drugs proved equally effective for reduction of the overall symptoms of depression throughout the treatment period. At day 42, the mean reductions in HAM-D total score (compared with baseline) were 11.8 and 10.6 for the mirtazapine and fluoxetine groups, respectively; however, the changes were not statistically significant. Both treatments were well tolerated, with more nausea and influenza-like symptoms observed for the fluoxetine group, and greater weight increase and somnolence for the mirtazapine analog. CONCLUSION: Both mirtazapine and fluoxetine were indistinguishable in effectiveness for treatment of depressive symptoms, and both were well tolerated by our population of depressed Chinese patients. In line with analogous Western reports, the safety of mirtazapine and fluoxetine was comparable for our depressed Chinese patients; however, slightly different side effect profiles were noted for the 2 drugs in our study.     

A placebo-controlled,randomized trial of fluoxetine in the treatment of binge-eating disorder

BACKGROUND: The purpose of this study was to assess the efficacy and safety of fluoxetine in the treatment of binge-eating disorder. METHOD: Sixty outpatients with a DSM-IV diagnosis of binge-eating disorder were randomly assigned to receive either fluoxetine, 20 to 80 mg/day (N = 30), or placebo (N = 30) in a 6-week, double-blind, flexible-dose study. The primary measure of efficacy was frequency of binge eating. Secondary measures included body mass index, weight, Clinical Global Impressions-Severity of Illness score, Hamilton Rating Scale for Depression (HAM-D) score, and response categories. The outcome measures were analyzed using 2 random regression methods, a time trend analysis (primary analysis) and an endpoint analysis. In addition, response categories were analyzed using an exact trend test. RESULTS: Compared with placebo-treated subjects, subjects receiving fluoxetine (mean +/- SD endpoint dose = 71.3 +/- 11.4 mg/day) had a significantly greater reduction in frequency of binge eating (p =.033), body mass index (p <.0001), weight (p =.001), and severity of illness (p =.032) and a marginally significant reduction in HAM-D scores (p =.061). Differences between groups on response categories were not statistically significant. CONCLUSION: In a 6-week, placebo-controlled, flexible-dose trial, fluoxetine was efficacious in reducing binge-eating frequency, weight, and severity of illness and was generally well tolerated in subjects with binge-eating disorder.     

Fluoxetine versus trimipramine in the treatment of depression in geriatric patients

INTRODUCTION: Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), and trimipramine, a tricyclic antidepressant (TCA), were compared in terms of efficacy and tolerability in a six-week, parallel group, double-blind pilot study in 41 geriatric patients with major depression (61 - 85 years old). METHOD: The Hamilton Rating Scale for Depression (HAMD-17), the Montgomery-Asberg Rating Scale (MADRS), the Adjective Mood Scale (Bf-S), the Clinical Global Impression (CGI), and the Patients Global Impression (PGI) were used to measure changes in depressive symptoms. RESULTS: Improvement with treatment was found on all scales. Efficacy and tolerability were similar in both groups. No statistically significant differences were found. CONCLUSION: These findings suggest that fluoxetine and trimipramine are comparable in terms of efficacy and tolerability in the treatment of major depression in geriatric patients.     

阿戈美拉汀治疗首发抑郁症的临床效果

目的观察阿戈美拉汀治疗首发抑郁症的有效性及安全性。方法将76例首发抑郁症患者按照随机数字表法分为阿戈美拉汀组和氟西汀组各38例,分别以阿戈美拉汀25~50 mg/d和氟西汀20~40 mg/d治疗,两组均治疗6周。分别于治疗前及治疗第1、2、4、6周末采用汉密尔顿抑郁量表17项版(HAMD-17)评定临床疗效,于治疗6周末采用副反应量表(TESS)评定药物的安全性。结果阿戈美拉汀组有效率为86.84%,氟西汀组有效率为84.21%,两组差异无统计学意义(P0.05);在治疗第1、2周末,阿戈美拉汀组HAMD-17总评分及焦虑/躯体化、睡眠障碍因子评分均低于氟西汀组,差异均有统计学意义(P均0.05)。治疗6周末,两组TESS评分比较差异无统计学意义[(2.92±2.11)分vs.(3.42±2.13)分,P0.05]。结论阿戈美拉汀对首发抑郁症的疗效较好、安全性较高,尤其适用于伴有焦虑、失眠的抑郁症患者。     

氟西汀合并奥氮平治疗难治性抑郁症对照研究

目的探讨小剂量奥氮平合并氟西汀治疗难治性抑郁症的疗效和不良反应。方法将74例难治性抑郁症患者随机分为2组,研究组在氟西汀(20mg/d)治疗的同时合并应用奥氮平(5~10mg/d);对照组仅用氟西汀(20mg/d)治疗,两组作4周的持续治疗观察,于入组前及入组后第1、2、4周末分别用汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)及副反应量表进行评定。结果两组在治疗后第2、4周末,HAMD、HAMA总分及减分率的差异有统计学意义,两组间有效率的差异也有统计学意义。研究组和对照组分别有48.5%和38.9%出现不良反应,差异无统计学意义。结论小剂量奥氮平在难治性抑郁症的治疗中有增效作用,优于单用氟西汀,且安全性较好,在临床上可以作为治疗难治性抑郁症的一个备选方案。     

氟西汀与舍曲林治疗强迫症的比较研究

目的　比较氟西汀与舍曲林对强迫症的临床疗效及副反应。方法　将 5 8例强迫症患者随机分为两组 ,分别应用氟西汀和舍曲林治疗 ,疗程均为 10周 ,采用Yale Brown强迫量表 (Y BOCS)、汉密尔顿抑郁量表 (HAMD)、汉密尔顿焦虑量表 (HAMA)、副反应量表 (TESS)和临床疗效评定标准 ,分别评定临床疗效和副反应。结果　氟西汀组与舍曲林组疗效近似 ,氟西汀组显效率为 6 0 .71% ,有效率为 89.2 9% ,两组的显效率和有效率差异无显著性 (P >0 .0 5 ) ,且起效时间相近 ;各组治疗前、后Y BOCS、HAMD、HAMA总分比较差异有极显著性 (P <0 .0 1)。氟西汀组与舍曲林组副反应发生率差异无显著性 (P >0 .0 5 )。结论　氟西汀与舍曲林对强迫症均有较好的疗效 ,起效较快 ,副反应少 ,耐受性好     

电针治疗抑郁症临床观察及其机理的fMRI脑网络成像研究

目的观察醒脑开窍法电针治疗抑郁症的临床疗效及f MRI脑网络改变。方法采用随机数字表法将广州市惠爱医院门诊80例中重度抑郁症患者分为电针治疗组和假针对照组各40例,均治疗14天,对其进行治疗前后静息态f MRI检查,并于治疗前后评定汉密尔顿抑郁量表24项版(HAMD-24)、抑郁自评量表(SDS)及检验血浆ACTH、血清CORT水平的变化情况。结果 1临床疗效比较:治疗后,两组HAMD-24、SDS评分均较治疗前低,差异有统计学意义(P0.05),两组组间比较差异有统计学意义(P0.05),电针治疗组减分差值大于假针对照组;2血生化比较:治疗后两组血浆ACTH、血清CORT水平较治疗前低,同组治疗前后及组间比较差异均有统计学意义(P0.05);3脑功能活动比较:两组对抑郁症患者脑功能活动的影响存在差异。结论醒脑开窍法电针能有效调控中重度抑郁症患者的脑网络活动信号,调节内分泌功能,改善临床症状,提升机体的代偿功能及生存质量。     

CGP 12.103 A versus clomipramine in the treatment of depressed inpatients--results of a double-blind study

In a double-blind study, which was conducted as an interindividual comparison, 41 depressed inpatients were divided into two test groups according to a randomized list and received either the test substance CGP 12.103 A (19 patients) or the comparative substance clomipramine (22 patients). The study was conducted over a period of 28 days and the dosage of each substance, after being gradually increased, was stabilized at 150 mg. Except for a significantly varied distribution of syndrome patterns, the two treatment groups were comparable with regard to relevant criteria. Both treatment groups showed a significant improvement as assessed by both the degree of severity of depression and the Hamilton Depression Rating Scale; on each scale, however, the clomipramine treatment group exhibited a tendency toward better antidepressive efficacy. According to the self-evaluations of the patients, which were conducted with the help of v. Zerssen's Self-Rating Scale, this tendency was not significant. The Kusta activation parameter indicated a tendentially stronger manifestation in the case of clomipramine. In the final evaluation the onset of efficacy for the CGP 12.103 A group lay in the mean on treatment day 6, for the clomipramine group on treatment day 10. The physician's overall assessment of therapeutic effect found no differences between the two treatment groups on day 14 and on day 28. Expected side effects were observed in the CGP 12.103 A group in nine patients, in the clomipramine group in 14. All in all, the test substance CGP 12.103 A, the (-) or R-enantiomer of the antidepressant oxaprotiline, which itself is derived from maprotiline, showed no essential differences in its antidepressive efficacy compared with clomipramine.     

A double-blind comparison of mianserin and maprotiline in depressed medically ill elderly people

A double-blind, randomized 4-week mianserin vs maprotiline trial was conducted in 48 depressed geriatric medical inpatients. The drug dosages were up to 90 mg of mianserin and up to 150 mg of maprotiline per day. Efficacy was measured by the Geriatric Depression Scale, the Hopkins Symptom Check List depression subscale and the Clinical Global Impression Scale. The overall dropout figure was 27% of the sample. Side effects were relatively similar in the two treatment groups and suggested a safety profile somewhat better than that of the first-generation antidepressants. Mianserin showed some advantages in efficacy over maprotiline, particularly by the 4th week of the trial, but the overall figures of treatment responders were rather small (Geriatric Depression Scale: mianserin 48%, maprotiline 30%). Clinical trials vs placebo are needed to clarify the role of antidepressant pharmacotherapy in depressed geriatric medical inpatients.     

Antidepressant efficacy and quality of life in depression: a double-blind study with moclobemide and fluoxetine

The efficacy of moclobemide (300–450 mg7sol;day) was compared with fluoxetine (20–40 mg/day) in a double-blind, multicentre study in 209 patients with new episodes of depression selected from 612 consecutive depressed patients representative of those consulting psychiatric services in Finland. Antidepressant efficacy was assessed with the Hamilton Depression Rating Scale (HDRS), Montgomery-Åsberg Depression Rating Scale and Clinical Global Impression (CGI). The Medical Outcome Study Short-form General Health Survey (SF-20) and 15D Measure of Quality of Life were used to measure effectiveness in terms of health-related quality of life. Efficacy was evident with both drug treatments, with 67% in the moclobemide group and 57% in the fluoxetine group having a reduction in HDRS of more than 50%. Similarly, 77% of the patients in the moclobemide group and 67% in the fluoxetine group were assessed on the CGI as much better or very much better after 6 weeks of treatment. The most commonly reported adverse events were nausea, other gastrointestinal symptoms, nervousness, dizziness and sleep disorders. Nausea was significantly more common in the fluoxetine group and was found especially in women. Premature terminations of treatment were 18% in the moclobemide and 21% in the fluoxetine group. A significant change for the better in quality of life was found in both treatment groups, even at week 2 but especially after 6 weeks of treatment. Improvement was not only seen in dimensions measuring depression or mental health but also in other dimensions.     

A comparative study of suriclone, lorazepam and placebo in anxiety disorder

In a four-week double-blind randomized trial preceded by a one-week single-blind placebo treatment, the efficacy and the side-effects of suriclone (1.50-2.25 mg/d) (n = 24), lorazepam (5.0-7.5 mg/d) (n = 19) and placebo (n = 21) were compared in 64 outpatients with a DSM-III diagnosis of generalized anxiety disorder (n = 56) or panic disorder (n = 8). Efficacy was measured weekly by means of a global clinical impression scale, the Hamilton Anxiety Rating Scale, the Zung Anxiety Self-Assessment Scale and a target symptom scale. Side-effects were evaluated weekly by an adverse events scale, which recorded the spontaneous complaints and the complaints elicited by an extensive somatic inventory questionnaire. The three groups showed a statistically significant and clinically relevant improvement early on in the treatment: this improvement was maintained during the remaining period. Early on in the treatment there was some indication of a better response, but also of more side-effects, in the suriclone and the lorazepam groups. After four weeks of treatment no difference was found between the three groups either in efficacy or in side-effects. The effect size achieved in the placebo group was not inferior to that of benzodiazepines in general.