The Journal of clinical psychiatry
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Review Meta Analysis Comparative Study
Does randomized evidence support sertraline as first-line antidepressant for adults with acute major depression? A systematic review and meta-analysis.
Preliminary evidence suggested that sertraline might be slightly superior to other antidepressant medications in terms of efficacy. The aim of this study was to carry out a systematic review and meta-analysis to compare sertraline with any other antidepressant in the acute phase treatment of major depression at 8 weeks. ⋯ The results of this review suggest that sertraline may be a candidate as the initial choice of antidepressant for people with major depression.
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Historical Article
The history and current state of antidepressant clinical trial design: a call to action for proof-of-concept studies.
The development of new antidepressant drugs has reached a plateau. There is an unmet need for faster, better, and safer medications, but as placebo-response rates rise, effect sizes shrink, and more studies fail or are negative, pharmaceutical companies are increasingly reluctant to invest in new drug development because of the risk of failure. In the absence of an identifiable human pathophysiology that can be modeled in preclinical studies, the principal point of leverage to move beyond the present dilemma may be improving the information gleaned from well-designed proof-of-concept (POC) studies of new antidepressant drugs with novel central nervous system effects. With this in mind, a group of experts was convened under the auspices of the University of Arizona Department of Psychiatry and Best Practice Project Management, Inc. ⋯ The participants concluded that the federal government, academic centers, and the pharmaceutical industry need to collaborate on establishing a network of sites at which small, POC studies can be conducted and resulting data can be shared. New technologies to analyze and measure the major affective, cognitive, and behavioral components of depression in relationship to potential biomarkers of response should be incorporated. Standard assessment instruments should be employed across studies to allow for future meta-analyses, but new instruments should be developed to differentiate subtypes and symptom clusters within the disorder that might respond differently to treatment. Better early-stage POC studies are needed and should be able to amplify the signal strength of drug efficacy and enhance the quality of information in clinical trials of new medications with novel pharmacologic profiles.
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Review Meta Analysis Comparative Study
Mirtazapine versus other antidepressants in the acute-phase treatment of adults with major depression: systematic review and meta-analysis.
To conduct a comprehensive, systematic review and meta-analysis of the efficacy and tolerability of mirtazapine over other antidepressants in the acute-phase treatment of major depression. ⋯ Although mirtazapine is likely to have a faster onset of action than SSRIs, no significant differences were observed at the end of 6 to 12 weeks' treatment. Clinicians should focus on other practically relevant considerations to tailor treatment to best fit the needs of individual patients.
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Randomized Controlled Trial Multicenter Study
Triple-bead mixed amphetamine salts (SPD465), a novel, enhanced extended-release amphetamine formulation for the treatment of adults with ADHD: a randomized, double-blind, multicenter, placebo-controlled study.
The efficacy and safety of triple-bead mixed amphetamine salts (MAS), an oral, once-daily, enhanced extended-release amphetamine formulation designed for a duration of action up to 16 hours, were evaluated in adults with attention-deficit/hyperactivity disorder (ADHD). ⋯ Triple-bead MAS was significantly more effective than placebo in treating adult ADHD. The extended duration of action up to 16 hours and significant improvements in executive function and QOL address unique treatment needs of adults with ADHD. Treatment-emergent AEs with triple-bead MAS were consistent with amphetamine treatment.