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Acute Mania (acute + mania)

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Medical Sciences	100%

Selected Abstracts

Impact of concurrent alcohol misuse on symptom presentation of acute mania at initial evaluation

BIPOLAR DISORDERS, Issue 6 2002
Ihsan M Salloum
Objectives:, The aim of this study was to evaluate the impact of current alcohol misuse on symptom presentation of acute mania. Methods:, The impact of concurrent alcohol misuse on symptom presentation of acute mania was examined by comparing comorbid subjects with acute bipolar mania complicated by current alcohol misuse (n=60) with subjects with acute bipolar mania without current alcohol misuse (n=196). Results:, Age- and gender-controlled analysis revealed that the comorbid group presented with more severe psychopathology, as indicated by higher number of total mood-related symptoms as well as of higher total number of manic symptoms. Specifically, they presented with significantly higher rates of mood lability and impulsivity, and also demonstrated higher rates of violent behavior, and other drug use. Conclusions:, Acute mania complicated by current alcohol misuse is differentiated from acute mania without alcohol misuse by the presence of higher numbers of manic symptoms and increased high risk behavior such as mood lability, impulsivity, violence, and other drug abuse. [source]

Comparison of carbamazepine and lithium in treatment of bipolar disorder: A systematic review of randomized controlled trials,

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 1 2009
Daniela Ceron-Litvoc
Abstract Objectives To review data from randomized controlled trials (RCTs) assessing the comparative efficacy of carbamazepine and lithium in treatment of acute manic and maintenance phase of bipolar disorder (BD). Design RCTs were identified through a search strategy that included: electronic databases, reference cross-checking, hand search of non-indexed publications, and book chapters on the treatment of BD comparing carbamazepine with lithium. Outcomes investigated were antimanic effect, trial withdrawal, relapse, hospitalization, need for rescue medication, and presence of adverse effects. Selection of studies and data analysis were performed independently by authors. Whenever possible, data from trials were combined through meta-analyses. Relative risks (RR) were estimated for dichotomous data. Results In acute mania, carbamazepine was similar to lithium on the following outcomes: trial withdrawal due to adverse effects, number of participants with at least one adverse effect, improvement in the Clinical Global Impression (CGI). In acute mania, carbamazepine was associated with fewer trial withdrawals. In maintenance treatment, carbamazepine was similar to lithium in relapses and hospitalization, but there were fewer trial withdrawals due to adverse effects on lithium. Conclusion This review suggests that carbamazepine might be comparable to lithium in terms of efficacy and safety, and therefore a valuable option in the treatment of both manic and maintenance phases. Copyright © 2008 John Wiley & Sons, Ltd. [source]

Effect of risperidone on plasma catecholamine metabolites and brain-derived neurotrophic factor in patients with bipolar disorders

HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 7 2006
Reiji Yoshimura
Abstract A combination treatment with a mood stabilizer and an antipsychotic drug is often used in as many as 90% of subjects with acute mania. Recently, augmentation therapy with atypical antipsychotics has been investigated in both the acute and long-term treatment of bipolar disorder with or without psychosis. In the present study, the authors investigated the efficacy of risperidone treatment for both acute manic and depressive episodes in bipolar disorder. Eighteen patients (M/F: 8/10, age: 34,±,15,yr) who met the DSM-IV criteria for bipolar I disorder (12 cases of manic episodes, 6 cases of depressive episodes) with risperidone treatment were evaluated regarding their clinical improvement using the Young Mania rating Scale (YMRS) and the Hamilton rating Scale for Depression (Ham-D). Plasma concentrations of HVA and MHPG were analyzed by HPLC-ECD and plasma brain-derived neurotrophic factor (BDNF) levels were detected by sandwich ELISA. The mean scores of the YMRS were 22, 18, 12, 8, and 5 at time points before and 1, 2, 3, and 4 weeks after the risperidone administration, respectively. The mean scores of the Ham-D were 24, 25, 21, 21, and 19 at time points before and 1, 2, 3, and 4 weeks after the risperidone administration, respectively. The plasma levels of HVA and 3-methoxy-4-hydroxyphenylglycol (MHPG) were observed to have decreased 4 weeks after risperidone administration in manic patients. The levels did not change in depressive patients. The plasma levels of BDNF were decreased in depressive patients compared with manic patients or healthy controls. However, the administration of risperidone did not alter plasma BDNF levels. Copyright © 2006 John Wiley & Sons, Ltd. [source]

A randomized, placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder

BIPOLAR DISORDERS, Issue 3 2010
Eduard Vieta
Vieta E, Nuamah IF, Lim P, Yuen EC, Palumbo JM, Hough DW, Berwaerts J. A randomized, placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder. Bipolar Disord 2010: 12: 230,243. © 2010 The Authors. Journal compilation © 2010 John Wiley & Sons A/S. Objectives:, To evaluate the antimanic efficacy and safety of paliperidone extended-release (ER) tablets in patients with bipolar I disorder. Methods:, This study included a 3-week, double-blind, acute treatment phase (paliperidone ER versus placebo, with quetiapine as control), and a 9-week, double-blind, maintenance phase (paliperidone ER versus quetiapine). Patients [n = 493; Young Mania Rating Scale (YMRS) score , 20] were randomized (2:2:1) to flexibly dosed paliperidone ER (3,12 mg/day), quetiapine (400,800 mg/day), or placebo for the acute treatment phase. During the maintenance phase, patients assigned to placebo were switched to paliperidone ER but not included in analysis of efficacy. Results:, Paliperidone ER was superior to placebo at the 3-week endpoint {primary outcome; least-squares mean difference in change from baseline in YMRS scores [95% confidence interval (CI)]: ,5.5 (,7.57; ,3.35); p < 0.001} and noninferior to quetiapine at the 12-week endpoint [least-squares mean difference (95% CI): 1.7 (,0.47; 3.96)]. The median mode dose during the 12-week treatment period was 9 mg for paliperidone ER and 600 mg for quetiapine. The most common (, 10%) treatment-emergent adverse events during the 12-week period were: headache (16%), somnolence (10%), and akathisia (10%) for paliperidone ER; somnolence (21%), sedation and dry mouth (17% each), headache (14%), and dizziness (13%) for quetiapine. Body weight increase , 7% from baseline to 12-week endpoint was 8% with paliperidone ER and 17% with quetiapine. A higher percentage of paliperidone ER (13.9%) versus quetiapine patients (7.5%) ,switched to depression' at the12-week endpoint. Conclusions:, Paliperidone ER (3,12 mg/day) was efficacious and tolerable in the treatment of acute mania. [source]

Asenapine versus olanzapine in acute mania: a double-blind extension study

BIPOLAR DISORDERS, Issue 8 2009
Roger S McIntyre
Objective:, To assess the efficacy and tolerability of asenapine versus olanzapine in the extended treatment of bipolar mania. Methods:, Patients with bipolar I disorder experiencing acute manic or mixed episodes who completed either of two 3-week, double-blind trials with asenapine 5 or 10 mg twice daily, olanzapine 5 to 20 mg once daily, or placebo were eligible for this 9-week, double-blind extension study. Patients receiving active medication in the 3-week trials continued the same regimen; those who had received placebo were blindly switched to asenapine but were assessed for safety outcomes only. The primary efficacy measure was the change from baseline to day 84 on the Young Mania Rating Scale (YMRS) total score in the per-protocol population. Results on the primary efficacy outcome were used to determine the noninferiority of asenapine versus olanzapine. Results:, A total of 504 patients (placebo/asenapine, n = 94; asenapine, n = 181; olanzapine, n = 229) were enrolled in the extension study. At day 84, the mean (SD) change from baseline in YMRS total score was ,24.4 (8.7) for asenapine and ,23.9 (7.9) for olanzapine. Prespecified statistical analysis for noninferiority indicated no significant difference between asenapine and olanzapine. The overall incidence of treatment-emergent adverse events was similar across treatment groups (77% placebo/asenapine, 77% asenapine, 78% olanzapine). Clinically significant weight gain occurred in 10%, 19%, and 31% of the placebo/asenapine, asenapine, and olanzapine groups, respectively. Conclusions:, Asenapine was efficacious, showed noninferiority to olanzapine, and was well tolerated in the extended treatment of patients experiencing manic symptoms associated with bipolar I disorder. [source]

Risperidone for the treatment of acute mania in children and adolescents with bipolar disorder: a randomized, double-blind, placebo-controlled study

BIPOLAR DISORDERS, Issue 7 2009
Magali Haas
Objectives:, To evaluate the efficacy, safety, and tolerability of risperidone monotherapy for the treatment of an acute mixed or manic episode in children and adolescents with bipolar I disorder. Methods:, This randomized, placebo-controlled, double-blind, 3-arm study (N = 169) included children and adolescents (ages 10,17 years) with a DSM-IV diagnosis of bipolar I disorder, experiencing a manic or mixed episode. Study participants were randomized to placebo (n = 58), risperidone 0.5,2.5 mg/day (n = 50), or risperidone 3,6 mg/day (n = 61) for 3 weeks. The primary efficacy measure was change in Young Mania Rating Scale (YMRS) total score from baseline to end point. Safety assessments included adverse event (AE) monitoring and scores on extrapyramidal symptom rating scales. Results:, Improvement in mean YMRS total score was significantly greater in risperidone-treated subjects than in placebo-treated subjects [mean change (SD) ,9.1 (11.0) for placebo; ,18.5 (9.7) for risperidone 0.5,2.5 mg (p < 0.001); ,16.5 (10.3) for risperidone 3,6 mg (p < 0.001)]. The most common risperidone-associated AEs were somnolence, headache, and fatigue. Mean (SD) weight gain was 0.7 (1.9) kg, 1.9 (1.7) kg, and 1.4 (2.4) kg in the placebo, risperidone 0.5,2.5 mg, and risperidone 3,6 mg groups, respectively, during this 3-week study. Conclusions:, At daily doses of 0.5,2.5 mg and 3,6 mg, risperidone was effective and well tolerated in children and adolescents experiencing acute manic or mixed episodes of bipolar I disorder. Results indicate that risperidone 0.5,2.5 mg has a better benefit,risk profile than risperidone 3,6 mg. [source]

Effects of stimulus intensity on the efficacy and safety of twice-weekly, bilateral electroconvulsive therapy (ECT) combined with antipsychotics in acute mania: a randomised controlled trial

BIPOLAR DISORDERS, Issue 2 2009
Titus SP Mohan
Objectives:, To examine differences in speed of improvement and remission in people with mania undergoing bilateral, brief-pulse, twice-weekly electroconvulsive therapy (ECT) at stimulus intensities administered just above and 2.5 times their individually titrated seizure threshold. Methods:, Consecutive, eligible subjects with mania, prescribed ECT, were randomised to receive treatments at stimulus doses either just above or 2.5 times their individually titrated seizure thresholds. Main outcomes were the speed of improvement and remission as measured by the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions,Improvement scale (CGI-I) and cognitive side effects assessed by the Mini-Mental State Exam, the Wechsler Memory Scale, and a scale for autobiographical memory. Results:, A total of 24/26 subjects (92.3%) given threshold ECT and 22/24 subjects (91.7%) given suprathreshold ECT were significantly improved [CGI = 2; odds ratio (OR) = 1.1, 95% confidence interval (CI): 0.1,8.4; p = 1.0] at the end of ECT. A total of 88% of the sample had remitted [YMRS < 10; threshold 23/26 (88.5%) versus suprathreshold 21/24 (87.5%)], with no significant differences between interventions (OR = 1.1, 95% CI: 0.2, 6.0; p = 1.0). The interventions did not differ significantly in the time or number of ECT treatments required for improvement or remission. Both interventions were equally safe. Conclusions:, Bilateral, twice-weekly ECT delivered at stimulus intensities just above individually titrated seizure threshold was as effective and safe as ECT administered at stimulus intensities 2.5 times seizure threshold in rapidly resolving the symptoms of acute mania. [source]

Rapid tryptophan depletion as a treatment for acute mania: a double-blind, pilot-controlled study

BIPOLAR DISORDERS, Issue 8 2007
Julia Applebaum
Objectives:, Rapid reduction of up to 80% in plasma tryptophan level can be accomplished by administering an oral tryptophan-free amino acid solution, which induces hepatic protein synthesis and thereby depletes available plasma tryptophan. Rapid tryptophan depletion (RTD) has been shown to induce transient depressive symptoms in patients with remitted major depression. The effect of RTD in acutely manic patients has not been studied. Methods:, We carried out a double-blind, placebo-controlled pilot study of RTD in acutely manic patients. Patients were randomized to the treatment groups. Sodium valproate treatment was started at a dose of 1000 mg/day and continued throughout the 7-day study. On days 1-7, patients received a daily tryptophan-free amino acid drink or a placebo drink. The tryptophan-free amino acid drink contained a mix of amino acids without tryptophan. The placebo drink contained the additives and constituents of the real mixture to provide identical flavor and texture without the amino acids. Ratings were administered at baseline and then repeated on days 3, 5, and 7. All ratings were carried out by an experienced rater who was blind to the group assignment of patients. Results:, A total of 23 patients entered the study and 17 completed the 7-day treatment protocol. The patients who received the amino acid drink showed greater improvement in mania ratings. The differences in Young Mania Rating Scale (YMRS) and Clinical Global Impression (GCI) scores were significant. However, the intolerance rate was high (23%) and the findings in this pilot study are based only on results from those patients who were able to tolerate the drink. Conclusions:, Rapid tryptophan depletion may have an antimanic effect. [source]

Plasma free polyunsaturated fatty acid levels are associated with symptom severity in acute mania

BIPOLAR DISORDERS, Issue 7 2007
M Elizabeth Sublette
Objectives:, Nutritionally essential polyunsaturated fatty acids (PUFAs) have been implicated as potentially important factors in mood disorders. For instance, n-3 PUFA supplementation is reported to improve outcomes in major depressive disorder and bipolar disorder. However, the role of PUFAs in acute mania has been minimally investigated. We performed a pilot study to compare plasma levels of free (non-esterified) and esterified PUFAs between patients in an acute manic episode and healthy volunteers, and to explore associations between symptom severity and levels of fatty acids and of the arachidonic acid metabolite, prostaglandin E2 (PGE2). Methods:, Patients (n = 10) who were medication-free for at least two weeks and seeking inpatient admission for an acute manic episode were compared with healthy volunteers (n = 10). Symptom severity was assessed at admission and after six weeks of naturalistic treatment. Fasting baseline free and esterified plasma levels of docosahexaneoic acid (DHA, 22:6n-3), eicosapentaenoic acid (EPA, 20:5n-3), arachidonic acid (AA,20:4n-6) and the AA metabolite PGE2 were determined, and PGE2 levels were tested again at six weeks. Results:, No between-group differences were found in levels of individual or total fatty acids, or of PGE2. Among subjects, manic symptom severity correlated negatively with levels of free AA and free EPA, and positively with the free AA:EPA ratio. PGE2 levels did not differ between groups or in subjects pre- and post-treatment. Conclusions:, Our preliminary results suggest that, in susceptible persons, low plasma levels of free EPA compared with AA are related to the severity of mania. [source]

Efficacy of a protein kinase C inhibitor (tamoxifen) in the treatment of acute mania: a pilot study

BIPOLAR DISORDERS, Issue 6 2007
Carlos A Zarate Jr
Objectives:, Considerable preclinical biochemical and behavioral data suggest that protein kinase C inhibition would bring about antimanic effects. Notably, the structurally highly dissimilar antimanic agents lithium and valproate, when administered in therapeutically relevant paradigms, attenuate protein kinase C inhibition function. There is currently only one relatively selective protein kinase C inhibitor that crosses the blood,brain barrier available for human use , tamoxifen. Our group recently conducted a single-blind study with tamoxifen in acute mania and found that it significantly decreased manic symptoms within a short period of time (3,7 days). In this study, we investigated whether antimanic effects can be achieved with a protein kinase C inhibitor in subjects with mania. Methods:, In a double-blind, placebo-controlled study, 16 subjects with bipolar disorder, manic or mixed, with or without psychotic features, were randomly assigned to receive tamoxifen (20,140 mg/day; n = 8) or placebo (n = 8) for three weeks. Primary efficacy was assessed by the Young Mania Rating Scale. Results:, Subjects on tamoxifen showed significant improvement in mania compared to placebo as early as five days, an effect that remained significant throughout the three-week trial. The effect size for the drug difference was very large (d = 1.08, 95% confidence interval 0.45,1.71) after three weeks (p = 0.001). At study endpoint, response rates were 63% for tamoxifen and 13% for placebo (p = 0.12). Conclusions:, Antimanic effects resulted from a protein kinase C inhibitor; onset occurred within five days. Large, controlled studies with selective protein kinase C inhibitors in acute mania are warranted. [source]

Topiramate monotherapy in the management of acute mania: results of four double-blind placebo-controlled trials

BIPOLAR DISORDERS, Issue 1 2006
Stuart F Kushner
Objective:, To evaluate the efficacy and tolerability of topiramate monotherapy in adults with acute manic or mixed episodes of bipolar I disorder. Methods:, In four trials, adults hospitalized with acute mania, a diagnosis of bipolar I disorder, history of ,1 previous manic or mixed episodes, and ,20 Young Mania Rating Scale (YMRS) score were randomized to double-blind treatment with topiramate (target doses: 200, 400, or 600 mg/day) or placebo; two trials included an active comparator (lithium, 1500 mg/day). The core study duration in all trials was 3 weeks; three trials also had 9-week double-blind extensions. The primary efficacy variable was mean change from baseline in YMRS in the core 3-week study. Results:, Changes in YMRS score during 3 weeks were not significantly different for topiramate versus placebo (mean YMRS reductions, ,5.1 to ,8.4). Mean YMRS reductions in lithium-treated groups were significantly greater (p , 0.001 versus placebo and topiramate). A similar pattern was observed after 12 weeks of double-blind treatment in studies with double-blind extensions. Paresthesia, appetite decrease, dry mouth, and weight loss were more frequently associated with topiramate than with placebo. Conclusions:, These studies do not support the efficacy of topiramate as monotherapy in acute mania or mixed episodes in adults with bipolar I disorder. Topiramate was not associated with mood destabilization measured as mania exacerbation or treatment-emergent depression. Lithium was confirmed as an effective therapy in this population. [source]

Dark therapy for mania: a pilot study

BIPOLAR DISORDERS, Issue 1 2005
Barbara Barbini
Background:, Recent findings suggest that extended bed rest and darkness could stabilize mood swings in rapid cycling bipolar patients. Method:, We exposed 16 bipolar inpatients affected by a manic episode to a regimen of 14 h of enforced darkness from 6 p.m. to 8 a.m. each night for three consecutive days [dark therapy (DT)]. Pattern of mood changes were recorded with the Young Mania Rating Scale (YMRS) and compared with a control group of 16 inpatients matched for age, sex, age at onset, number of previous illness episodes and duration of current episode, and were treated with therapy as usual (TAU). Results:, Adding DT to TAU resulted in a significantly faster decrease of YMRS scores when patients were treated within 2 weeks from the onset of the current manic episode. When duration of current episode was longer, DT had no effect. Follow-up confirmed that good responders needed a lower dose of antimanic drugs and were discharged earlier from the hospital. Conclusions:, Chronobiological interventions and control of environmental stimuli can be a useful add-on for the treatment of acute mania in a hospital setting. [source]

Statistical methods for longitudinal research on bipolar disorders

BIPOLAR DISORDERS, Issue 3 2003
John Hennen
Objectives: Outcomes research in bipolar disorders, because of complex clinical variation over-time, offers demanding research design and statistical challenges. Longitudinal studies involving relatively large samples, with outcome measures obtained repeatedly over-time, are required. In this report, statistical methods appropriate for such research are reviewed. Methods: Analytic methods appropriate for repeated measures data include: (i) endpoint analysis; (ii) endpoint analysis with last observation carried forward; (iii) summary statistic methods yielding one summary measure per subject; (iv) random effects and generalized estimating equation (GEE) regression modeling methods; and (v) time-to-event survival analyses. Results: Use and limitations of these several methods are illustrated within a randomly selected (33%) subset of data obtained in two recently completed randomized, double blind studies on acute mania. Outcome measures obtained repeatedly over 3 or 4 weeks of blinded treatment in active drug and placebo sub-groups included change-from-baseline Young Mania Rating Scale (YMRS) scores (continuous measure) and achievement of a clinical response criterion (50% YMRS reduction). Four of the methods reviewed are especially suitable for use with these repeated measures data: (i) the summary statistic method; (ii) random/mixed effects modeling; (iii) GEE regression modeling; and (iv) survival analysis. Conclusions: Outcome studies in bipolar illness ideally should be longitudinal in orientation, obtain outcomes data frequently over extended times, and employ large study samples. Missing data problems can be expected, and data analytic methods must accommodate missingness. [source]

Assessment of treatment response in mania: commentary and new findings

BIPOLAR DISORDERS, Issue 2 2003
Ross J Baldessarini
Background:, Assessment of therapeutic interventions in bipolar disorder is complicated by rapid, complex clinical changes, high placebo-response rates, and varying times to specific levels of clinical recovery that may not be adequately reflected in averaged rating-scale scores particularly in acute mania, calling for improved methods to evaluate treatment responses. Chengappa et al. (1) propose operational criteria for specific outcomes based on rating-scale data from two placebo-controlled trials of olanzapine in mania. Methods:, These trials and other recent research were considered in commenting on the design, conduct, analysis and interpretation of experimental therapeutic trials in mania and to optimize olanzapine versus placebo contrasts by systematically varying end-point criteria for mania (YMRS) and depression (HDRS) ratings. Results:, Olanzapine versus placebo responses were optimally separated at scores of 10 for final paired mania and depression ratings, or 5 for each rating scale considered separately. Conclusions:, Use of empirically determined end-points derived from standard rating scales used in experimental therapeutics research in mood disorders can improve both outcome-assessment and separation of active treatment from placebo responses in acute mania. [source]