The Journal of clinical psychiatry
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Comparative Study
Moral or religious objections to suicide may protect against suicidal behavior in bipolar disorder.
Patients with bipolar disorder are prone to suicidal behavior, yet possible protective mechanisms are rarely studied. We investigated a possible protective role for moral or religious objections to suicide against suicidal ideation and attempts in depressed bipolar patients. ⋯ Higher score on the moral or religious objections to suicide subscale of the RFLI is associated with fewer suicidal acts in depressed bipolar patients. The strength of this association was comparable to that of aggression scores and suicidal behavior, and had an independent effect. A possible protective role of moral or religious objections to suicide deserves consideration in the assessment and treatment of suicidality in bipolar disorder.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of loxapine for inhalation in the treatment of agitation in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial.
The objective of this study was to assess the efficacy and safety of inhaled loxapine in the treatment of agitation in patients with psychotic disorders. ⋯ Inhaled loxapine was generally safe and well tolerated and produced rapid improvement in agitated patients with psychotic disorders. Statistically significant differences in efficacy were found for the 10-mg dose compared with placebo, with results suggesting 5 mg may be effective. The delivery of loxapine by inhalation may provide a rapid, well-tolerated option for treating acute psychotic agitation that allows patients to avoid the aversive effects and loss of autonomy often associated with use of intramuscular medications. Further investigation of this new loxapine formulation is warranted.
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Randomized Controlled Trial Comparative Study
Effect of antidepressant medication treatment on suicidal ideation and behavior in a randomized trial: an exploratory report from the Combining Medications to Enhance Depression Outcomes Study.
To explore relationships between baseline sociodemographic and clinical features and baseline suicidal ideation, and treatment effects on suicidal ideation and behavior, in depressed outpatients. ⋯ Baseline ideation did not affect depressive symptom outcome. Bupropion-SR plus escitalopram most effectively reduced ideation. Ideation emergence was uncommon. Venlafaxine-XR plus mirtazapine may pose a higher risk of suicide attempts.
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Comparative Study Clinical Trial
Effectiveness and safety of vagus nerve stimulation for severe treatment-resistant major depression in clinical practice after FDA approval: outcomes at 1 year.
To describe the outcomes of a consecutive series of depressed patients treated with vagus nerve stimulation (VNS) following US Food and Drug Administration (FDA) approval of this intervention. ⋯ We found that a substantial minority of patients with extremely difficult-to-treat depressive disorders benefited from VNS in an ambulatory clinical practice, with outcomes comparable to those observed in previous VNS efficacy studies and with a similar side effect profile.
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Comparative Study
Comparative effectiveness clinical trials in psychiatry: superiority, noninferiority, and the role of active comparators.
The Agency for Healthcare Research and Quality, part of the US Department of Health and Human Services, has issued several Requests for Applications to conduct comparative effectiveness research (CER). Many of the applications will involve randomized controlled clinical trials that include an active comparator. The inclusion of an active comparator has implications for clinical trial design. Despite a common misperception, a clinical trial result of no significant difference between active treatment groups does not imply equivalence or noninferiority. A noninferiority trial, on the other hand, can directly test whether one active treatment group is noninferior to the other. For example, noninferiority of an inexpensive generic could be tested in comparison with a novel, more costly intervention. Although seldom used in psychiatry, noninferiority clinical trials could play a fundamental role in CER. Features of noninferiority and the nearly ubiquitous superiority designs are contrasted. The noninferiority margin is defined and its application and interpretation are discussed. ⋯ Evidence of noninferiority can only come from well-designed and conducted noninferiority CER. Sample sizes needed in noninferiority trials and in superiority trials that include an active comparator are substantially larger than those needed in trials that can utilize a placebo control in their scientific design. As a result, trials with active comparators are more costly, require longer recruitment duration, and expose more participants to the risks of an experiment than do trials in which the only comparator is placebo.