scholarly journals Adverse reactions to antidepressants

2009 ◽  
Vol 195 (3) ◽  
pp. 202-210 ◽  
Author(s):  
Rudolf Uher ◽  
Anne Farmer ◽  
Neven Henigsberg ◽  
Marcella Rietschel ◽  
Ole Mors ◽  
...  
Keyword(s):  
Side Effect ◽  
Adverse Reactions ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Self Report ◽  
Open Label ◽  
Open Label Study ◽  
Adult Participants ◽  
Report Measure ◽  
Good Agreement

BackgroundAdverse drug reactions are important determinants of non-adherence to antidepressant treatment but their assessment is complicated by overlap with depressive symptoms and lack of reliable self-report measures.AimsTo evaluate a simple self-report measure and describe adverse reactions to antidepressants in a large sample.MethodThe newly developed self-report Antidepressant Side-Effect Checklist and the psychiatrist-rated UKU Side Effect Rating Scale were repeatedly administered to 811 adult participants with depression in a part-randomised multicentre open-label study comparing escitalopram and nortriptyline.ResultsThere was good agreement between self-report and psychiatrists' ratings. Most complaints listed as adverse reactions in people with depression were more common when they were medication-free rather than during their treatment with antidepressants. Dry mouth (74%), constipation (33%) and weight gain (15%) were associated with nortriptyline treatment. Diarrhoea (9%), insomnia (36%) and yawning (16%) were more common during treatment with escitalopram. Problems with urination and drowsiness predicted discontinuation of nortriptyline. Diarrhoea and decreased appetite predicted discontinuation of escitalopram.ConclusionsAdverse reactions to antidepressants can be reliably assessed by self-report. Attention to specific adverse reactions may improve adherence to antidepressant treatment.

Effectiveness of mirtazapine as add-on to paroxetine v. paroxetine or mirtazapine monotherapy in patients with major depressive disorder with early non-response to paroxetine: a two-phase, multicentre, randomized, double-blind clinical trial

2020 ◽  
pp. 1-9 ◽  
Author(s):  
Le Xiao ◽  
Xuequan Zhu ◽  
Amy Gillespie ◽  
Yuan Feng ◽  
Jingjing Zhou ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Additional Treatment ◽  
Combination Group ◽  
Open Label ◽  
Major Depressive ◽  
Double Blind ◽  
Early Improvement

Abstract Background This study aimed to examine the efficacy of combining paroxetine and mirtazapine v. switching to mirtazapine, for patients with major depressive disorder (MDD) who have had an insufficient response to SSRI monotherapy (paroxetine) after the first 2 weeks of treatment. Methods This double-blind, randomized, placebo-controlled, three-arm study recruited participants from five hospitals in China. Eligible participants were aged 18–60 years with MDD of at least moderate severity. Participants received paroxetine during a 2-week open-label phase and patients who had not achieved early improvement were randomized to paroxetine, mirtazapine or paroxetine combined with mirtazapine for 6 weeks. The primary outcome was improvement on the Hamilton Rating Scale for Depression 17-item (HAMD-17) scores 6 weeks after randomization. Results A total of 204 patients who showed early non-response to paroxetine monotherapy were randomly assigned to receive either mirtazapine and placebo (n = 68), paroxetine and placebo (n = 68) or mirtazapine and paroxetine (n = 68), with 164 patients completing the outcome assessment. At week 8, the least squares (LS) mean change of HAMD-17 scores did not significantly differ among the three groups, (12.98 points) in the mirtazapine group, (12.50 points) in the paroxetine group and (13.27 points) in the mirtazapine plus paroxetine combination group. Participants in the paroxetine monotherapy group were least likely to experience adverse effects. Conclusions After 8 weeks follow-up, paroxetine monotherapy, mirtazapine monotherapy and paroxetine/mirtazapine combination therapy were equally effective in non-improvers at 2 weeks. The results of this trial do not support a recommendation to routinely offer additional treatment or a switch in treatment strategies for MDD patients who do not show early improvement after 2 weeks of antidepressant treatment.

Hostility Conflict and Reporting of Side Effects by Psychiatric Outpatients

1980 ◽  
Vol 47 (1) ◽  
pp. 319-324 ◽  
Author(s):  
Robert W. Downing ◽  
Karl Rickels
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Self Report ◽  
Partial Replication ◽  
Drug Trials ◽  
Psychiatric Outpatients ◽  
Double Blind ◽  
The Relationship ◽  
Report Measure

The Irritability, Indirect Hostility, Verbal Hostility, and Resentment scales from the Buss-Durkee Hostility Inventory, along with a newly constructed scale intended as a self-report measure of Hostility Conflict, were administered to 84 non-psychotic, primarily anxious psychiatric outpatients receiving an active anxiolytic and participating in one of several 4-wk. double-blind drug trials. Patients who complained of one or more side effects after 2 wk. of treatment were classified as side reactors; the remaining patients, as non-side reactors. Compared to non-side reactors, the side reactors obtained higher hostility conflict scores and lower scores on the Irritability and Indirect Hostility scales. Also, the relationship between side effect status and hostility conflict was stronger in those patients who obtained higher scores on the Irritability, Indirect Hostility, and Verbal Hostility scales and among patients obtaining lower scores on the Resentment scale. Findings were regarded as providing partial replication of and further verification of earlier results.

scholarly journals Pilot trial on the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration: A single-arm, open-label study.

2020 ◽  
Author(s):  
Xuting Chang ◽  
Jie Zhang ◽  
Yuwu Jiang ◽  
Bufan Yao ◽  
Jingmin Wang ◽  
...  
Keyword(s):  
Rating Scale ◽  
Pilot Trial ◽  
Motor Dysfunction ◽  
Efficacy And Safety ◽  
Open Label ◽  
Pantothenate Kinase ◽  
Open Label Study ◽  
Label Study ◽  
Video Assessment

Abstract Objective This study aimed to explore the efficacy and safety of pantethine in children with pantothenate kinase-associated neurodegeneration (PKAN).Methods A single-arm, open-label study was conducted. All subjects received pantethine during the 24-week period of treatment. The primary endpoints were change of the Unified Parkinson’s Disease Rating Scale (UPDRS) I–III and Fahn–Marsden (FM) score from baseline to week 24 after treatment.Results Fifteen children with PKAN were enrolled, and all patients completed the study. After 24 weeks of treatment with pantethine at 60 mg/kg per day, there was no difference in either UPDRS I–III (t = 0.516, P = 0.614) or FM score (t = 0.353, P = 0.729) between the baseline and W24. Whereas the rates of increase in UPDRS I-III (Z = 2.614, p = 0.009) and FM scores (Z = 2.643, p = 0.008) were slowed. Four patients (26.7%) were evaluated as “slightly improved” by doctors through blinded video assessment. Patients with lower baseline UPDRS I–III or FM scores were more likely to be improved. The living quality of family members improved after pantethine treatment, evaluated by PedsQL TM 2.0 FIM scores, whereas the living quality of the patients was unchanged at W24, evaluated by PedsQL TM 4.0 and PedsQL TM 3.0 NMM. Serum level of CoA was comparable between baseline and W24. There was no drug related adverse event during the study.Conclusions Pantethine could not significantly improve motor function in children with PKAN after 24 weeks treatment, but it could probably delay the progression of motor dysfunction in our study. 26.7% of patients showed slightly improved. Pantethine was well-tolerated at 60 mg/kg per day.

scholarly journals A comparative prospective open label randomized controlled 8 week study in patients of depression treated with vilazodone and sertraline

2020 ◽  
Vol 7 (4) ◽  
pp. 643
Author(s):  
Nirmal Arya ◽  
Anuradha Nischal ◽  
Anil Nischal ◽  
Manu Agarwal
Keyword(s):  
Side Effect ◽  
Rating Scale ◽  
Sexual Experience ◽  
Open Label ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Treatment Of Depression ◽  
Group A ◽  
Hamilton Anxiety Rating Scale ◽  
Group B

Background: Depression is a mood disorder treated with various antidepressant such as SSRIs due to lesser toxicity and improved safety profile.Methods: This was an eight week randomised active controlled parallel group study. 54 patients were allocated in two group. Group A received vilazodone while group B received sertraline. Assessment done at baseline, 2, 4 and 8 weeks on the basis of clinical efficacy, sexual dysfunction, side effects and weight gain using Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Arizona Sexual Experience Scale (ASEX) and UKU Side Effect Rating Scale.Results: HAM-D score of group A was 18.78±1.78 and 7.67±1.66 while in group B was 19.04±2.12 and 8.15±1.77 at baseline and 8 weeks respectively. HAM-A score of group A was 15.44±1.50 and 6.63±1.39 while in group B was 15.26±1.83 and 7.07±1.14 at baseline and 8 weeks. ASEX total score of group A was 15.63±1.28 and 14.63±1.33 while group B was 15.52±1.37 and 16.41±1.12 at baseline and 8 weeks. ASEX desire score of group A was 9.63±0.93 and 8.67±0.88 while of group B was 9.59±0.93 and 10.07±0.92 at baseline and 8 weeks. UKU side effect rating at 2 and 8 weeks of group A was 0.22±0.42, 1.04±0.76 while in group B was 0.37±0.49, 1.89±0.85.Conclusions: Vilazodone and Sertraline are equally efficacious in treatment of depression and associated anxiety. When side effect profile were compared Vilazodone is found superior to Sertraline

The Child Rating Scale and its Use with Middle School-Age Students

2000 ◽  
Vol 87 (2) ◽  
pp. 381-388
Author(s):  
Winston J. Hagborg
Keyword(s):  
Middle School ◽  
Convergent Validity ◽  
Rating Scale ◽  
Self Report ◽  
School Age ◽  
Acting Out ◽  
Rule Compliance ◽  
Psychological Sense ◽  
Scale Design ◽  
Report Measure

The Child Rating Scale is a socioemotional self-report rating scale design for elementary school children. This study examined the Child Rating Scale with a middle school-age sample (Grades 5 to 8) of 240 students. The Child Rating Scale's four scales have shown moderate to high coefficients alpha. Factor analysis yielded the 4 underlying factors consistent with the current subscales. Supportive convergent validity was found based on the Child Rating Scale subscales' predicted association with the Self-perception Profile for Children and the Psychological Sense of School Membership–Brief. Consistent with current research, decline over grades in rule compliance/acting out and school interest was documented as well as the expected mean sex differences on these two subscales. Possible areas of study are indicated, and the present study's limitations are described. The Child Rating Scale seems to be a promising self-report measure for middle school-age youth.

Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study

2015 ◽  
Vol 94 (2) ◽  
pp. 187-193 ◽  
Author(s):  
Young Woo Ryu ◽  
Song Won Lim ◽  
Jung Hoon Kim ◽  
Seung Hyun Ahn ◽  
Jae Duck Choi
Keyword(s):  
Postural Hypotension ◽  
Adverse Reactions ◽  
Prostate Volume ◽  
Prostatic Hyperplasia ◽  
Efficacy And Safety ◽  
Serenoa Repens ◽  
Open Label ◽  
Open Label Study ◽  
Equivalent Efficacy ◽  
Storage Symptom

Introduction: In Korea, increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH. Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies. The present study was designed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH. Materials and Methods: One hundred forty men with symptomatic BPH (IPSS ≥10) were recruited in our hospital for a 12-month, open-label, randomized trial. Patients were randomly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day (n = 60) or tamsulosin 0.2 mg/day only (n = 60). Prostate volume and PSA were measured at baseline and at end-point, whereas total IPSS, and its storage and voiding subscores, LUTS-related QoL, Qmax, and PVR were evaluated at baseline and later every 6 months. Results: Total 103 patients were finally available: 50 in the TAM + SR group and 53 in the TAM group. At 12 months, total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM (p = 0.693); the storage symptoms improved significantly more with TAM + SR (-1.7 vs. -0.8 with TAM, p = 0.024). This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months (-1.9 vs. -0.9, p = 0.024). The changes of voiding subscore, LUTS-related QoL, Qmax, PVR, PSA, and prostate volume showed no significant differences between the TAM + SR and TAM groups. During the treatment period, 8 patients (16.9%) with TAM and 10 (20%) with TAM + SR had drug-related adverse reactions, which included ejaculatory disorders, postural hypotension, dizziness, headache, gastro-intestinal disorders, rhinitis, fatigue and asthenia. Conclusions: The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment.

Paliperidone in the treatment of delirium: results of a prospective open-label pilot trial

2011 ◽  
Vol 23 (4) ◽  
pp. 179-183 ◽  
Author(s):  
Ho-Kyoung Yoon ◽  
Yong-Ku Kim ◽  
Changsu Han ◽  
Young-Hoon Ko ◽  
Heon-Jeong Lee ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Rating Scale ◽  
Small Sample Size ◽  
Pilot Trial ◽  
Small Sample ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Before And After ◽  
The Status

Yoon H-K, Kim Y-K, Han C, Ko Y-H, Lee H-J, Kwon D-Y, Kim L. Paliperidone in the treatment of delirium: results of a prospective open-label pilot trial.Objective: Delirium is a life-threatening neuropsychiatric syndrome characterised by disturbances in consciousness, attention, cognition and perception. Antipsychotics are considered the drugs of choice in managing the symptoms of delirium. Paliperidone is a benzisoxazole derivative and the principal active metabolite of risperidone. In this study, we aimed to evaluate the efficacy of paliperidone for the treatment of delirium.Methods: A prospective open-label study of paliperidone for delirium treatment was performed with 6-day follow-up. Fifteen patients who met Diagnostic and Statistical Manual of Mental disorders, Fourth Edition criteria for delirium and had a score of 13 on the Delirium Rating Scale were recruited. The starting dose was 3 mg once a day and the dose was adjusted depending on the status of delirium. Daily assessments of the severity of delirium were evaluated using Memorial Delirium Assessment Scale (MDAS).Results: The mean daily maintenance dose of paliperidone was 3.75 ± 1.06. The MDAS scores before and after treatment (day 7) were 23.60 ± 6.31 and 11.33 ± 5.45 (t = 6.78, p < 0.001), respectively. The intensity of delirium showed a statistically significant reduction in MDAS scores from the first day of treatment. No serious adverse effects were observed, and none of the patients discontinued paliperidone because of adverse effects.Conclusions: This study shows that low-dose paliperidone is effective in reducing behavioural disturbances and symptoms in delirium and is well tolerated in delirious patients. This trial is an open-label study with a small sample size, and further controlled studies will be necessary.

Effectiveness and Duration of Effect of Open-Label Lisdexamfetamine Dimesylate in Adults With ADHD

2016 ◽  
Vol 21 (2) ◽  
pp. 149-157 ◽  
Author(s):  
Lenard A. Adler ◽  
Lauren R. Lynch ◽  
David M. Shaw ◽  
Samantha P. Wallace ◽  
Katherine E. O’Donnell ◽  
...  
Keyword(s):  
Adult Adhd ◽  
Rating Scale ◽  
Reliability And Validity ◽  
Self Report ◽  
Adhd Medication ◽  
Symptom Checklist ◽  
Symptom Scale ◽  
Open Label ◽  
Lisdexamfetamine Dimesylate ◽  
Duration Of Effect

Objectives: (a) Evaluate the efficacy and duration of effect of lisdexamfetamine dimesylate (LDX) in adult ADHD. (b) Assess the reliability and validity of the Adult ADHD Medication Smoothness of Effect Scale (AMSES) and Adult ADHD Medication Rebound Scale (AMRS). Method: Adults ( N = 40) with ADHD were treated with LDX for up to 12 weeks. The primary efficacy measure was the ADHD Rating Scale (ADHD-RS). The psychometric properties of the AMSES and AMRS are analyzed and compared with the ADHD-RS, ADHD Self-Report Scale (ASRS) v1.1 Symptom Checklist, and Time-Sensitive ADHD Symptom Scale (TASS). Results: ADHD-RS scores were significantly improved with LDX. The AMSES and AMRS had high internal consistency and were correlated with the ADHD-RS, ASRS v1.1 Symptom Checklist, and TASS. Conclusion: LDX is effective in treating adult ADHD and has a smooth drug effect throughout the day with limited symptom rebound. The AMSES and AMRS are valid and reliable measures.

scholarly journals LSVT-BIG Improves UPDRS III Scores at 4 Weeks in Parkinson’s Disease Patients with Wearing Off: A Prospective, Open-Label Study

2017 ◽  
Vol 2017 ◽  
pp. 1-4 ◽  
Author(s):  
Tatsuya Ueno ◽  
Megumi Sasaki ◽  
Haruo Nishijima ◽  
Yukihisa Funamizu ◽  
Tomoya Kon ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Rating Scale ◽  
Open Label ◽  
Advanced Parkinson’S Disease ◽  
Open Label Study ◽  
Motor Disability ◽  
Before And After ◽  
Disease Rating ◽  
Wearing Off

The efficacy of LSVT-BIG for advanced Parkinson’s disease (PD) patients with wearing off remains to be determined. Therefore, we evaluated whether LSVT-BIG improves motor disability in eight PD patients with wearing off. Unified Parkinson’s Disease Rating Scale (UPDRS) scores, daily off time, and mobility assessments were evaluated during the “on” time before and after the LSVT-BIG course. LSVT-BIG significantly improved UPDRS III scores at 4 weeks and UPDRS II scores in the “off” state at 12 weeks, with no changes in the other measures. The findings suggest that LSVT-BIG may be an effective therapy for advanced PD patients with wearing off.

scholarly journals Effects of chronic l-theanine administration in patients with major depressive disorder: an open-label study

2016 ◽  
Vol 29 (2) ◽  
pp. 72-79 ◽  
Author(s):  
Shinsuke Hidese ◽  
Miho Ota ◽  
Chisato Wakabayashi ◽  
Takamasa Noda ◽  
Hayato Ozawa ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Cognitive Functions ◽  
Verbal Memory ◽  
Rating Scale ◽  
Stroop Test ◽  
Open Label ◽  
Major Depressive ◽  
Open Label Study ◽  
Label Study

Objectivel-theanine, an amino acid uniquely contained in green tea (Camellia sinensis), has been suggested to have various psychotropic effects. This study aimed to examine whether l-theanine is effective for patients with major depressive disorder (MDD) in an open-label clinical trial.MethodsSubjects were 20 patients with MDD (four males; mean age: 41.0±14.1 years, 16 females; 42.9±12.0 years). l-theanine (250 mg/day) was added to the current medication of each participant for 8 weeks. Symptoms and cognitive functions were assessed at baseline, 4, and 8 weeks after l-theanine administration by the 21-item version of the Hamilton Depression Rating Scale (HAMD-21), State-Trait Anxiety Inventory (STAI), Pittsburgh Sleep Quality Index (PSQI), Stroop test, and Brief Assessment of Cognition in Schizophrenia (BACS).ResultsHAMD-21 score was reduced after l-theanine administration (p=0.007). This reduction was observed in unremitted patients (HAMD-21>7; p=0.004) at baseline. Anxiety-trait scores decreased after l-theanine administration (p=0.012) in the STAI test. PSQI scores also decreased after l-theanine administration (p=0.030) in the unremitted patients at baseline. Regarding cognitive functions, response latency (p=0.001) and error rate (p=0.036) decreased in the Stroop test, and verbal memory (p=0.005) and executive function (p=0.016) were enhanced in the BACS test after l-theanine administration.ConclusionOur study suggests that chronic (8-week) l-theanine administration is safe and has multiple beneficial effects on depressive symptoms, anxiety, sleep disturbance and cognitive impairments in patients with MDD. However, since this is an open-label study, placebo-controlled studies are required to consolidate the effects.

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