Olanzapine as Maintenance Therapy in Patients with Bipolar I Disorder

2006 ◽  
Vol 2 (1) ◽  
pp. 225-238
Author(s):  
Mauricio Tohen ◽  
Daniel Yen Lin

ABSTRACTEffective treatments for the prevention of relapse and recurrence of mood episodes in patients with bipolar disorder are essential to reduce the high mortality associated with this condition, and to improve long-term outcomes. While lithium is considered to be effective as a first line maintenance treatment, additional treatment options would provide clinicians with tools to address the needs of individual patients. The efficacy of olanzapine, an atypical antipsychotic, for the prevention of relapse in bipolar disorder has been demonstrated in several randomized controlled double-blind clinical trials, both as monotherapy and in combination with other agents. The data reviewed herein suggest a more robust efficacy of treatment with olanzapine in the prevention of relapse into manic episodes than into depressive episodes. The adverse events observed most frequently in patients treated with olanzapine relative to comparators were related to somnolence (somnolence, fatigue, or hypersomnia) and weight gain (weight gain, or increased appetite). Moreover, a larger proportion of olanzapine-treated patients than comparator-treated patients experienced clinically important weight gain.

2009 ◽  
Vol 1 ◽  
pp. CMT.S1136
Author(s):  
Mark Taylor ◽  
Kirsty Mackay ◽  
Polash Shajahan

Bipolar disorder is a common and serious illness usually requiring long term medication. We critically review the available evidence surrounding the increasing use of quetiapine, a second generation antipsychotic, in both the acute and maintenance phases of bipolar disorder. Large scale, randomized controlled data supports the use of quetiapine in both acute mania and acute bipolar depression, as a safe and effective treatment and probably best used in combination with a traditional ‘mood stabiliser’ such as lithium or divalproex. Also, quetiapine monotherapy has been shown to be effective in bipolar depression. Two recently published studies also confirm that quetiapine in combination with either lithium or divalproex ‘adds value’ to the maintenance treatment of bipolar disorder in terms of delaying relapse compared to either lithium or divalproex alone. Quetiapine is generally well tolerated, although further work on long term weight gain and emergent diabetes would be helpful.


1995 ◽  
Vol 9 (2_suppl) ◽  
pp. 179-184 ◽  
Author(s):  
Stuart Montgomery

Sertraline is a highly selective serotonin re-uptake inhibitor (SSRI) whose efficacy in depression has been established in a number of large placebo-controlled studies in patients with moderate to severe major depressive episodes (DSM-III). This antidepressant efficacy appears to be significantly more effective than placebo and imipramine and at least of the same order as that of the reference tricyclic antidepressants (TCAs) amitriptyline, clomipramine and dothiepin. More recently, two double-blind parallel group studies have demonstrated comparable efficacy to another SSRI, fluoxetine. Sertraline has demonstrated efficacy in the long-term maintenance and prophylaxis of depression and is one of the few SSRIs currently indicated for the prevention of relapse and recurrence of depression. Fixed dose studies have confirmed the efficacy and optimal tolerability of the minimum 50 mg dose. The efficacy of sertraline, demonstrated across a broad spectrum of depression, and its consistently improved tolerability and safety profile over the TCAs, confirm its potential as a first-line treatment for acute and recurrent episodes of depression.


2011 ◽  
Vol 26 (S2) ◽  
pp. 1998-1998
Author(s):  
E. Vieta

Bipolar disorder is difficult to treat. There are several options to treat acute mania, but combination of two or more drugs is the rule rather than the exception, indicating the limitations of currently available therapies. The evidence base for the treatment of bipolar depression is much weaker, and again combination is the rule. Although patients with bipolar disorder may experience resolution of symptoms with acute treatment, many will continue to experience impaired functioning due to the episodic, chronic, and progressive nature of the illness. Maintenance therapy is needed for a variety of reasons, including prevention of relapse, reduction of subthreshold symptoms, decreasing the risk of suicide, and reducing the frequency of rapid cycling and mood instability. Although long-term therapy is usually required to maintain or improve functioning and quality of life, it has been a significant challenge to identify clinically effective treatments for long-term management. There are few currently-available, well-tolerated treatment options that are effective in all phases of bipolar disorder and which prevent recurrence of manic and/or depressive episodes. Questions concerning when to discontinue one of the drugs when two or more are used, or how to switch from one mood stabilizer to another, have not been addressed in clinical trials. Electroconvulsive therapy may be effective in treatment resistant cases and can be used as maintenance when pharmacotherapy is not enough. Psychoeducation may help to enhance treatment adherence and healthy lifestyle. A rational combination of the above mentioned strategies may help to optimize the outcome of this challenging condition.


Author(s):  
Suresh Durgam ◽  
Willie Earley ◽  
Rui Li ◽  
Dayong Li ◽  
Kaifeng Lu ◽  
...  

Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97 weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3—9 mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9 mg/d) or placebo for double-blind treatment (up to 72 weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n = 99) or cariprazine (n = 101). Time to relapse was significantly longer in cariprazine — versus placebo-treated patients (P = .0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI] = 0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥ 10% of patients during open-label treatment; there were no cariprazine adverse events ≥ 10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060. Key words: schizophrenia; cariprazine; long-term treatment; relapse prevention; randomized controlled trial; oral antipsychotics


2020 ◽  
Vol 26 (40) ◽  
pp. 5128-5133
Author(s):  
Kate Levenberg ◽  
Wade Edris ◽  
Martha Levine ◽  
Daniel R. George

Epidemiologic studies suggest that the lifetime prevalence of bipolar spectrum disorders ranges from 2.8 to 6.5 percent of the population. To decrease morbidity and mortality associated with disease progression, pharmacologic intervention is indicated for the majority of these patients. While a number of effective treatment regimens exist, many conventional medications have significant side effect profiles that adversely impact patients’ short and long-term well-being. It is thus important to continue advancing and improving therapeutic options available to patients. This paper reviews the limitations of current treatments and examines the chemical compound Linalool, an alcohol found in many plant species, that may serve as an effective mood stabilizer. While relatively little is known about Linalool and bipolar disorder, the compound has been shown to have antiepileptic, anti-inflammatory, anxiolytic, anti-depressive, and neurotrophic effects, with mechanisms that are comparable to current bipolar disorder treatment options.


2020 ◽  
Vol 36 (12) ◽  
pp. 3147-3152
Author(s):  
Helen J. Zhang ◽  
Nicole Silva ◽  
Elena Solli ◽  
Amanda C. Ayala ◽  
Luke Tomycz ◽  
...  

2019 ◽  
Vol 7 (1) ◽  
Author(s):  
Maximilian Pilhatsch ◽  
Thomas J Stamm ◽  
Petra Stahl ◽  
Ute Lewitzka ◽  
Anne Berghöfer ◽  
...  

Abstract Background Symptoms of anxiety co-occur in a variety of disorders including in depressive episodes of bipolar disorder and in patients with thyrotoxicosis. Treatment of refractory bipolar disorder with supraphysiologic doses of levothyroxine (L-T4) has been shown to improve the phenotypic expression of the disorder and is associated with an increase of circulating thyroid hormones. However, it might be associated with somatic and mental adverse effects. Here we report the investigation of the influence of treatment with supraphysiologic doses of L-T4 on symptoms of anxiety in patients with refractory bipolar depression. Methods Post-hoc analysis from a 6-week, multi-center, randomized, double-blind, placebo-controlled study of the effects of supraphysiologic L-T4 treatment on anxiety symptoms in bipolar depression. Anxiety symptoms were measured weekly with the Hamilton anxiety/somatization factor (HASF) score of the Hamilton Depression Rating Scale (HAMD) and the State- and Trait Anxiety Inventory (STAI). Results Treatment of both groups was associated with a significant reduction in anxiety symptoms (p < 0.001) with no statistical difference between groups (LT-4: from 5.9 (SD = 2.0) at baseline to 3.7 (SD = 2.4) at study end; placebo: from 6.1 (SD = 2.4) at baseline to 4.4 (SD = 2.8) at study end; p = 0.717). Severity of anxiety at baseline did not show a statistically significant correlation to the antidepressive effect of treatment with supraphysiologic doses of L-T4 (p = 0.811). Gender did not show an influence on the reduction of anxiety symptoms (females: from 5.6 (SD = 1.7) at baseline to 3.5 (SD = 2.4) at study end; males: from 6.1 (SD = 2.3) at baseline to 4.0 (SD = 2.4) at study end; p = 0.877). Conclusions This study failed to detect a difference in change of anxiety between bipolar depressed patients treated with supraphysiologic doses of L-T4 or placebo. Comorbid anxiety symptoms should not be considered a limitation for the administration of supraphysiologic doses of L-T4 refractory bipolar depressed patients. Trial registration ClinicalTrials, ClinicalTrials.gov identifier: NCT01528839. Registered 2 June 2012—Retrospectively registered, https://clinicaltrials.gov/ct2/show/study/NCT01528839


Author(s):  
James C. Garbutt ◽  
Alexei B. Kampov-Polevoy ◽  
Cort Pedersen ◽  
Melissa Stansbury ◽  
Robyn Jordan ◽  
...  

AbstractIdentification of new medications for alcohol use disorder (AUD) is important for improving treatment options. Baclofen, a GABAB agonist, has been identified as a potential pharmacotherapy for AUD. In a 16-week double-blind, randomized, placebo-controlled trial, we investigated 30 and 90 mg/day of baclofen compared to placebo and examined effects of dose, sex, and level of pretreatment drinking. One hundred and twenty participants with DSM-IV alcohol dependence (age 46.1 (sd = 10.1) years, 51.7% male) were randomized after exclusion for unstable medical/psychiatric illness and/or dependence on drugs other than nicotine. Seventy-three participants completed the trial. A main effect of baclofen was found [%HDD (F(2,112) = 4.16, p = 0.018, d = 0.51 95%CI (0.06–0.95), 13.6 fewer HDD) and %ABST (F(2,112) = 3.68, p = 0.028, d = 0.49 95%CI (0.04–0.93), 12.9 more abstinent days)] and was driven by the 90 mg/day dose. A sex × dose interaction effect was present for both %HDD (F(2,110) = 5.48, p = 0.005) and %ABST (F(2,110) = 3.19, p = 0.045). Men showed a marginally positive effect for 90 mg/day compared to PBO (%HDD t(110) = 1.88, p = 0.063, d = 0.36 95%CI (−0.09–0.80), 15.8 fewer HDD days; %ABST t(110) = 1.68 (p = 0.096, d = 0.32 95%CI (−0.12–0.76), 15.7 more ABST)) with no effect for 30 mg/day. Women showed a positive effect for 30 mg/day (%HDD, t(110) = 3.19, p = 0.002, d = 0.61 95%CI (0.16–1.05), 26.3 fewer HDD days; %ABST t(110) = 2.73, p = 0.007, d = 0.52 95%CI (0.07–0.96), 25.4 more ABST days) with marginal effects for 90 mg/day on %ABST (p = 0.06) with drop-outs/dose reduction from sedative side-effects of 59% in women at 90 mg/day compared to 5% for men. These findings support the hypothesis that baclofen has efficacy in AUD and suggest that dose and sex be further explored as potential moderators of baclofen response and tolerability.


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