Haloperidol, risperidone and quetiapine in the treatment of acute severe manic episode in bipolar disorder: The experience at the mood disorder unit in Milan

IntroductionPatients affected by severe manic episode, often with delusional symptoms, are commonly treated with a combination of mood stabilizers, antipsychotics and other sedatives. The choice of a specific drug, dose and term is still debated.ObjectivesA naturalistic study on a sample of 84 inpatients affected by acute severe mania treated with a combination therapy.AimsTo compare efficacy and tolerability of haloperidol/risperidone/quetiapine in association with lithium and/or valproate.MethodsEighty-four bipolar inpatients affected by a manic episode according to DSM-5 criteria. Drugs administered according to our best practice. Clinical course weekly monitored with Young Mania Rating Scale (YMRS) for 4weeks. Extrapiramidal side effects (EPSE) monitored with Saint Hans Rating Scale (SHRS).ResultsTwenty-five men (29.76%) and 59 women (70.24%); mean age 43.37 ± 13.58 years. Mean YMRS score T0 40.27 ± 9.04. Forty-one patients (48.81%) treated with haloperidol (3.4 mg/die); 16 (19.05%) with risperidone (4.3 mg/die); 27 (32.14%) with quetiapine (438 mg/die). The 3 groups showed no difference regarding clinical characteristics and YMRS basal scores. Chi2 analysis confirmed an higher response rate (50% of reduction of YMRS final score compared to T0) with haloperidol (χ2 = 14.88; P = 0.00). The repeated-measures model analysis showed a significant decrease (P < 0.05) in YMRS scores in haloperidol vs. risperidone vs. quetiapine patients for all time points from second week. No statistical difference for EPSE was found.ConslusionsWe suggest that haloperidol could be advisable in the treatment of severe mania, with rapid efficacy, even with low doses. Occurrence of EPSE was not considerable during the acute treatment. Studies with a larger sample size, randomization, fixed doses, double blind design are needed.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.1390 ◽

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.

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Augmentative transcranial direct current stimulation (tDCS) in poor responder depressed patients: a follow-up study

CNS Spectrums ◽

10.1017/s1092852913000497 ◽

2013 ◽

Vol 19 (4) ◽

pp. 347-354 ◽

Cited By ~ 7

Author(s):

Bernardo Dell'Osso ◽

Cristina Dobrea ◽

Chiara Arici ◽

Beatrice Benatti ◽

Roberta Ferrucci ◽

...

Keyword(s):

Direct Current ◽

Transcranial Direct Current Stimulation ◽

Repeated Measures ◽

Rating Scale ◽

Drop Out ◽

Young Mania ◽

Double Blind ◽

Direct Current Stimulation ◽

Follow Up Study

ObjectivesTranscranial direct current stimulation (tDCS) is a non-invasive neurostimulation technique that has received increasing interest in the area of mood disorders over the last several years. While acute, double-blind, sham-controlled studies have already reported positive findings in terms of efficacy and safety for tDCS, follow-up data are lacking. This need prompted the present follow-up study, which assesses post-acute effects of tDCS (no maintenance stimulation was performed), in the mid-term, in a sample of major depressives.MethodsAfter completing an acute, open trial of tDCS, 23 outpatients with either major depressive disorder or bipolar disorder entered a naturalistic follow-up (T1) with clinical evaluations at one week (T2), 1 month (T3), and 3 months (T4). A quantitative analysis of Hamilton Depression Rating Scale (HAM-D), Montgomery–Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS) total scores, through repeated measures analysis of variance (ANOVA) (T1–T4) and paired t-test for comparing specific time points (T1–T2, T2–T3, and T3–T4), was performed. In addition, a qualitative analysis on the basis of treatment response and remission (HAM-D) was performed.ResultsEven though a progressive reduction of follow-up completers was observed from T2 to T4 (95.6% at T2, 65.2% at T3, and 47.8% at T4), the antidepressant effects of acute tDCS persisted over 3 months in almost half of the sample. Of note, no post-acute side effects emerged during the follow-up observation. The most frequent causes of drop-out from this study included major modifications in therapeutic regimen (30%) and poor adherence to follow-up visits (17%).ConclusionsIn this mid-term, open, follow-up study, tDCS showed mixed results. Further controlled studies are urgently needed to assess its effects beyond the acute phase.

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Efficacy Of Lurasidone In Major Depression With Mixed Features: Pattern Of Improvement In Depressive And Manic Symptoms

European Psychiatry ◽

10.1016/j.eurpsy.2016.01.1525 ◽

2016 ◽

Vol 33 (S1) ◽

pp. S423-S423

Author(s):

A.A. Nierenberg ◽

J. Tsai ◽

Y. Mao ◽

A. Pikalov ◽

T. Suppes ◽

...

Keyword(s):

Rating Scale ◽

Depression Score ◽

Effect Sizes ◽

Young Mania ◽

Double Blind ◽

Manic Symptoms ◽

Depression Subscale ◽

Mixed Features ◽

Competing Interest ◽

Depressive And Manic Symptoms

IntroductionEvidence indicates that manic symptoms, below the threshold for hypomania (mixed features), are common in individuals with major depressive disorder (MDD).Objectives/aimsTo evaluate the effect of lurasidone on specific depressive and manic symptoms, based on Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) items, in patients with MDD with mixed features.MethodsPatients meeting DSM-IV-TR criteria for MDD, who presented with 2–3 protocol-specified manic symptoms, were randomized to 6 weeks of double-blind treatment with lurasidone monotherapy 20–60 mg/d (n = 109) or placebo (n = 100). Change from baseline in the MADRS total, MADRS-6 core depression subscale, individual MADRS items, and total and individual items of the YMRS were analyzed by MMRM, and Cohen's d effect sizes (d) were calculated for week 6 change scores.ResultsLurasidone improved depressive symptoms at week 6 in the MADRS total score (–20.5 vs. –13.0; P < 0.0001; d = 0.8) and MADRS-6 core depression score (–13.0 vs. –8.5; P < 0.0001; d = 0.7). Significant improvement on lurasidone was observed at week 6 on all ten MADRS items (d = 0.36–0.78). Effect sizes for the MADRS-6 core depression subscale items ranged from 0.36 to 0.78 at week 6. Treatment with lurasidone was associated with significantly greater week 6 improvement on the YMRS (–7.0 vs. –4.9; P < 0.0001). Effect sizes for the 5 YMRS items with baseline item severity ≥ 2 ranged from 0.32 to 0.48.ConclusionsIn this study of MDD with mixed features, lurasidone was effective in treating the range of depressive and manic symptoms that patients presented with.Sponsored by Sunovion Pharmaceuticals Inc.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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

10.21203/rs.3.rs-237985/v1 ◽

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

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Effectiveness of aripiprazole v. Haloperidol in acute bipolar mania

The British Journal of Psychiatry ◽

10.1192/bjp.187.3.235 ◽

2005 ◽

Vol 187 (3) ◽

pp. 235-242 ◽

Cited By ~ 122

Author(s):

Eduard Vieta ◽

Michel Bourin ◽

Raymond Sanchez ◽

Ronald Marcus ◽

Elyse Stock ◽

...

Keyword(s):

Primary Outcome ◽

Rating Scale ◽

Outcome Measure ◽

Treatment Options ◽

Manic Episode ◽

Primary Outcome Measure ◽

Young Mania ◽

Double Blind ◽

Number Of Patients ◽

To Receive

BackgroundDespite several treatment options, adherence to therapy is poor in patients with bipolar disorder.AimsA double-blind, controlled comparison of aripiprazole and haloperidol in patients with bipolar I disorder experiencing acute manic or mixed episodes.MethodPatients (n=347) were randomised to receive aripiprazole or haloperidol in this 12-week, multicentre study. The primary outcome measure was the number of patients in response (550% improvement from baseline in Young Mania Rating Scale score) and receiving therapy at week 12.ResultsAt week 12, significantly more patients taking aripiprazole (49. 7%) were in response and receiving therapy compared with those taking haloperidol (28. 4%; P<0. 001). Continuation rates differed markedly between treatments (week 12: aripiprazole, 50. 9%; haloperidol, 29. 1%). Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole (62. 7% v. 24. 0%).ConclusionsAripiprazole showed superior levels of response and tolerability to haloperidol in the treatment of an acute manic episode for up to 12 weeks.

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Effects of acute caffeine withdrawal on habituated male runners

Journal of Applied Physiology ◽

10.1152/jappl.1994.76.3.1043 ◽

1994 ◽

Vol 76 (3) ◽

pp. 1043-1048 ◽

Cited By ~ 9

Author(s):

R. K. Hetzler ◽

N. Warhaftig-Glynn ◽

D. L. Thompson ◽

E. Dowling ◽

A. Weltman

Keyword(s):

Repeated Measures ◽

Lactate Threshold ◽

Substrate Utilization ◽

Caffeine Intake ◽

Loading Dose ◽

Testing Session ◽

O2 Uptake ◽

Double Blind ◽

Caffeine Withdrawal ◽

Double Blind Design

This study investigated the effects of caffeine withdrawal on six trained caffeine-habituated male runners: age 29.8 +/- 5.8 (SD) yr, height 180.4 +/- 5.4 cm, weight 77.3 +/- 6.7 kg, maximal O2 uptake 63.0 +/- 5.4 ml.kg-1.min-1, and daily caffeine intake 674 +/- 128 mg. The subjects received a loading dose (5 mg/kg body wt) of caffeine 48 h before each testing session. They were then given (using a repeated-measures double-blind design) additional doses of caffeine (5 mg/kg body wt) or a placebo 36, 24, 12, and 2 h before testing. They ran at a velocity corresponding to their lactate threshold for 60 min in a caffeine withdrawal or caffeinated condition. Caffeine withdrawal resulted in no significant differences in absolute O2 uptake, O2 uptake relative to maximal O2 uptake, respiratory exchange ratios, or free fatty acid concentrations. Glycerol concentrations were significantly attenuated in the withdrawal condition. No significant differences were revealed in calculated substrate utilization. It was concluded that caffeine withdrawal significantly affects lipolysis but not substrate utilization during prolonged running.

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Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽

10.1017/s1092852900023075 ◽

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.

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Therapeutic effect and tolerability of quetiapine XR in patients with manic episode, bipolar disorder I

European Psychiatry ◽

10.1016/s0924-9338(11)71930-7 ◽

2011 ◽

Vol 26 (S2) ◽

pp. 220-220

Author(s):

M. Ladea ◽

L.S. Grosu ◽

M.C. Sinca ◽

M.C. Sarpe

Keyword(s):

Bipolar Disorder ◽

Aggressive Behavior ◽

Rating Scale ◽

Involuntary Movement ◽

Good Control ◽

Manic Episode ◽

Extrapyramidal Symptoms ◽

Young Mania ◽

Acute Relapse ◽

Quetiapine Xr

IntroductionAgitation and aggressive behavior are common symptoms in patients with an acute relapse of bipolar mania.ObjectivesQuetiapine XR is an effective treatment in agitated patients with an acute relapse of bipolar disorder.AimsThe aim of this study was to assess the efficacy and tolerability of Quetiapine XR in patients with manic episode.MethodsThis naturalistic, observational study evaluated 45 patients diagnosed with manic episode, bipolar disorder I (DSM IV-TR) for a period of 4 weeks, during which the patients received Quetiapine XR, in doses between 800 mg and 1000 mg per day, using a rapid titration scheme.Efficacy of the treatment was measured using Young Mania Rating Scale (YMRS) and Clinical Global Impression Scale (CGI), performed at baseline, and then weekly. The Overt Aggression Scale-Modified (OAS-M) was used daily until day 4 and then once per week. Extrapyramidal symptoms were assessed with Barnes Akathisia Rating Scale and Abnormal Involuntary Movement Scale.ResultsImportant improvement of OAS-M total score was observed from the second day of treatment. After 4 weeks, more than a half of the patients presented a decrease of YMRS score with more than 50%. The CGI score also significantly improved. The treatment was well tolerated, mild to moderated adverse reactions being registered, without extrapyramidal symptoms.ConclusionsThese results confirm that Quetiapine XR is an effective and safe treatment for patients with an acute relapse of bipolar disorder I, the rapid titration scheme of the doses leading to a good control of aggressive behavior.

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

The British Journal of Psychiatry ◽

10.1192/bjp.188.1.46 ◽

2006 ◽

Vol 188 (1) ◽

pp. 46-50 ◽

Cited By ~ 191

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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Treatment with Risperidone vs. Olanzapine in Naturalistic Study of Bipolar Manic Inpatients

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.1905 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S118-S118

Author(s):

I. Ibanez Plans ◽

E. Nieto ◽

S. Biel

Keyword(s):

Length Of Stay ◽

Manic Episode ◽

Mood Stabilizers ◽

Naturalistic Study ◽

Dsm Iv ◽

The Mean ◽

Baseline Characteristics ◽

Competing Interest ◽

Manic Patients ◽

Risperidone Group

IntroductionThere are very few comparative controlled trials of risperidone versus olanzapine in manic patients. No previous naturalistic study has compared the efficacy of these two antipsychotics in the natural environment of manic inpatients.ObjectiveThe aim of this retrospective and naturalistic study was to evaluate the efficacy of acute treatment with risperidone vs. olanzapine in Bipolar I manic inpatients.Methods(1) Patients: the study includes all the inpatients diagnosed with bipolar I manic episode (DSM-IV) who were admitted during the years 2009 to 2014. Patients treated with risperidone and olanzapine concomitantly (n = 6) and patients not treated with risperidone or olanzapine (n = 129) were excluded.The patients finally included (n = 183) were separated in two groups:– treated with risperidone (n = 89);– treated with olanzapine (n = 94).(2) The Student-T test was used to compare, between the groups, the mean of scores in YMRS and CGI-S scales and the mean of length of stay.ResultsBaseline characteristics were similar between the groups. The majority of patients were also treated with mood stabilizers (46% with lithium and 45% with valproate).The mean decrease in CGI-S scores from baseline to the day of discharge was significantly (P < 0.003) higher in the risperidone group (−2.81 vs. −2.36). The length of stay was significantly (P < 0.004) lower in the olanzapine group (mean of 23.03 days vs. mean of 30.3).Conclusions(1) The CGI-S scores in manic patients treated with risperidone decreased more than in patients treated with olanzapine during admission. (2) The length of stay was significantly lower in patients treated with olanzapine.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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