The Journal of clinical psychiatry
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Randomized Controlled Trial Multicenter Study
Maintenance of efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: randomized withdrawal design.
To evaluate lisdexamfetamine dimesylate maintenance of efficacy in adults with attention-deficit/hyperactivity disorder (ADHD). ⋯ In adults with ADHD on medium- to long-term treatment, lisdexamfetamine dimesylate demonstrated maintenance of efficacy vs placebo upon randomized withdrawal. A majority of patients given placebo showed symptom relapse by 2 weeks. The safety profile of lisdexamfetamine dimesylate was generally consistent with previous lisdexamfetamine dimesylate studies.
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Randomized Controlled Trial Comparative Study
A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression.
Numerous double-blind studies have assessed the efficacy of antidepressants in treating chronic depressive disorder, including dysthymic disorder, low-grade chronic depression. However, there are no double-blind, placebo-controlled studies of serotonin-norepinephrine reuptake inhibitors in chronic depressive disorder. ⋯ Results on the 24-item HDRS, CGI, and CDRS suggest that duloxetine is efficacious in acute treatment of chronic nonmajor depressive disorder. Response and remission rates also differed significantly, favoring duloxetine treatment, but BDI, GAF, and social functioning (Social Adjustment Scale) did not. Duloxetine appears to be effective in acute treatment of nonmajor chronic depression.
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Comparative Study
Public and nonprofit funding for research on mental disorders in France, the United Kingdom, and the United States.
To document the investments made in research on mental disorders by both government and nonprofit nongovernmental organizations in France, the United Kingdom, and the United States. ⋯ Funding for research on mental disorders accounts for low proportions of research budgets compared with funding levels for research on other major health problems, whereas the expected return on investment is potentially high.
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Multiple sclerosis (MS) is a chronic disease that causes disability due to inflammation and demyelination in the central nervous system. Pain is a common symptom in patients with MS but is often inadequately treated, leading to decreased functioning and a low quality of life. ⋯ Tricyclic antidepressants, anticonvulsants, and opioids are first-line options for central neuropathic pain, and spasmolytics, muscle relaxants, benzodiazepines, and anticonvulsants are helpful for nociceptive pain. Pain should be regularly assessed and appropriately treated to improve functioning and quality of life for patients with MS.
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There has been concern about a high rate of placebo response and a decline in treatment effect over time in schizophrenia trials as well as the implications of increasing conduct of such trials outside North America. This report explores differences in efficacy data over an 18-year period from randomized placebo-controlled trials submitted in support of new drug applications (NDAs) for the treatment of schizophrenia and differences in results between trials conducted in North America and elsewhere. ⋯ A high and increasing placebo response and a declining treatment effect are of great concern in schizophrenia trials conducted in North America. In this era of global clinical trials, close attention is needed to the design and conduct of these trials.