Modafinil Augmentation for Residual Symptoms of Fatigue in Patients with a Partial Response to Antidepressants

2007 ◽  
Vol 41 (6) ◽  
pp. 1005-1012 ◽  
Author(s):  
Jenny Y Lam ◽  
Maisha Kelly Freeman ◽  
Marshall E Cates
Keyword(s):  
Clinical Trials ◽  
Data Extraction ◽  
Controlled Clinical Trials ◽  
Open Label ◽  
Double Blind ◽  
Residual Symptoms ◽  
Randomized Controlled ◽  
Manual Search ◽  
Number Of Patients ◽  
Residual Fatigue

OBJECTIVE: To evaluate the literature discussing the use of modafinil in the treatment of residual symptoms of fatigue in patients with depression. DATA SOURCES: PubMed (1966–March 2007) and International Pharmaceutical Abstracts(1970–March 2007) were searched using the key words modafinil and depression. A manual search of the reference section of the articles retrieved was conducted to identify articles not indexed in either of these sources. STUDY SELECTION AND DATA EXTRACTION: All articles published in English were evaluated. Studies were included if modafinil was used to treat patients with residual fatigue from depression and the effects were measured with validated fatigue subscales. DATA SYNTHESIS: One retrospective study, 5 open-label trials, and 2 randomized controlled clinical trials met the inclusion criteria for assessment of residual symptoms of fatigue as assessed by commonly used fatigue subscales after modafinil administration. Although improvement with fatigue has occurred with modafinil therapy, literature regarding the topic is limited by the lack of well-controlled clinical trials. Modafinil does appear to improve residual fatigue with depression as evidenced by open-label trials; however, the efficacy of this agent has not been duplicated in randomized controlled trials. The open-label trials that have been conducted often had no comparator and a small number of patients. In addition, outcome measures used in the studies were not consistent between trials. Modafinil appears to be well tolerated, with the main adverse effects being headache and nausea. CONCLUSIONS: Open-label trials indicate that modafinil may be effective in ameliorating fatigue associated with depression; however, this effect has not been reproduced in randomized, double-blind, placebo-controlled clinical trials. Therefore, the use of modafinil for the treatment of residual fatigue is not recommended due to the lack of reproducible data of its efficacy. Long-term, adequately powered clinical trials should be conducted to determine its place in therapy.

scholarly journals Cytopenias among patients with rheumatic diseases using methotrexate: a meta-analysis of randomized controlled clinical trials

Rheumatology ◽  
2019 ◽  
Vol 59 (4) ◽  
pp. 709-717 ◽  
Author(s):  
Kathleen M M Vanni ◽  
Houchen Lyu ◽  
Daniel H Solomon
Keyword(s):  
Clinical Trials ◽  
Folic Acid ◽  
Rheumatic Diseases ◽  
Meta Analysis ◽  
Severe Neutropenia ◽  
Severe Thrombocytopenia ◽  
Controlled Clinical Trials ◽  
Double Blind ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

Abstract Objective To conduct a systematic literature review and meta-analysis to estimate the incidence of anaemia, leucopoenia, neutropenia and thrombocytopenia associated with MTX plus folic acid among patients with rheumatic diseases. Methods We searched MEDLINE, PubMed and EMBASE through August 2016 for all randomized controlled clinical trials with a MTX monotherapy arm. We excluded randomized controlled clinical trials for cancer and included only double-blind studies that reported on haematologic adverse events. Studies were excluded if patients did not receive folic acid or leucovorin supplementation. Full text articles were assessed by two independent reviewers. Incidence estimates were calculated using random-effects models. Results Of 1601 studies identified, 30 (1.87%) were included, representing 3858 patients; all had RA. Seventeen trials reported on anaemia (n = 2032), 17 reported on leucopoenia (n = 2220), 16 reported on neutropenia (n = 2202) and 12 reported on thrombocytopenia (n = 1507). The incidence for any anaemia was 2.55% (95% CI 0.60–5.47%), any leucopoenia 1.17% (95% CI 0.16–2.80%), any neutropenia 1.77% (95% CI 0.33–4.00%), and any thrombocytopenia 0.19% (95% CI 0.00–0.86%). Four cases of severe anaemia were reported, as defined by authors, along with three cases of severe neutropenia. No cases of severe leucopoenia, severe thrombocytopenia or pancytopenia were reported. Conclusion Cytopenias are an uncommon side effect of low-dose MTX with folic acid supplementation among RA patients. Further research is needed to reach a more precise estimate.

scholarly journals Intra-articular injections with corticosteroids and sodium hyaluronate for treating temporomandibular joint disorders: a systematic review

2013 ◽  
Vol 18 (5) ◽  
pp. 128-133 ◽  
Author(s):  
Eduardo Machado ◽  
Daniel Bonotto ◽  
Paulo Afonso Cunali
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Temporomandibular Joint ◽  
Sodium Hyaluronate ◽  
Temporomandibular Joint Disorders ◽  
Controlled Clinical Trials ◽  
Double Blind ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

INTRODUCTION: In some cases, conservative treatment of internal derangements of the Temporomandibular Joint (TMJ) is considered little responsive. Thus, it is necessary to accomplish treatments that aim at reducing pain and improve patients' functions who present arthrogenic temporomandibular disorders. OBJECTIVE: This study, by means of a systematic review of the literature, aimed to analyze the effectiveness of intra-articular injections with corticosteroids and sodium hyaluronate for treating internal derangements of the TMJ. METHODS: Carry out a research in the following databases: MEDLINE, Cochrane, EMBASE, Pubmed, Lilacs, and BBO, considering publications issued between 1966 and October of 2010, focusing on randomized or quasi-randomized controlled clinical trials, single or double-blind. RESULTS: After applying the inclusion criteria we collected 9 articles, 7 of which were randomized controlled double-blind clinical trials and 2 randomized controlled single-blind clinical trials. CONCLUSION: After analyzing the literature, it was found that intra-articular injection with corticosteroids and sodium hyaluronate seems to be an effective method for treating internal derangements of the TMJ. However, further randomized controlled clinical trials, with representative samples and longer follow-up time must be carried out in order to assess the real effectiveness of this technique.

Escitalopram Therapy for Major Depression and Anxiety Disorders

2007 ◽  
Vol 41 (10) ◽  
pp. 1583-1592 ◽  
Author(s):  
David S Baldwin ◽  
Elin Heldbo Reines ◽  
Christina Guiton ◽  
Emmanuelle Weiller
Keyword(s):  
Clinical Trials ◽  
Anxiety Disorders ◽  
Clinical Laboratory ◽  
Term Treatment ◽  
Controlled Clinical Trials ◽  
Short Term Treatment ◽  
Double Blind ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Long Term Treatment

Background: Randomized controlled clinical trials have demonstrated that escitalopram is efficacious in a range of mood and anxiety disorders, but the individual trials are insufficiently large to allow a full exploration of its tolerability. Objective: To assess (he tolerability and safety of escitalopram through analysis of all randomized controlled clinical trials in major depressive disorder and anxiety disorders. Methods: Analyses of tolerability were based on data from all available randomized, double-blind, controlled studies completed by December 2006 in which escitalopram was compared with placebo or active compounds (citalopram, fluoxetine, paroxetine, sertraline, venlafaxine). Adverse events (AEs) that occurred more frequently with escitalopram than with placebo were listed, and tolerability and safety were evaluated. Results: Nausea was the only AE with an incidence greater than or equal to 10% and 5 percentage points greater than with placebo during short-term treatment. In general, AEs were mild to moderate in severity. AEs related to sexual dysfunction were similarly frequent with escitalopram and Citalopram, but were higher with paroxetine. No suicide occurred among escitalopram-treated patients, and there were no significant differences between escitalopram and placebo in incidence of suicidal behavior, measured by self-harm and suicidal thoughts. The 8 week withdrawal rate due to AEs was higher with escitalopram than with placebo (7.3% vs 2.8%; p < 0,001) but lower than with paroxetine (6.6% vs 9.0%; p < 0.01) or venlafaxine (6.1% vs 13.2%; p < 0.01) (Fisher's Exact test, 2 tailed). Compared with paroxetine, escitalopram resulted in significantly fewer discontinuation symptoms (average increase in Discontinuation Emergent Signs and Symptoms Scale of 1.6 vs 3.9; p < 0.01). There were no clinically relevant changes in clinical laboratory values in patients treated with escitalopram. Mean weight change after 6 months of treatment with escitalopram (0.58 ± 2.63 kg) was similar to that with placebo (0.15 ± 2.33 kg). The incidence of cardiovascular events was similar to that with placebo. The risk of AEs was no higher in special patient populations, such as the elderly (≥65 y of age) or those with hepatic dysfunction. Conclusions: Based on data from randomized controlled trials involving more than 4000 escitalopram-treated patients, escitalopram (10–20 mg/day) is safe and well tolerated in short- and long-term treatment.

scholarly journals A brief review of antiviral drugs evaluated in registered clinical trials for COVID-19

2020 ◽  
Author(s):  
Drifa Belhadi ◽  
Nathan Peiffer-Smadja ◽  
François-Xavier Lescure ◽  
Yazdan Yazdanpanah ◽  
France Mentré ◽  
...  
Keyword(s):  
Stem Cells ◽  
Clinical Trials ◽  
Data Extraction ◽  
Antiviral Agents ◽  
Median Number ◽  
Antiviral Drugs ◽  
Open Label ◽  
Double Blind ◽  
Stem Cells Therapy ◽  
Novel Coronavirus

ABSTRACTBackgroundAlthough a number of antiviral agents have been evaluated for coronaviruses there are no approved drugs available. To provide an overview of the landscape of therapeutic research for COVID-19, we conducted a review of registered clinical trials.MethodsA review of currently registered clinical trials was performed on registries, including the Chinese (chictr.org.cn) and US (clinicaltrials.gov) databases to identify relevant studies up to March, 7th 2020. The search was conducted using the search terms “2019-nCoV”, “COVID-19”, “SARS-CoV-2”, “Hcov-19”, “new coronavirus”, “novel coronavirus”. We included interventional clinical trials focusing on patients with COVID-19 and assessing antiviral drugs or agents.FindingsOut of the 353 studies identified, 115 clinical trials were selected for data extraction. Phase IV trials were the most commonly reported study type (n=27, 23%). However, 62 trials (54%) did not describe the phase of the study. Eighty percent (n=92) of the trials were randomized with parallel assignment and the median number of planned inclusions was 63 (IQR, 36-120). Open-label studies were the most frequent (46%) followed by double-blind (13%) and single blind studies (10%). The most frequently assessed therapies were: stem cells therapy (n=23 trials), lopinavir/ritonavir (n=15), chloroquine (n=11), umifenovir (n=9), hydroxychloroquine (n=7), plasma treatment (n=7), favipiravir (n=7), methylprednisolone (n=5), and remdesivir (n=5). Remdesivir was tested in 5 trials with a median of 400 (IQR, 394-453) planned inclusions per trial, while stem cells therapy was tested in 23 trials, but had a median of 40 (IQR, 23-60) planned inclusions per trial. Lopinavir/ritonavir was associated with the highest total number of planned inclusions (2606) followed by remdesivir (2155). Only 52% of the clinical trials reported the treatment dose (n=60) and only 34% (n=39) the duration. The primary outcome was clinical in 76 studies (66%), virological in 27 (23%); radiological in 9 (8%) or immunological in three studies (3%).InterpretationNumerous clinical trials have been registered since the beginning of the COVID-19 outbreak, however, a number of information regarding drugs or trial design were lacking.FundingNone

Topiramate: A New Antiepileptic Drug

1997 ◽  
Vol 31 (10) ◽  
pp. 1164-1173 ◽  
Author(s):  
Michael D Privitera
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Antiepileptic Drug ◽  
Development Program ◽  
Clinical Effects ◽  
Controlled Clinical Trials ◽  
Psychomotor Slowing ◽  
Open Label ◽  
Double Blind ◽  
Label Data

OBJECTIVE: To review proposed mechanisms of action, clinical pharmacology, efficacy, safety, and tolerability of the antiepileptic drug (AED) topiramate. METHODS: All available data from the clinical development program — Published and unpublished data (provided by investigators or the RW Johnson Pharmaceutical Research Institute) — Were analyzed, with emphasis on the results of double-blind, placebo-controlled trials. Data from open-label studies provided information about long-term efficacy and tolerability. FINDINGS: Topiramate is highly effective in the control of previously therapy-resistant partial seizures, with or without secondary generalization. In the refractory adult patient population enrolled in controlled clinical trials, seizures were reduced by 50% or more in 27–47% of patients compared with 0–18% in placebo-treated patients and by 75% or more in 9–36% of the patients compared with 0–9% of those receiving placebo. The most common adverse effects involve the central nervous system and are mild to moderate in nature. Adverse effects include somnolence, fatigue, psychomotor slowing, and concentration problems. The currently recommended dosing is lower and titration slower than schedules used in the clinical trials; this may improve the tolerability of topiramate. Topiramate has few interactions with currently available AEDs, but phenytoin concentrations increased in some patients. Topiramate can be used initially as adjunctive therapy. Plasma topiramate concentrations are reduced substantially when used with enzyme-inducing AEDs. Open-label data and a single double-blind trial suggest that topiramate monotherapy may be effective. Open-label data also indicate that topiramate may be effective in generalized seizures of nonfocal origin, including those associated with Lennox-Gastaut syndrome. CONCLUSIONS: The robust clinical effects of topiramate expand the therapeutic options for patients with epilepsy. Controlled clinical trials are needed to verify initial observations that topiramate may be effective against a broad spectrum of seizure types and to directly compare efficacy and tolerability with other new and standard AEDs.

scholarly journals Cerebrolysin in Mild-to-Moderate Alzheimer's Disease: A Meta-Analysis of Randomized Controlled Clinical Trials

2015 ◽  
Vol 39 (5-6) ◽  
pp. 332-347 ◽  
Author(s):  
Serge Gauthier ◽  
Jefferson Voltaire Proaño ◽  
Jianping Jia ◽  
Lutz Froelich ◽  
Johannes Christophe Vester ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Cognitive Function ◽  
Meta Analysis ◽  
Controlled Clinical Trials ◽  
Clinical Change ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Controlled

Objective: The aim of this study was to provide a systematic and quantitative summary of benefit and risk of Cerebrolysin in patients with mild-to-moderate Alzheimer's disease (AD) and to avoid major deficiencies of an earlier meta-analysis. Design: This is a meta-analysis of randomized double-blind placebo-controlled clinical trials. Data Sources: Trials were identified with the help of PubMed, the Cochrane Dementia Group database, the Center for Collaborative Neurosciences, and references from reviews; no language restrictions were applied. Study Selection: All randomized double-blind placebo-controlled studies on 30 ml/day of Cerebrolysin in mild-to-moderate AD were included. Results: There were 6 eligible randomized controlled trials comparing Cerebrolysin with placebo. For all studies, either individual patient data and/or published data (aggregate data) were available. Analyses were based on the odds ratio (OR) for dichotomized global clinical change and for safety criteria, on the standardized mean difference (SMD) for pooling of cognitive function, and on the Mann-Whitney statistic (MW) for multivariate analysis of ‘global benefit' (combined effect of global clinical change and cognitive function). Cerebrolysin was significantly more effective than placebo at 4 weeks regarding cognitive function (4 weeks: SMD -0.40 points; 95% CI -0.66 to -0.13; p = 0.0031; 6 months: SMD -0.37 points; 95% CI -0.90 to 0.16; p = 0.1710), at 4 weeks and 6 months regarding global clinical change (4 weeks: OR 3.32; 95% CI 1.20-9.21; p = 0.0212; 6 months: OR 4.98; 95% CI 1.37-18.13; p = 0.0150), and at 4 weeks and 6 months regarding ‘global benefit' (combined efficacy criteria; 4 weeks: MW 0.57, 95% CI 0.53-0.61; p = 0.0006; 6 months: MW 0.57; 95% CI 0.53-0.61; p = 0.0010). The safety aspects of Cerebrolysin were comparable to placebo. Conclusion: This meta-analysis provides evidence that Cerebrolysin has an overall beneficial effect and a favorable benefit-risk ratio in patients with mild-to-moderate AD. Cerebrolysin as a therapeutic agent should be considered by clinicians seeking treatment options for mild-to-moderate AD.

scholarly journals Antidepressant drugs for older patients on polypharmacy: a systematic review reveals best evidence for sertraline

2018 ◽  
Vol 1 (1) ◽  
pp. 17-24 ◽  
Author(s):  
Matej Stuhec ◽  
Jordi Serra-Mestres
Keyword(s):  
Systematic Review ◽  
Older Adults ◽  
Clinical Trials ◽  
Older Patients ◽  
Treatment Guidelines ◽  
Antidepressant Drugs ◽  
Open Label ◽  
Double Blind ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractObjectivesThere is almost no data on antidepressant prescribing in older adults treated with polypharmacy, although this population represents approximately 50% of older patients. These patients are frequently excluded from double-blind randomized controlled trials, meta-analyses and existing treatment guidelines. The main aim of this paper was to identify data on antidepressant prescribing in depressed older adults on polypharmacy using a systematic review.MethodsRandomized controlled clinical trials (RCTs) and other clinical trials in Medline/PubMed without language limitation (-2017) were searched to identify those with older depressed patients on polypharmacy. Only elderly patients (>65 years as mean) were included. Only approved antidepressants were included.ResultsThe systematic search identified 26 different clinical trials, although only one clinical open label trial with sertraline met the final inclusion criteria. This sertraline trial indicated the absence of clinically important drug-drug interactions and confirmed the effectiveness and safety of sertraline in routine clinical practice. Heterogeneity in this trial was high in almost all the categories except attrition and reporting bias.ConclusionsSertraline has the highest evidence level in older adults with depression on polypharmacy. According to the results of this review and due to a low number of appropriate trials, a basic understanding of psychopharmacology is the possible approach to avoid serious problematic drug combinations in these patients. Newer RCTs are also urgently needed. This is the first systematic review including patients treated with polypharmacy, and therefore, its results are important in the field of evidence-based medicine.

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