scholarly journals Mood stabilisers plus risperidone or placebo in the treatment of acute mania

2003 ◽  
Vol 182 (2) ◽  
pp. 141-147 ◽  
Author(s):  
Laksami N. Yatham ◽  
Fred Grossman ◽  
Ilse Augustyns ◽  
Eduard Vieta ◽  
Arun Ravindran
Keyword(s):  
Placebo Group ◽  
Rating Scale ◽  
Plasma Concentrations ◽  
Acute Mania ◽  
Mood Stabiliser ◽  
Young Mania ◽  
Double Blind ◽  
Active Moiety ◽  
Post Hoc ◽  
Risperidone Group

BackgroundFew double-blind trials have examined the efficacy of a combination of a mood stabiliser and an atypical antipsychotic in acute mania.AimsTo determine the efficacy of risperidone in combination with a mood stabiliser in acute mania.MethodPatients taking a mood stabiliser were randomised to 3 weeks' treatment with risperidone (n=75) or placebo (n=76).ResultsYoung Mania Rating Scale (YMRS) scores improved rapidly with significantly greater reductions at week 1 in the risperidone group compared with the placebo group. At end-point YMRS scores decreased by 14.5 and 10.3 points in the risperidone and placebo groups, respectively. Significant improvements v. placebo (P < 0.05) were noted in the risperidone group on several other clinically meaningful measures. Additionally, a post hoc analysis excluding carbamazepine-treated patients (plasma concentrations of risperidone active moiety were 40% lower in this group) revealed significantly greater reductions (P=0.047) in YMRS scores in the risperidone group than in the placebo group. Incidence of adverse events was similar in both groups.ConclusionsRisperidone is superior to placebo when used in combination with lithium or divalproex in acute mania.

scholarly journals Comparison of Adjunctive Quetiapine Versus Adjunctive Haloperidol in Combination with Sodium Valproate for Treatment of Patients with Mania or Mixed Feature Bipolar I Disorder: A Randomized Double-Blind Clinical Trial Study

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Mercedeh Samiei ◽  
Zahra Sepehrifar ◽  
Reza Daneshmand ◽  
Gita Sadighi
Keyword(s):  
Sodium Valproate ◽  
Rating Scale ◽  
Maximum Level ◽  
Acute Mania ◽  
Therapeutic Effects ◽  
Young Mania ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Bipolar I Disorder ◽  
Significant Difference

Background: Acute mania causes many problems for the patient and others. Therefore, it is very important to eliminate the symptoms quickly. Objectives: The present study made the individual comparison of the therapeutic effects of sodium valproate combined with quetiapine or haloperidol as an add-on among patients with bipolar I disorder experiencing an episode of mania or mixed feature admitted to a Psychiatric Center in Tehran. Methods: The present study was a double-blind clinical randomized trial conducted on 36 patients. All patients were investigated by the Young Mania Rating Scale (YMRS). The study lasted six weeks in total (after raising drug dosage to the maximum level). We prescribed sodium valproate 15 mg/kg plus quetiapine 500 mg daily in one group and sodium valproate 15 mg/kg plus haloperidol 10 mg daily in the other group. In addition, an equivalent dosage of quetiapine and haloperidol was prescribed. This study used different data analysis methods such as Paired t test, ANOVA, and chi-square test. Results: The YMRS scores did not show any statistically significant difference between quetiapine and haloperidol receiving groups (P > 0.05). Conclusions: This paper argued that a combination of sodium valproate with either quetiapine or haloperidol could be effective in the management of acute mania or mixed bipolar I disorder to reduce the severity and duration of symptoms, although there was no statistically significant difference between the efficacy of these two pharmacological therapies.

scholarly journals Risperidone in the treatment of acute mania

2005 ◽  
Vol 187 (3) ◽  
pp. 229-234 ◽  
Author(s):  
Sumant Khanna ◽  
Eduard Vieta ◽  
Benjamin Lyons ◽  
Fred Grossman ◽  
Mariëlle Eerdekens ◽  
...  
Keyword(s):  
Rating Scale ◽  
Acute Mania ◽  
Young Mania ◽  
Double Blind ◽  
Manic Symptoms ◽  
End Point ◽  
Increased Risk ◽  
Rapid Control ◽  
Life Threatening ◽  
Point Total

BackgroundSevere mania is life-threatening, carries an increased risk of suicide and has a serious impact on patients and their families. Efficient and rapid control of episodes of acute mania is needed.AimsTo evaluate the safety and efficacy of risperidone monotherapy for acute mania.MethodIn a 3-week, randomised, double-blind trial, 290 in-patients with bipolar l disorder with current manic or mixed episode and a baseline Young Mania Rating Scale (YMRS) score of 20 or more received flexible doses of risperidone (1–6 mg per day) or placebo.ResultsRisperidone was received by 146 patients and placebo by 144. Their mean baselineYMRS score was 37. 2 (s. e. =0. 5). Significantly greater improvements were observed with risperidone than with placebo at weeks l and 2 and at end-point (total YMRS: P<0. 01). Extrapyramidal symptoms were the most frequently reported adverse events in the risperidone group.ConclusionsIn patients with severe manic symptoms, risperidone produced significant improvements in YMRS scores as early as week 1 and substantial changes at end-point. Treatment was well tolerated.

scholarly journals Cariprazine efficacy in bipolar I depression with and without concurrent manic symptoms: post hoc analysis of 3 randomized, placebo-controlled studies

CNS Spectrums ◽  
2019 ◽  
Vol 25 (4) ◽  
pp. 502-510 ◽  
Author(s):  
Roger S. McIntyre ◽  
Trisha Suppes ◽  
Willie Earley ◽  
Mehul Patel ◽  
Stephen M. Stahl
Keyword(s):  
Least Squares ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Simultaneous Occurrence ◽  
Madrs Total Score ◽  
Young Mania ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Manic Symptoms ◽  
Post Hoc

AbstractObjective.Mixed presentations, defined by simultaneous occurrence of depressive and manic symptoms, are difficult to treat. Antidepressants, although commonly used, have weak evidence of efficacy and may increase risk of mood destabilization. The aim of this pooled post hoc analysis was to evaluate the efficacy of cariprazine in the treatment of bipolar depression with or without concurrent manic symptoms.Methods.Patients from 3 randomized, double-blind, placebo-controlled studies who met DSM-IV-TR or DSM-5 criteria for bipolar I disorder with a current major depressive episode were identified to have concurrent manic symptoms by baseline Young Mania Rating Scale total score ≥4. Efficacy was assessed in cariprazine 1.5 and 3 mg/day dose groups versus placebo; analyses included the least squares mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.Results.Of 1383 patients randomized to treatment, 808 (58.4%) had concurrent manic symptoms. For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of −2.5 (p = .0033) and −2.9 (p = .0010), respectively; for patients without manic symptoms, the LSMD was significant for 1.5 mg/day (−3.3; p = .0008), but not for 3 mg/day (−1.9; p = .0562).Conclusion.The results of this post hoc analysis suggest that cariprazine may be an appropriate treatment option for patients with bipolar I depression with or without manic symptoms, with higher doses potentially more effective in patients with manic symptoms.

scholarly journals Celecoxib added to mood stabilizer for treating acute mania in bipolar disorder: A randomized, double -blind, placebo-controlled trial in IRAN

2021 ◽  
Author(s):  
Farhad Faridhosseini ◽  
Ali Talaei ◽  
Najmeh Shahini ◽  
Mahbobeh Eslamzadeh ◽  
Samira Ahrari ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Acute Mania ◽  
Control Group ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Valproate Sodium ◽  
Significant Difference

Abstract Background: Inflammatory processes in the brain contribute to the aetiopathogenesis of acute mania. Cyclooxygenase-2 (COX-2) inhibitors, such as Celecoxib, reduce the production of pro-inflammatory cytokines. The purpose of the present investigation was to assess the efficacy of Celecoxib in the treatment of acute mania.Methods: We conducted a double-blind, placebo-controlled trial at the Specialty in-patient Clinic of Ibn-e-Sina Hospital [Mashhad University of Medical Sciences, Iran] from March 2017 to August 2017. The study involved 58 patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for acute mania screening to participate in the trial were used for the study. Twenty-three patients were assigned to a study group and were given Valproate Sodium 200 mg /BD plus Celecoxib 400 mg/day (200 mg BID). The control group included 22 patients who were given Valproate Sodium 200 mg /BD plus placebo. Patients were assessed by Young Mania Rating Scale (YMRS) at baseline 0, after 9, 18, and 28 days after the medication started. Data were analyzed by using Statistical Package for Social Sciences (SPSS) 11.5., two-way repeated measures analysis of variance, Fisher’s exact test, and T-Test. P≤0.05 was considered to be statistically significant.Results: A total of 58 patients were screened and 45 were randomized. Most of participations in celecoxib group were male (55%) and in placebo group were female (75%). There were no statistically significant differences between the groups regarding number of episode. sex, marital status, past medical history, past psychiatry history and family history P value ≥0.05. A significant difference was observed in the change of scores on Young Mania Rating Scale (YMRS) at week 4 as compared to the baseline in patient groups P: 0.04.Conclusion: This study suggested that Celecoxib can be an effective adjuvant agent in managing patients with acute mania and anti-inflammatory therapies should further be investigated in these patients.Trial registration: Iran clinical trial register: IRCT20200306046708N1

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

2009 ◽  
Vol 194 (1) ◽  
pp. 40-48 ◽  
Author(s):  
Allan H. Young ◽  
Dan A. Oren ◽  
Adam Lowy ◽  
Robert D. McQuade ◽  
Ronald N. Marcus ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rating Scale ◽  
Trial Registration ◽  
Acute Mania ◽  
Controlled Study ◽  
Young Mania ◽  
Double Blind ◽  
Bipolar I Disorder ◽  
Scale Total Score ◽  
Bipolar Mania

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.

scholarly journals Lovastatin as an Adjuvant to Lithium for Treating Manic Phase of Bipolar Disorder: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Ahmad Ghanizadeh ◽  
Motahhar OmraniSigaroodi ◽  
Ali Javadpour ◽  
Mohammad Hossein Dabbaghmanesh ◽  
Sara Shafiee
Keyword(s):  
Clinical Trial ◽  
Bipolar Disorder ◽  
Placebo Group ◽  
Adverse Effects ◽  
Rating Scale ◽  
Clinical Symptoms ◽  
Controlled Clinical Trial ◽  
Young Mania ◽  
Double Blind ◽  
Significant Difference

Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania.Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked.Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1) at baseline to 12.9 (8.7) and 4.1 (5.4) at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2) at baseline to 12.8 (8.07) and 5.8 (4.6) at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects.Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18).

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

The Mania Pathway Protocol: An Application of Evidence-Based Interventions for the Treatment of Acute Mania on an Inpatient Psychiatric Unit

2020 ◽  
pp. 107839032091654
Author(s):  
Avishay A. Adri
Keyword(s):  
Chart Review ◽  
Rating Scale ◽  
Retrospective Chart Review ◽  
Acute Mania ◽  
Evidence Based ◽  
Psychiatric Unit ◽  
Young Mania ◽  
Improvement Project ◽  
Mood Stabilization ◽  
Inpatient Psychiatric Unit

INTRODUCTION: Acute manic episodes are a psychiatric emergency related to violence and poor patient outcomes. Combination psychotropic therapy utilizing a mood stabilizer and an atypical antipsychotic has been shown to be more efficacious for treating acute mania compared to monotherapy with either mood stabilizers or antipsychotics alone. This quality improvement project implemented evidence-based interventions for treating acute mania. The mania pathway protocol was created as a comprehensive clinical guide for guiding mania treatment. The protocol was implemented on an inpatient psychiatric unit for patients with mania diagnoses including manic/mixed episodes of bipolar disorder or schizoaffective disorder. AIMS: (1) to improve the treatment of mania by using evidence-based interventions for rapid mood stabilization and (2) to educate psychiatric providers on up-to-date interventions for treating acute manic states. METHOD: Psychiatric providers were evaluated for knowledge enhancement through a pre-/post–educational session quiz. A retrospective chart review was used for data collection for patients treated with the mania pathway protocol. The retrospective chart review spanned 8 weeks post project implementation. Young Mania Rating Scale (YMRS) scores were analyzed to measure the effect on mania severity. RESULTS: The percentage decrease in mean Young Mania Rating Scale scores from admission to the fifth day of hospitalization was 61%. All psychiatric providers proved knowledge attainment by scoring 100% on the postintervention quiz. CONCLUSIONS: Rapid mood stabilization may be achieved by using a combination therapy–based mania protocol. Educational sessions can enhance psychiatric provider knowledge with regard to evidence-based treatments for mania.

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (6) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

scholarly journals Efficacy of ethyl-eicosapentaenoic acid in bipolar depression: Randomised double-blind placebo-controlled study

2006 ◽  
Vol 188 (1) ◽  
pp. 46-50 ◽  
Author(s):  
Sophia Frangou ◽  
Michael Lewis ◽  
Paul McCrone
Keyword(s):  
Eicosapentaenoic Acid ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Unipolar Depression ◽  
Adjunctive Treatment ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Double Blind Study ◽  
Young Mania ◽  
Double Blind

BackgroundEpidemiological and clinical studies suggest that increased intake of eicosapentaenoic acid (EPA) alleviates unipolar depression.AimsTo examine the efficacy of EPA in treating depression in bipolar disorder.MethodIn a 12-week, double-blind study individuals with bipolar depression were randomly assigned to adjunctive treatment with placebo (n=26) or with 1g/day (n=24) or 2 g/day (n=25) of ethyl-EPA. Primary efficacy was assessed by the Hamilton Rating Scale for Depression (HRSD), with changes in the Young Mania Rating Scale and Clinical Global Impression Scale (CGI) as secondary outcome measures.ResultsThere was no apparent benefit of 2g over 1g ethyl-EPA daily. Significant improvement was noted with ethyl-EPA treatment compared with placebo in the HRSD (P=0.04) and the CGI (P=0.004) scores. Both doses were well tolerated.ConclusionsAdjunctive ethyl-EPA is an effective and well-tolerated intervention in bipolar depression.

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