A Postmarketing Clinical Experience Study of Metadate® CD

Summary

Objective:The objective of the study was to investigate the effectiveness and safety of Metadate® CD (methylphenidate HCl, USP) Extended Release Capsules in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), in actual clinical practice.

Method:This was a multicenter, open-label, postmarketing study. Eligible patients were aged 6-17 with a diagnosis of ADHD and receiving either no treatment or maintenance treatment with another approved methylphenidate (MPH) product. Metadate® CD was administered once daily for 3 weeks, titrated against reported and observed symptoms. Clinical Global Impression (CGI) scores at Week 3 were used for the primary efficacy evaluation. Patient treatment satisfaction was determined by questionnaire at the final evaluation visit. Safety was assessed through adverse event reporting, laboratory tests and vital sign measurements.

Results: Overall, of the 308 patients in the Intent-To-Treat population, the majority (65%) demonstrated a positive response to Metadate® CD (defined as CGI Global Improvement rating of very much or much improved). In addition, patients previously treated with immediate-release or extended-release tablet formulations of MPH were successfully converted to Metadate® CD at a comparable dose. Most patients (87%) were very satisfied or moderately satisfied with study treatment, and among previously treated patients, 71% rated Metadate® CD as much better or better than their previous MPH treatment. Adverse events were consistent with current FDA-approved product labeling for Metadate® CD.

Conclusions: Metadate® CD is effective and well-tolerated in actual clinical use for ADHD.     

认知行为治疗对社区精神分裂症患者的疗效

目的:探讨认知行为治疗对社区精神分裂症患者的短期和长期疗效。方法:本研究为一项随机对照临床试验,纳入符合ICD-10精神分裂症诊断标准的患者32例,随机分成两组,分别接受常规治疗(TAU组,n=16)和常规治疗联合认知行为治疗(CBT组,n=16)。采用阳性与阴性症状量表(PANSS)和临床大体印象量表(CGI)于基线和治疗结束时分别对两组患者进行评定,并随访评估其半年和一年疗效。结果:112周、38周和64周时,CBT组PANSS总分显著低于TAU组(t=-2.174,-2.187,-3.256;P0.05);2在38周和64周时,CBT组阳性症状量表得分显著低于TAU组(t=-2.564,-2.146;P0.05);3在38周和64周时,CBT组一般精神病理症状量表分显著低于TAU组(P0.05);4CBT组的1年随访复发率显著低于TAU组(P0.025),而有效率显著高于TAU组(60.0%VS.20.0%,P=0.039)。结论:认知行为治疗可改善社区精神分裂症患者的症状及病情严重程度,尤其是阳性症状与焦虑抑郁等一般精神病理症状,降低复发率。     

度洛西汀与氟西汀治疗躯体形式障碍对照研究

目的：探讨度洛西汀与氟西汀治疗躯体形式障碍的临床疗效和安全性。方法将80例躯体形式障碍患者随机分为两组,研究组口服度洛西汀治疗,对照组口服氟西汀治疗,观察6周。于治疗前后采用临床疗效大体评定量表、症状自评量表的躯体化、焦虑、抑郁因子评定临床疗效,副反应量表评定不良反应。结果治疗6周末,研究组显效率69．2％、总有效率89．7％,对照组分别为44．4％、75．0％,研究组显效率显著高于对照组（χ2＝4．70,P＜0．05）,总有效率高于对照组,但差异无显著性（χ2＝2．84,P＞0．05）。治疗各时段副反应量表评分均显著低于对照组（P＜0．01）。结论度洛西汀与氟西汀治疗躯体形式障碍疗效均显著,但度洛西汀治疗起效更快、疗效更显著、安全性更高、依从性更好。     

Gender-specific associations of depression with positive and negative symptoms in acute schizophrenia

This clinical study analyzed gender-specific relationships of depression with other psychopathological and clinical variables in hospitalized patients with schizophrenia. During clinical routine treatment 119 inpatients with acute schizophrenia (DSM-IV) were investigated with the Calgary Depression Rating Scale for Schizophrenia (CDSS), the Clinical Global Impressions (CGI), and the Positive and Negative Syndrome Scale (PANSS). Depression scores of 77 male and 42 female patients (mean age 31.6+/-10.3 years) were related to background variables and to positive and negative symptom scores. Mean CDSS (5.8+/-5.6) and PANSS scores (total 76.9+/-22.1, positive symptoms 17.6+/-7.6, negative symptoms 20.5+/-7.8) were not significantly different between males and females. In females, depression was independently associated with higher negative symptom scores (P<0.01) and younger age (P<0.05) whereas in males positive symptoms (P<0.05) and short hospitalization (P<0.05) were the main factors associated with depression. The study revealed gender-specific differences in the relationship of depression with negative and positive symptoms.     

Basilar artery blood flow velocity changes in patients with panic disorder following 35% carbon dioxide challenge

PURPOSE: We compared the mean basilar artery blood flow velocity (BABFV) between patients with panic disorder and healthy subjects both at rest and immediately following carbon dioxide (CO(2)) challenge, and examined the effects of treatment on BABFV. METHODS: Twenty four patients with panic disorder with or without agoraphobia and 12 healthy comparison subjects were studied. Visual Analog Anxiety Scale was used to evaluate the anxiogenic effect of 35% CO(2) inhalation. Mean BABFV was monitored using transcranial Doppler ultrasonography at rest and 10, 20, 30, 60, 90, 120 s after 35% CO(2) challenge both before and after four weeks treatment with paroxetine. RESULTS: The hemodynamic response pattern of basilar artery to CO(2) inhalation was significantly different between two groups. CO(2) rapidly triggered blood flow velocity in basilar artery amongst panic patients but not in healthy comparisons. The mean time to normalization of BABFV was significantly longer in panic patients. Four weeks of treatment with paroxetine led to a significantly reduced mean BABFV after 35% CO(2) inhalation in comparison with pretreatment. CONCLUSIONS: Patients with panic disorder had impaired cerebral regulatory mechanisms observed as a change in response characteristics in BABFV in response to CO(2) inhalation. Treatment with paroxetine reduced the increase of BABFV seen in patients after the CO(2) challenge.     

Schizophrenia with prominent catatonic features ('catatonic schizophrenia'). II. Factor analysis of the catatonic syndrome

Previous factor analyses of catatonia have yielded conflicting results for several reasons including small and/or diagnostically heterogeneous samples and incomparability or lack of standardized assessment. This study examined the factor structure of catatonia in a large, diagnostically homogenous sample of patients with chronic schizophrenia using standardized rating instruments. A random sample of 225 Chinese inpatients diagnosed with schizophrenia according to DSM-IV criteria were selected from the long-stay wards of a psychiatric hospital. They were assessed with a battery of rating scales measuring psychopathology, extrapyramidal motor status, and level of functioning. Catatonia was rated using the Bush-Francis Catatonia Rating Scale. Factor analysis using principal component analysis and Varimax rotation with Kaiser normalization was performed. Four factors were identified with Eigenvalues of 3.27, 2.58, 2.28 and 1.88. The percentage of variance explained by each of the four factors was 15.9%, 12.0%, 11.8% and 10.2% respectively, and together they explained 49.9% of the total variance. Factor 1 loaded on "negative/withdrawn" phenomena, Factor 2 on "automatic" phenomena, Factor 3 on "repetitive/echo" phenomena and Factor 4 on "agitated/resistive" phenomena. In multivariate linear regression analysis negative symptoms and akinesia were associated with 'negative' catatonic symptoms, antipsychotic doses and atypical antipsychotics with 'automatic' symptoms, length of current admission, severity of psychopathology and younger age at onset with 'repetitive' symptoms and age, poor functioning and severity of psychopathology with 'agitated' catatonic symptom scores. The results support recent findings that four main factors underlie catatonic signs/symptoms in chronic schizophrenia.     

Cognitive dysfunctions in patients with obsessive-compulsive disorder compared to the patients with schizophrenia patients: relation to overvalued ideas

OBJECTIVE: The clinical overlaps between schizophrenia and obsessive-compulsive disorder (OCD) seem to be related to thought disorders involving obsessions, overvalued ideas, and delusions. Overvalued ideas are beliefs falling in between obsessions and delusions and are stronger than obsessions but weaker than delusions. The goal of the present study was to compare patients with OCD to those with schizophrenia in terms of cognitive functions and to relate cognition and overvalued ideas in OCD. METHODS: Twenty three patients with OCD (free of depression), 24 patients with schizophrenia, and 22 healthy subjects matched to patients in age, gender, education, and hand dominance were included in the study. All subjects were administered neurocognitive tests assessing verbal learning-memory, executive functions, verbal fluency, attention and verbal working memory. RESULTS: Patients with schizophrenia showed worse performance on cognitive tests than the OCD and control groups. The severity of overvalued ideas was significantly correlated to cognitive functions in the OCD group. There were no significant differences in cognitive functions between schizophrenia group and the OCD patients who had higher scores on the Overvalued Ideas Scale (OVIS). CONCLUSION: Overvalued ideas in OCD may be related to cognitive dysfunctions in OCD and this subtype of OCD may have similar characteristics to schizophrenia in terms of cognition.     

Serum levels of brain-derived neurotrophic factor in schizophrenia on a hypocaloric diet

Dietary factors influence BDNF in animal studies, but there is no comparable data in clinical populations. We examined the effect of a dietary intervention on BDNF serum levels in 67 DSM-IV schizophrenic outpatients (51 males and 16 females). Two groups were assessed in a cross-sectional study: one on a hypocaloric diet (HD) and the other not on a hypocaloric diet. Weight, height and BMI data were collected concurrently with 5-ml blood sampling of each subject. BDNF levels were measured with a sandwich-ELISA. The blood sample was obtained a minimum of one month after the exposure to dietary intervention. Serum BDNF levels were significantly higher in patients on the HD (p=0.023). Additional research examining the interaction among patterns of nutritional food behavior and underlying physiopathology may result in insights upon which evidence-based decisions regarding dietary interventions can be made in people identified with major psychiatric disorders, such as schizophrenia.     

氟西汀联合喹硫平治疗难治性抑郁症对照研究

目的 探讨氟西汀联合喹硫平治疗难治性抑郁症的l临床疗效与安全性.方法将58例难治性抑郁症患者随机分为研究组30例,对照组28例,两组均口服氟西汀治疗,研究组联合喹硫平治疗,对照组联合利培酮治疗,观察8周.于治疗前及治疗第2周、4周、6周,8周末采用汉密顿抑郁量表、临床总体印象量表评定临床疗效,副反应量表评定不良反应.结...