Maintenance Treatment for Patients With Bipolar I Disorder: Results From a North American Study of Quetiapine in Combination With Lithium or Divalproex (Trial 127)

Suppes, Trisha; Vieta, Eduard; Liu, Sherry; Brecher, Martin; Paulsson, Björn; Investigators, Trial

doi:10.1176/appi.ajp.2008.08020189

Cited by 202 publications

(166 citation statements)

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“…After screening, 226 publications were identified through the combined search strategies, and we identified 21 trials, with a combined total of 5364 participants that fulfilled the inclusion criteria (Bowden et al 2000bCalabrese et al 2000Calabrese et al , 2003Calabrese et al , 2005Greil et al 1997 ;Hartong et al 2003 ;Keck et al 2007 ;Macfadden et al 2009 ;McElroy et al 2008 ;Quiroz et al 2010 ;Suppes et al 2009 ;Tohen et al 2003Tohen et al , 2004Tohen et al , 2005Tohen et al , 2006Vieta et al 2008a, b ;Young et al 2008 ;Zarate & Tohen, 2004). Table 1 shows details of all trials included in the analysis.…”

Section: Resultsmentioning

confidence: 99%

“…We identified : one trial each for aripiprazole (Keck et al 2007), olanzapine+mood stabilizer , oxcarbazepine+lithium (Vieta et al 2008a), perphenazine+mood stabilizer (Zarate & Tohen, 2004), risperidone long-acting injectable monotherapy (Quiroz et al 2010), risperidone long-acting injectable+mood stabilizer (Macfadden et al 2009) and ziprasidone+mood stabilizer ; two trials for carbamazepine (Greil et al 1997 ;Hartong et al 2003) and quetiapine+mood stabilizer (Suppes et al 2009 ;Vieta et al 2008 b) and quetiapine monotherapy Young et al 2008) ; three trials each for divalproex (Bowden et al 2000a, b ;Greil et al 1997 ;Tohen et al 2003), lamotrigine Calabrese et al 2000Calabrese et al , 2003 and olanzapine (Tohen et al 2003(Tohen et al , 2005(Tohen et al , 2006 ; and eight trials for lithium (Bowden et al 2000(Bowden et al b, 2003Calabrese et al 2003Calabrese et al , 2005Greil et al 1997 ;Hartong et al 2003 ;Tohen et al 2005 ;Vieta et al 2008a). BPRS, Brief Psychiatric Rating Scale ; CGI-S, Clinical Global Impression -Severity ; CGI-C, Clinical Global Impression -Change ; CI, confidence interval ; GAF, global assessment of functioning ; HAMD, Hamilton Rating Scale for Depression ; IR, insufficient response ; MADRS, Montgomery-Å sberg Depression Rating Scale ; MRS, Mania Rating Scale ; TEM, treatment-emergent mania ; YMRS, Young Mania Rating Scale.…”

Section: Resultsmentioning

confidence: 99%

“…The length of follow-up was 26 wk in three studies Calabrese et al 2000 ;Zarate & Tohen, 2004), between 47 and 52 wk in eight studies (Bowden et al 2000b ;Macfadden et al 2009 ;McElroy et al 2008 ;Tohen et al 2003Tohen et al , 2005Tohen et al , 2006Vieta et al 2008a ;Young et al 2008), between 72 and 80 wk in four studies Calabrese et al 2003Calabrese et al , 2005Tohen et al 2004) and between 100 and 130 wk in six studies (Greil et al 1997 ;Hartong et al 2003 ;Keck et al 2007 ;Quiroz et al 2010 ;Suppes et al 2009 ;Vieta et al 2008b). Median follow-up among the 21 studies was 52 wk, and mean follow-up was 68 wk.…”

Section: Resultsmentioning

confidence: 99%

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Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder: a meta-analysis of randomized controlled trials

Vieta

Günther²,

Locklear

et al. 2011

Int. J. Neuropsychopharm.

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The purpose of this meta-analysis was to examine the efficacy of maintenance treatments for bipolar disorder. Placebo-controlled or active comparator bipolar maintenance clinical trials of o6 months' duration with at least 15 patients/treatment group were identified using Medline, EMBASE, clinicaltrials.gov, and Cochrane databases (1993 to July 2010). The main outcome measure was relative risk for relapse for patients in remission. Twenty trials (5364 patients) were identified. Overall, lithium and quetiapine were the most studied agents (eight and five trials, respectively). The majority of studies included patients who had previously responded to treatment for an acute episode. All interventions, with the exception of perphenazine+mood stabilizer, showed a relative risk for manic/mixed or depressive relapse below 1.0, although there was variation in the statistical significance of the findings vs. placebo. No monotherapy was associated with a significantly reduced risk for both manic/mixed and depressed relapse. Of the combination treatments, only quetiapine+lithium/divalproex, was associated with a significantly reduced risk vs. comparator (placebo+lithium/valproate) for relapse at both the manic/mixed and depressed poles of bipolar illness. Limitations for the analysis include differences in study durations and definitions of relapse. In conclusion, available maintenance therapies show considerable variation in efficacy. The efficacy of lithium and divalproex has been confirmed, but newer therapies, such as a number of atypical antipsychotics were also shown to be effective in bipolar disorder. Efficacy of all maintenance interventions needs to be balanced against the safety and tolerability profiles of individual agents.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder: a meta-analysis of randomized controlled trials

Vieta

Günther²,

Locklear

et al. 2011

Int. J. Neuropsychopharm.

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“…Additional combination therapies included as first‐ line include quetiapine adjunctive therapy with lithium/divalproex (level 1),378, 379 which has demonstrated efficacy in preventing any mood, manic or depressive episode. Aripiprazole plus lithium/divalproex (level 2)380 should also be considered as a first‐line option.…”

Section: Maintenance Therapy For Bipolar Disordermentioning

confidence: 99%

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

et al. 2018

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The Canadian Network for Mood and Anxiety Treatments (CANMAT) previously published treatment guidelines for bipolar disorder in 2005, along with international commentaries and subsequent updates in 2007, 2009, and 2013. The last two updates were published in collaboration with the International Society for Bipolar Disorders (ISBD). These 2018 CANMAT and ISBD Bipolar Treatment Guidelines represent the significant advances in the field since the last full edition was published in 2005, including updates to diagnosis and management as well as new research into pharmacological and psychological treatments. These advances have been translated into clear and easy to use recommendations for first, second, and third‐ line treatments, with consideration given to levels of evidence for efficacy, clinical support based on experience, and consensus ratings of safety, tolerability, and treatment‐emergent switch risk. New to these guidelines, hierarchical rankings were created for first and second‐ line treatments recommended for acute mania, acute depression, and maintenance treatment in bipolar I disorder. Created by considering the impact of each treatment across all phases of illness, this hierarchy will further assist clinicians in making evidence‐based treatment decisions. Lithium, quetiapine, divalproex, asenapine, aripiprazole, paliperidone, risperidone, and cariprazine alone or in combination are recommended as first‐line treatments for acute mania. First‐line options for bipolar I depression include quetiapine, lurasidone plus lithium or divalproex, lithium, lamotrigine, lurasidone, or adjunctive lamotrigine. While medications that have been shown to be effective for the acute phase should generally be continued for the maintenance phase in bipolar I disorder, there are some exceptions (such as with antidepressants); and available data suggest that lithium, quetiapine, divalproex, lamotrigine, asenapine, and aripiprazole monotherapy or combination treatments should be considered first‐line for those initiating or switching treatment during the maintenance phase. In addition to addressing issues in bipolar I disorder, these guidelines also provide an overview of, and recommendations for, clinical management of bipolar II disorder, as well as advice on specific populations, such as women at various stages of the reproductive cycle, children and adolescents, and older adults. There are also discussions on the impact of specific psychiatric and medical comorbidities such as substance use, anxiety, and metabolic disorders. Finally, an overview of issues related to safety and monitoring is provided. The CANMAT and ISBD groups hope that these guidelines become a valuable tool for practitioners across the globe.

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“…Quetiapine monotherapy17 and adjunctive therapy (with lithium or divalproex)18, 19, 20 demonstrated significant efficacy in preventing recurrence of both manic and depressive episodes in bipolar populations. Limited data suggest that OFC might be effective as a long‐term therapy for prevention of depressive relapse,21, 22 although weight gain and metabolic effects may limit the utility of this treatment.…”

Section: Introductionmentioning

confidence: 99%

Lurasidone in the Long‐term Treatment of Patients With Bipolar Disorder: A 24‐week Open‐label Extension Study

et al. 2016

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BackgroundThe aim of this study was to evaluate the safety and tolerability of 6 months of open‐label, uncontrolled extension treatment with lurasidone in patients with a diagnosis of bipolar depression who completed 6 weeks of acute treatment.MethodsPatients completing 6 weeks of double‐blind placebo‐controlled treatment with either lurasidone monotherapy (one study) or adjunctive therapy with lithium or valproate (two studies), were treated for 6 months with flexible doses of lurasidone, 20–120 mg/day, in an open‐label, uncontrolled extension study (N = 813; monotherapy, 38.9%; adjunctive therapy, 61.1%). Changes in safety parameters were calculated from double‐blind, acute‐phase baseline to month 6 of the extension phase, using a last observation carried forward (LOCF endpoint) analysis.ResultsFive hundred fifty‐nine of 817 (68.4%) patients completed the extension study. In the monotherapy and adjunctive therapy groups, 6.9 and 9.0%, respectively, discontinued due to an adverse event. For the monotherapy and adjunctive therapy groups, respectively, changes from double‐blind baseline to month 6 were +0.8 and +0.9 kg for weight (mean), 0.0 and +2.0 mg/dL for total cholesterol (median), +5.0 and +5.0 mg/dL for triglycerides (median), −1.0 and 0.0 mg/dL for glucose (median); −22.6 and −21.7 for Montgomery‐Asberg Depression Rating Scale (MADRS; mean); whereas change from open‐label baseline to month 6 were +0.85 and +0.88 kg for weight (mean), and −6.9 and −6.5 for MADRS (mean).ConclusionsSix months of treatment with open‐label lurasidone was safe and well tolerated with minimal effect on weight and metabolic parameters; continued improvement in depressive symptoms was observed.

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Maintenance Treatment for Patients With Bipolar I Disorder: Results From a North American Study of Quetiapine in Combination With Lithium or Divalproex (Trial 127)

Abstract: In patients stabilized on quetiapine plus lithium or divalproex, continued treatment was associated with a significant risk reduction in the time to recurrence of any mood event compared with placebo and lithium or divalproex.

Cited by 202 publications

References 38 publications

Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder: a meta-analysis of randomized controlled trials

Effectiveness of psychotropic medications in the maintenance phase of bipolar disorder: a meta-analysis of randomized controlled trials

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

Lurasidone in the Long‐term Treatment of Patients With Bipolar Disorder: A 24‐week Open‐label Extension Study

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