A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Quetiapine or Lithium as Monotherapy for Mania in Bipolar Disorder

Bowden, Charles L.; Grunze, Heinz; Mullen, Jamie; Brecher, Martin; Paulsson, Björn; Jones, Martin; Vågerö, Mårten; Svensson, Kristoffer

doi:10.4088/jcp.v66n0116

Cited by 323 publications

(209 citation statements)

References 36 publications

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“…The findings reported here are similar to results from 12-week studies with other atypical agents -olanzapine, 23 quetiapine 24,25 and risperidone 26 -that have shown maintenance of effect for up to 12 weeks.…”

Section: Discussionsupporting

confidence: 85%

Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study

et al. 2009

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BackgroundWell-tolerated and effective therapies for bipolar mania are required.AimsTo evaluate the efficacy and tolerability of aripiprazole as acute and maintenance of effect therapy in patients with bipolar I disorder experiencing manic or mixed episodes.MethodPatients were randomised to double-blind aripiprazole (15 or 30 mg/day; n=167) placebo (n=153) or haloperidol (5–15 mg/day, n=165) for 3 weeks (trial registration NCT00097266). Aripiprazole- and haloperidol-treated patients remained on masked treatment for 9 additional weeks.ResultsMean change in Young Mania Rating Scale Total score (primary end-point) at week 3 was significantly greater with aripiprazole (–12.0; P<0.05) and haloperidol (–12.8; P<0.01) than with placebo (–9.7). Improvements were maintained to week 12 for aripiprazole (–17.2) and haloperidol (–17.8). Aripiprazole was well tolerated. Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole (53.3% v. 23.5%).ConclusionsClinical improvements with aripiprazole were sustained to week 12. Aripiprazole was generally well tolerated.

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Section: Discussionsupporting

confidence: 85%

Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study

et al. 2009

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“…The potentially harmful side effects of lithium depend on the dose, duration of treatment, and age of the patient at the time of treatment. The doses used in this study are in the same range as those used for adult humans (Bowden et al, 2005). We did not find any difference in the body weights of the vehicle-and lithium-treated rats.…”

Section: Discussionmentioning

confidence: 74%

Lithium-Mediated Long-Term Neuroprotection in Neonatal Rat Hypoxia–Ischemia is Associated with Antiinflammatory Effects and Enhanced Proliferation and Survival of Neural Stem/Progenitor Cells

et al. 2011

J Cereb Blood Flow Metab

103

112

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The aim of this study was to evaluate the long-term effects of lithium treatment on neonatal hypoxicischemic brain injury, inflammation, and neural stem/progenitor cell (NSPC) proliferation and survival. Nine-day-old male rats were subjected to unilateral hypoxia-ischemia (HI) and 2 mmol/kg lithium chloride was injected intraperitoneally immediately after the insult. Additional lithium injections, 1 mmol/kg, were administered at 24-hour intervals for 7 days. Animals were killed 6, 24, 72 hours, or 7 weeks after HI. Lithium reduced total tissue loss by 69%, from 89.4 ± 14.6 mm 3 in controls (n = 15) to 27.6 ± 6.2 mm 3 in lithium-treated animals (n = 14) 7 weeks after HI (P < 0.001). Microglia activation was inhibited by lithium treatment, as judged by Iba-1 and galectin-3 immunostaining, and reduced interleukin-1b and CCL2 levels. Lithium increased progenitor, rather than stem cell, proliferation in both nonischemic and ischemic brains, as judged by 5-bromo-2-deoxyuridine labeling 24 and 72 hours as well as by phospho-histone H3 and brain lipid-binding protein labeling 7 weeks after HI. Lithium treatment also promoted survival of newborn NSPCs, without altering the relative levels of neuronal and astroglial differentiation. In summary, lithium conferred impressive, morphological long-term protection against neonatal HI, at least partly by inhibiting inflammation and promoting NSPC proliferation and survival.

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“…Placeboassociated improvement in mean mania ratings relative to baseline varied greatly, from À19% (Zarate et al, 2007) or + 0.63% (Pope et al, 1991) to + 38% (McIntyre et al, 2009a). Likewise, study drop-out rates ranged from 13-15% (Kushner et al, 2006;Smulevich et al, 2005, respectively) to 82% (Hirschfeld et al, 2010) with placebo, and from 11-14% (Bowden et al, 2005;Khanna et al, 2005;Smulevich et al, 2005) to 83% (Hirschfeld et al, 2010) with drug. The impact of these sources of variance lie beyond this study and are reported separately (Yildiz et al, 2010).…”

Section: Characteristics Of Trials and Subjectsmentioning

confidence: 99%

Efficacy of Antimanic Treatments: Meta-analysis of Randomized, Controlled Trials

Yıldız

Vieta

Leucht

et al. 2010

Neuropsychopharmacol

225

172

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We conducted meta-analyses of findings from randomized, placebo-controlled, short-term trials for acute mania in manic or mixed states of DSM (III-IV) bipolar I disorder in 56 drug-placebo comparisons of 17 agents from 38 studies involving 10 800 patients. Of drugs tested, 13 (76%) were more effective than placebo: aripiprazole, asenapine, carbamazepine, cariprazine, haloperidol, lithium, olanzapine, paliperdone, quetiapine, risperidone, tamoxifen, valproate, and ziprasidone. Their pooled effect size for mania improvement (Hedges' g in 48 trials) was 0.42 (confidence interval (CI): 0.36-0.48); pooled responder risk ratio (46 trials) was 1.52 (CI: 1.42-1.62); responder rate difference (RD) was 17% (drug: 48%, placebo: 31%), yielding an estimated number-needed-to-treat of 6 (all po0.0001). In several direct comparisons, responses to various antipsychotics were somewhat greater or more rapid than lithium, valproate, or carbamazepine; lithium did not differ from valproate, nor did second generation antipsychotics differ from haloperidol. Meta-regression associated higher study site counts, as well as subject number with greater placebo (not drug) response; and higher baseline mania score with greater drug (not placebo) response. Most effective agents had moderate effect-sizes (Hedges' g ¼ 0.26-0.46); limited data indicated large effect sizes (Hedges' g ¼ 0.51-2.32) for: carbamazepine, cariprazine, haloperidol, risperidone, and tamoxifen. The findings support the efficacy of most clinically used antimanic treatments, but encourage more head-to-head studies and development of agents with even greater efficacy.

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A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Quetiapine or Lithium as Monotherapy for Mania in Bipolar Disorder

Cited by 323 publications

References 36 publications

Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study

Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study

Lithium-Mediated Long-Term Neuroprotection in Neonatal Rat Hypoxia–Ischemia is Associated with Antiinflammatory Effects and Enhanced Proliferation and Survival of Neural Stem/Progenitor Cells

Efficacy of Antimanic Treatments: Meta-analysis of Randomized, Controlled Trials

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