Randomized, Placebo-Controlled Trial of Olanzapine as Maintenance Therapy in Patients With Bipolar I Disorder Responding to Acute Treatment With Olanzapine

Tohen, Mauricio; Calabrese, Joseph R.; Sachs, Gary S.; Banov, Michael D.; Detke, Holland C.; Risser, Richard C.; Baker, Robert W.; Chou, James C.-Y.; Bowden, Charles L.

doi:10.1176/appi.ajp.163.2.247

Cited by 275 publications

(175 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%

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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%

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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“…Both typical and atypical antipsychotics block dopaminergic neurotransmission, and these medications are useful for the treatment of bipolar mania. Emerging evidence also suggests that bipolar depression is also responsive to antipsychotics (Calabrese et al, 2005;Tohen et al, 2006). Therefore, this model is relevant to the study of antipsychotic medications, and dopamine itself, in the treatment of bipolar disorder.…”

Section: Discussionmentioning

confidence: 99%

Strain Differences in Lithium Attenuation of d-Amphetamine-Induced Hyperlocomotion: A Mouse Model for the Genetics of Clinical Response to Lithium

Gould

O’Donnell

Picchini

et al. 2006

Neuropsychopharmacol

109

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Lithium attenuation of stimulant-induced hyperlocomotion is a rodent model that may be useful both to understand the mechanism of the therapeutic action of lithium and to develop novel lithium-mimetic compounds. To lay the foundation for future investigations into the neurobiology and genetics of lithium as a therapeutic agent, we studied the effect of lithium on d-amphetamine-induced hyperlocomotion in 12 (3 outbred) mouse strains. In our initial screening, mice received either (1) no drugs, (2) LiCl only, (3) damphetamine only, or (4) d-amphetamine and LiCl. Whereas there was no significant effect of LiCl alone on locomotion in any strain, there was a large degree of strain variation in the effects of LiCl combined with d-amphetamine. LiCl attenuated d-amphetamine-induced hyperlocomotion in C57BL/6J, C57BL/6Tac, Black Swiss, and CBA/J mice, whereas CD-1, FVB/NJ, SWR/J, and NIH Swiss mice, which were responsive to d-amphetamine, showed no significant effect of LiCl. d-Amphetamine-induced hyperlocomotion in the C3H/HeJ strain was increased by pretreatment with lithium. A subset of strains were treated for 4 weeks with lithium carbonate before the damphetamine challenge, and in each of these strains, lithium produced effects identical to those seen following acute administration. Strain responsiveness to lithium was not dependent upon the dose of either d-amphetamine or LiCl. Further, the results are not explained by brain lithium levels, which suggests that these behavioral responses to lithium are under the control of inherent genetic or other biological mechanisms specific to the effects of lithium on brain function.

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“…Although olanzapine (level 1)381, 382 is effective in preventing any mood, manic or depressive episode, it is considered second‐line treatment because of safety issues such as metabolic syndrome. Biweekly long‐acting injectable risperidone monotherapy (level 1)383 or adjunctive therapy (level 2)384 has demonstrated efficacy in preventing any mood or manic episode, but had no clear efficacy in depressive episode prevention in these trials.…”

Section: Maintenance Therapy For Bipolar Disordermentioning

confidence: 99%

“…Likewise, oxcarbazepine adjunctive therapy requires further evaluation (level 4) 394, 395, 396. No recommendation is made for topiramate as there is an absence of controlled data supporting its efficacy in maintenance (level 4 negative), and a lack of efficacy in acute mania381; however, its use may be indicated as it has efficacy for many syndromes that are often comorbid with BD (Section 7).…”

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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Randomized, Placebo-Controlled Trial of Olanzapine as Maintenance Therapy in Patients With Bipolar I Disorder Responding to Acute Treatment With Olanzapine

Abstract: Compared to placebo, olanzapine delays relapse into subsequent mood episodes in bipolar I disorder patients who responded to open-label acute treatment with olanzapine for a manic or mixed episode.

Cited by 275 publications

References 10 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

Strain Differences in Lithium Attenuation of d-Amphetamine-Induced Hyperlocomotion: A Mouse Model for the Genetics of Clinical Response to Lithium

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

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