The Journal of clinical psychiatry
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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.
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Randomized Controlled Trial
A randomized pilot study of the efficacy and safety of ABT-089, a novel α4β2 neuronal nicotinic receptor agonist, in adults with attention-deficit/hyperactivity disorder.
ABT-089, an α4β2 neuronal nicotinic receptor partial agonist (generic name pozanicline), has demonstrated efficacy in adults with attention-deficit/hyperactivity disorder (ADHD) at doses of 40 mg once daily and 40 mg twice daily. The purpose of this exploratory pilot study was to obtain initial safety, tolerability, and efficacy data for an ABT-089 80-mg once-daily regimen to inform a decision of whether to include an 80-mg once-daily dose regimen in subsequent, definitive (phase 3) efficacy studies. ⋯ ABT-089 was generally well tolerated at doses up to 80 mg. Because ABT-089 is a weak partial neuronal nicotinic receptor agonist, the results may not predict the potential efficacy for other, more potent neuronal nicotinic receptor agonists.
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Posttraumatic stress disorder (PTSD) is a debilitating stress-related illness associated with trauma exposure. The peripheral and central mechanisms mediating stress response in PTSD are incompletely understood. Recent data suggest that the renin-angiotensin pathway, essential to cardiovascular regulation, is also involved in mediating stress and anxiety. In this study, the authors examined the relationship between active treatment with blood pressure medication, including angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), and PTSD symptom severity within a highly traumatized civilian medical population. ⋯ These data provide the first clinical evidence supporting a role for the renin-angiotensin system in the regulation of stress response in patients diagnosed with PTSD. Further studies should examine whether available medications targeting this pathway should be considered for future treatment and potential protection against PTSD symptoms.
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To investigate the association between substance use disorders (SUDs) and the clinical presentation, risk factors, and correlates of major depressive disorder (MDD) by examining differences among 3 groups: (1) individuals with lifetime MDD and no comorbid SUD (MDD-NSUD); (2) individuals with comorbid MDD and SUD (MDD-SUD); and (3) individuals with substance-induced depressive disorder (SIDD). ⋯ MDD-SUD is associated with high overall vulnerability to additional psychopathology, a higher number of and more severe depressive episodes, and higher rates of suicide attempts in comparison to individuals with MDD-NSUD. SIDD has low prevalence in the general population but is associated with increased clinical severity and low rates of medication treatment. Similar patterns of comorbidity and risk factors in individuals with SIDD and those with MDD-SUD suggest that the 2 conditions may share underlying etiologic factors.