Using comparative effectiveness design to improve the generalizability of bipolar treatment trials data: Contrasting LiTMUS baseline data with pre-existing placebo controlled trials

Friedman, Edward S.; Calabrese, Joseph R.; Ketter, T.A.; Leon, Andrew C.; Thase, Michael E.; Bowden, Charles L.; Sylvia, Louisa G.; Ostracher, M. J.; Severe, Joanne B.; Iosifescu, Dan V.; Nierenberg, Andrew A.; Reilly-Harrington, Noreen A.

doi:10.1016/j.jad.2013.05.052

Cited by 6 publications

(3 citation statements)

References 35 publications

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“…Хотя следует заметить, что большинство других ис-следований, проведенных у больных БАР II, в связи со сложностями диагностики и соответственно на-бора пациентов также включали небольшое число участников [15]. Кроме того, эксперты рекомендуют проведение сравнительных исследований препара-тов разных групп в условиях, максимально прибли-женных к повседневной практике, поскольку слиш-ком жесткие критерии включения и исключения больных в плацебо-контролируемых рандомизиро-ванных клинических исследованиях ограничивают экстраполяцию их результатов на реальную популя-цию пациентов [17,18], что мы также пытались учесть при планировании данного исследования.…”

Section: Discussionunclassified

A comparative study of different types of pharmacotherapy in treatment of depressive phase of bipolar II disorder

Ushkalova

Kostyukova

2015

Z. nevrol. psikhiatr. im. S.S. Korsakova

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Section: Discussionunclassified

A comparative study of different types of pharmacotherapy in treatment of depressive phase of bipolar II disorder

Ushkalova

Kostyukova

2015

Z. nevrol. psikhiatr. im. S.S. Korsakova

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“…4 By design, these studies had extensive inclusion and exclusion criteria that limit the generalizability of the results 5,6 ; the patients who participated in the studies represent a small fraction of the patients treated by clinicians. These patients have a limited scope of comorbid psychiatric and medical conditions and limited (if any) risk of suicidal behavior.…”

Section: Challenges For Researchersmentioning

confidence: 99%

Improving the Care of Patients Who Have Treatment-Resistant Depression: The Promise of the PCORnet Mood Network

Nierenberg¹,

Sylvia²,

Doederlein³

et al. 2015

J. Clin. Psychiatry

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“…The data used by Zhou and colleagues 1 arise from carefully controlled efficacy studies that address the question, Does the intervention have an effect on the outcome of interest? 4 By design, these studies had extensive inclusion and exclusion criteria that limit the generalizability of the results 5,6 ; the patients who participated in the studies represent a small fraction of the patients treated by clinicians. These patients have a limited scope of comorbid psychiatric and medical conditions and limited (if any) risk of suicidal behavior.…”

Section: Challenges For Researchersmentioning

confidence: 99%

Improving the Care of Patients Who Have Treatment-Resistant Depression: The Promise of the PCORnet Mood Network

Nierenberg,

Sylvia,

Doederlein

et al. 2015

J. Clin. Psychiatry

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See article by Zhou et al I n this issue of JCP, Zhou and colleagues 1 review and integrate placebo-controlled efficacy trials of medications for treatment-resistant depression (TRD) to compare efficacy in a meta-analysis. They conclude that, among 11 augmentation options for TRD, aripiprazole and quetiapine have the most robust evidence for efficacy, with the caveats that these treatments carry substantial risks of adverse events and no long-term data are available. In the absence of direct comparisons, this exercise highlights the formidable challenges that clinicians face when making decisions. While Zhou and colleagues 1 provide an excellent analysis of the available data, we will argue that these findings are of limited use for most people receiving and providing care for TRD. As stated by Tricoci and colleagues in commenting on guidelines in cardiology, "the current system generating research is inadequate to satisfy the information needs of caregivers and patients in determining benefits and risks of drugs, devices, and procedures. " 2(p837) It is not just in psychiatry that we lack evidence for most clinical decisions. We need a new research paradigm beyond meta-analyses of efficacy studies.

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Using comparative effectiveness design to improve the generalizability of bipolar treatment trials data: Contrasting LiTMUS baseline data with pre-existing placebo controlled trials

Cited by 6 publications

References 35 publications

A comparative study of different types of pharmacotherapy in treatment of depressive phase of bipolar II disorder

A comparative study of different types of pharmacotherapy in treatment of depressive phase of bipolar II disorder

Improving the Care of Patients Who Have Treatment-Resistant Depression: The Promise of the PCORnet Mood Network

Improving the Care of Patients Who Have Treatment-Resistant Depression: The Promise of the PCORnet Mood Network

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