1.Innovations in Clinical Research Design and Conduct in Psychiatry: Shifting to Pragmatic Approaches.
David M MARKS ; J THANASEELAN ; Chi Un PAE
Psychiatry Investigation 2009;6(1):1-6
The classically structured clinical trial does not offer enough flexibility to make use of continuously emerging knowledge that is generated as the trial progresses. In this regard, there are consistent issues impeding effective psychiatric research, including limitations in efficiency, difficulty demonstrating significant differences between treatment arms, poor external validity, and ethical constraints. For example, research in the field of psychiatry shows that it is growing increasingly more challenging to demonstrate superiority of interventions to placebo in part related to the increasing placebo response rates. Various design innovations and other tricks of the trade have surfaced to improve sensitivity towards detecting drug-placebo differences and reduce sources of bias in psychiatric research. Diverse strategies have been developed to address these obstacles and improve the outcomes of clinical research in psychiatry. The current review highlights many of these innovations and describes examples of their practical use, mainly focusing on the study design and conduct perspectives. In the study design issues, adaptive, equipoise stratified, sequential parallel and effectiveness design will be explored. The proper strategies for pragmatic and ethical conduction of clinical trials will be also discussed in-depth.
Arm
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Bias (Epidemiology)
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Pliability
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Research Design
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Testosterone
2.Triple Reuptake Inhibitors: A Premise and Promise.
David M MARKS ; Chi Un PAE ; Ashwin A PATKAR
Psychiatry Investigation 2008;5(3):142-147
On the horizon there is a new class of psychoactive medications which work by inhibiting the neuronal reuptake of serotonin, norepinephrine, and dopamine. There are multiple potential indications for these drugs. Research suggests that they may have a role in treating depressive disorders, and it is plausible they may have potential efficacy in obesity, addiction, and pain syndromes. The current review describes some of the molecules in development presently and explores the research relevant to possible clinical uses for this class of medications.
Depressive Disorder
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Dopamine
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Neurons
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Norepinephrine
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Obesity
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Serotonin
3.Does Pregabalin Have Neuropsychotropic Effects?: A Short Perspective.
David M MARKS ; Ashwin A PATKAR ; Prakash S MASAND ; Chi Un PAE
Psychiatry Investigation 2009;6(2):55-58
Pregabalin is a newly developed synthetic gamma-aminobutyric acid (GABA) that is approved for the treatment of fibromyalgia and several neuropathy. It has been proven to show analgesic, anxiolytic, anticonvulsant and sleep enhancement effects, which could be applicable in the treatment of a variety of psychiatric disorders. There have been consistent reports that unexplained somatic symptoms (i.e., pain) may be a part of psychiatric disorders such as major depressive disorder (MDD) and anxiety disorders. Previous researches have also suggested the possible therapeutic potential of anticonvulsants as augmentation therapy or monotherapy in the treatment of mood disorders and anxiety disorders. Hence this short perspective tries to prompt and facilitate a shifting of researchers' attention to potential neuropsychotropic drug role of pregabalin to treat a wide range of neuropsychiatric disorders.
Anticonvulsants
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Anxiety Disorders
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Depressive Disorder, Major
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Fibromyalgia
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gamma-Aminobutyric Acid
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Mood Disorders
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Pregabalin