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.

Comparison of efficacy between risperidone and aripiprazole in combination with sodium valproate in patients with acute manic or mixed episodes

2017 ◽  
Vol 41 (S1) ◽  
pp. S749-S749
Author(s):  
N. Amanat ◽  
A. Nazeri Astane ◽  
B. Dieji ◽  
O. Rezaie ◽  
A. Biglarian
Keyword(s):  
Weight Gain ◽  
Sodium Valproate ◽  
Rating Scale ◽  
Analysis Of Covariance ◽  
Young Mania ◽  
Double Blind ◽  
Measurement Evaluation ◽  
Significant Difference ◽  
Competing Interest ◽  
Bipolar Patients

Today, despite of the improvement in the psychological therapeutic approach, mania still remains as a challenging problem for health system. The aim of this study is comparison efficacy of risperidone and aripiprazole in combination with sodium valproate in bipolar patients with acute manic or mixed episodes who hospitalized in Razi psychiatric hospital in Tehran. This study was conducted as a double blind randomized clinical trial in two groups of bipolar disorder patients with manic or mixed episodes (18–65 age). Patients randomly set in two groups who received valproate with aripiprazole or risperidone. Clinical response was assessed with young mania rating scale (YMRS) and weight gain at 3 and 6 weeks. Data was analyzed with Chi2 test, paired t-test and analysis of covariance and repeated measurement. Evaluation of treatment response after 3 and 6 weeks (50% reduction in Young's scale) in both groups did not show any significant difference between the two therapeutic combinations. The combination of sodium valproate and risperidone showed higher weight gain in comparison with the combination of valproate and aripiprazole at the end of week 6 (P < 0.001). The mentioned combination in bipolar I disorder with manic or mixed episode has similar therapeutic effect, so that both of them are effective and usable. There was no difference in their efficacy, and both treatments can be used. Due to the less weight gain, the combination of valproate and aripiprazole in patients who prone to weight gain, this approach is recommended as more safe and effective therapy.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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.

P01-226-Line item analysis in paediatric patients with bipolar I disorder treated with aripiprazole

2011 ◽  
Vol 26 (S2) ◽  
pp. 227-227
Author(s):  
J.-Y. Loze ◽  
R. Mankoski ◽  
J. Zhao ◽  
W. Carson ◽  
E. Youngstrom ◽  
...  
Keyword(s):  
Rating Scale ◽  
Speech Rate ◽  
Randomised Trial ◽  
High Energy ◽  
Young Mania ◽  
Double Blind ◽  
General Behaviour ◽  
Mixed Episode ◽  
Bipolar I Disorder ◽  
Paediatric Patients

IntroductionAripiprazole has demonstrated efficacy for the treatment of paediatric patients (10–17 years) with a manic or mixed episode associated with bipolar I disorder in a clinical trial that utilised the Young Mania Rating Scale (YMRS) Total score as the primary outcome measure.Objectives/aimThis analysis evaluated the profile of discrete symptom response using the YMRS and other measures.MethodsPost-hoc analysis of individual items of the YMRS and the parent or subject version of the General Behaviour Inventory (GBI) Mania and Depression scales using data from a 4-week, double-blind, randomised trial that compared aripiprazole (10 or 30 mg/day, n = 197) with placebo (n = 99).ResultsIn total, 296 patients were randomised; 80% completed the study. Significant decreases at Week 4 (p < 0.05) were seen in eight YMRS items: elevated mood, increased motor activity/energy, need for sleep, irritability, speech (rate and amount), language/thought disorder, abnormal thought content and disruptive/aggressive behaviour. For the GBI, effect sizes for parent-reported mania items were medium to large (for example, 0.41 for ‘depressed but high energy’ to 0.78 for ‘rage combined with unusually happy’) but were consistently small on subject self-reported items of mania and depression and, for the overall scale, had the poorest agreement with clinician ratings.ConclusionsAripiprazole demonstrated improvements in some of the more troublesome symptoms of paediatric patients with bipolar I disorder experiencing an acute manic or mixed episode. Of note, irritability and aggression showed large treatment effects on both clinician and parent-reported measures, but less so for subject-reported measures.

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 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.

A Double-Blind, Placebo-controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
J. Houston ◽  
M. Tohen ◽  
E. Degenhardt ◽  
H. Jamal ◽  
L. Liu ◽  
...  
Keyword(s):  
Rating Scale ◽  
Controlled Trial ◽  
Blood Levels ◽  
Young Mania ◽  
Double Blind ◽  
Mixed Episode ◽  
Bipolar I Disorder ◽  
Double Blind Placebo ◽  
Concomitant Medications ◽  
Unique Study

Aims:This unique study of treatment of the mixed state of bipolar I disorder using simultaneous depression and mania response criteria compared divalproex monotherapy versus olanzapine augmentation in a 6-week, randomized, double-blind trial.Methods:Patients (age 18-60 years) with 14-28 days of divalproex monotherapy (blood levels of 75-125 μg/mL) were randomized to augmentation with olanzapine 5-20 mg/day or placebo. Data collected included: Hamilton Depression Rating Scale (HDRS), Young Mania Rating Scale (YMRS), Clinical Global Impression for Bipolar Illness (CGI-BP), hospitalizations, concomitant medications, and adverse events (AEs). Primary co-objectives were comparisons of baseline to endpoint changes in HDRS and YMRS. Secondary objectives included comparisons of times to onset (25% reduction) and response (50% reduction) in both HDRS and YMRS, change in CGI-BP, hospitalizations, and safety.Results:Patients were 59% female, 51% Caucasian, 33% African American, and 14% Hispanic with mean standard deviation (SD) HDRS and YMRS scores of 22.2 (4.5) and 20.9 (4.4). Mean standard error (SE) score changes for the olanzapine (n=100) or placebo (n=101) arms, respectively, were: HDRS, -9.37 (.55) and -7.69 (.54), p=.022; YMRS, -10.15 (.44) and -7.68 (.44), p< .001; and CGI-BP, -1.34 (.11) and -1.06 (.11), p=.056. Times-to-onset (median 7 vs 14 days) and response (median 25 vs 49 days) were significantly shorter for olanzapine augmentation. One olanzapine patient required hospitalization (p=1.0). Treatment-emergent AEs were consistent with previously-published rates.Conclusion:Six-week olanzapine treatment augmentation was associated with greater and earlier reduction of manic and depressive symptoms in mixed episode patients on divalproex treatment.

scholarly journals Two randomized, double-blind, placebo-controlled trials and one open-label, long-term trial of brexpiprazole for the acute treatment of bipolar mania

2021 ◽  
pp. 026988112098510
Author(s):  
Eduard Vieta ◽  
Gary Sachs ◽  
Denise Chang ◽  
Johan Hellsten ◽  
Claudette Brewer ◽  
...  
Keyword(s):  
Rating Scale ◽  
Partial Agonist ◽  
Acute Mania ◽  
Dose Titration ◽  
Open Label ◽  
Double Blind ◽  
Gradual Improvement ◽  
Mixed Features ◽  
Significant Difference ◽  
Flexible Dose

Background: Brexpiprazole is a dopamine/serotonin receptor partial agonist (D2, 5-HT1A) and antagonist (5-HT2A) approved for treatment of schizophrenia and major depressive disorder (adjunct to antidepressants). Aims: This study aimed to investigate brexpiprazole as monotherapy in acute mania (bipolar I disorder) in two short-term (ST) studies (study 080 and study 081) and one open-label (OL) extension (study 083). Methods: ST studies were three-week randomized, double-blind, flexible dose (2–4 mg/day), placebo-controlled studies. The primary endpoint was mean change in Young Mania Rating Scale (YMRS) total score from baseline to day 21. The OL study was a 26-week flexible dose (2–4 mg/day) study for patients completing the ST studies. Results: A total of 164 and 158 (study 080) and 170 and 162 (study 081) inpatients with DSM-5 mania with/without mixed features were randomized to placebo or brexpiprazole, respectively. The primary analyses did not show a statistically significant difference between brexpiprazole and placebo: study 080: least squares mean difference (95% confidence limits): 0.14 (−1.74, 2.03), p = 0.8797; study 081: −1.62 (−3.56, 0.32), p = 0.1011. OL study patients ( n = 381) demonstrated a gradual improvement in YMRS total score. Akathisia was the only adverse event, with an incidence of ⩾5% with brexpiprazole and more than placebo in the ST studies, or ⩾5% in the OL study. Brexpiprazole was more efficacious in patients with impaired or no insight (predominantly EU patients) than in patients with excellent insight (predominantly US patients). Conclusions: Further studies are necessary to address the potential efficacy of brexpiprazole in acute mania, which should ensure that the study sample is severe enough (especially with regard to insight), and that the dose/titration schedule is not too modest.

scholarly journals The effect of adding curcumin to sodium valproate in treatment of patients with bipolar disorder in the acute phase of mania: a clinical trial.

2020 ◽  
Author(s):  
Farzad Akbarzadeh ◽  
Nabahat Niksun ◽  
Fatemeh Behdani ◽  
Amir Hoshang Mohammadpour ◽  
Mahmoudreza Jaafari ◽  
...  
Keyword(s):  
Sodium Valproate ◽  
Control Group ◽  
P Value ◽  
Double Blind Study ◽  
Young Mania ◽  
Double Blind ◽  
Diagnostic And Statistical Manual ◽  
New Therapeutic Approaches ◽  
Significant Difference ◽  
Inflammatory Processes

Abstract Background: Inflammatory processes in the brain play an important role in etiopathogenesis of many psychiatric disorders including, bipolar mood disorder (BMD) as a life-long episodic disease. An inefficient therapeutic intervention especially for resistant cases makes the necessity of doing more precise investigation to find out new therapeutic approaches apparent. This double-blind study aims to investigate the effect of Crucumin as anti-inflammatory herbal based drug in the treatment of BMD. Results: 78 patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for BMD screening to participate in the trial. The participants included 32 patients in the placebo group receiving sodium valproate and crucumin and 38 patients in the control group receiving placebo and sodium valproate. At the beginning of the study and weeks 1, 2, 4 the patients were assessed by a psychiatrist using Young mania score (YMRS). Fifty four patients completed the trial. Mean age in patients group was 36.28±10.73 and in control group was 32.42 ±9.60.Clinical characteristics of the patients, such as age, did not differ between groups P value ≥0.05. Results showed the process of changes were significant different in both group. The results showed that the changes in the resultss of YMRS, MMSE and CGI scores were significant in each group (P value≤0.001), but no significant difference has been detected between the two groups (p≥0.05).Conclusions: this study suggested that crucumin cannot be an effective adjuvant agent in management of patients with BMD under treatment with sodium valproate.

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).

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