Risperidone Versus Risperidone Plus Sodium Valproate for Treatment of Bipolar Disorders: A Randomized, Double-Blind Clinical-Trial

Moosavi, Seyed Mohamad; Ahmadi, Mahshid; Monajemi, Mani B.

doi:10.5539/gjhs.v6n6p163

Cited by 9 publications

(8 citation statements)

References 20 publications

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“…After the traditional mood stabilizer yields sufficient therapeutic benefit, risperidone may be tapered in order to lower the risks of weight gain or metabolic side effects that were identified in the primary report of the TEAM study 16 . Although the sample was very small, a recent study in adults showed improvement in bipolar depression happened more quickly with a combination of risperidone and valproic acid verus risperidone alone 26 . Similar to our study, this group found that despite the early improvement, at study end, both groups had the same degree of improvement.…”

Section: Discussionmentioning

confidence: 98%

Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study

Salpekar

Joshi

Axelson

et al. 2015

Journal of the American Academy of Child & Adolescent Psych

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Objective To assess the efficacy of mood-stabilizing medications for depression and suicidality in pediatric bipolar disorder. Method The Treatment of Early Age Mania (TEAM) study is a multicenter, prospective, randomized and masked comparison of divalproex sodium (VAL), lithium carbonate (LI), and risperidone (RISP) in an 8-week parallel clinical trial. 279 children with DSM-IV diagnoses of bipolar I disorder, mixed or manic, aged 6-15 years were enrolled. The primary outcome measure was improvement on the Clinical Global Impression scale for depression (CGI-BP-I-D). Secondary outcome measures included the Children's Depression Rating Scale (CDRS-R) and suicidality status. Statistics included longitudinal analysis of outcomes using generalized linear mixed models with random intercept both for the complete data set and by using last observation carried forward. Results CGI-BP-I-D ratings were better in the RISP group (60.7%) as compared to the LI (42.2%; p = .03) or VAL (35.0%; p=.003) groups from baseline to the end of the study. CDRS scores in all treatment groups improved equally by study end. In week 1, scores were lower with RISP compared to VAL (mean = 4.72, 95%CI: 2.67-6.78), and compared to LI (mean = 3.63, 95%CI: 1.51-5.74), though group differences were not present by the end of the study. Suicidality was infrequent, and there was no overall effect of treatment on suicidality ratings. Conclusion Depressive symptoms, present in the acutely manic or mixed phase of pediatric bipolar disorder, improved with all three medications, though RISP appeared to yield more rapid improvement than LI or VAL and was superior using a global categorical outcome.

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Section: Discussionmentioning

confidence: 98%

Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study

Salpekar

Joshi

Axelson

et al. 2015

Journal of the American Academy of Child & Adolescent Psych

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“…In patients refractory to lithium, valproate, or carbamazepine, it is beneficial to add haloperidol, olanzapine, quetiapine, aripiprazole, or asenapine ( Szegedi et al, 2012 ) ( Sachs et al, 2002 , 2004 ; Tohen et al, 2002b ; Yatham et al, 2007 ; Vieta et al, 2008b ) but not ziprasidone, topiramate, risperidone, or paliperidone ( Roy Chengappa et al, 2006 ; Berwaerts et al, 2011 ; Sachs et al, 2012a , 2012b ; Moosavi et al, 2014 ). One study that used a mixed population with some patients entering after a minimum of 2 weeks of mood stabilizer therapy, and others starting a mood stabilizer and risperidone in parallel, provided inconclusive data for risperidone ( Yatham et al, 2003 ) as the results were likely confounded by the effects of carbamazepine on serum levels of risperidone.…”

Section: Efficacy Datamentioning

confidence: 99%

The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 2: Review, Grading of the Evidence, and a Precise Algorithm

Fountoulakis

Yatham

Grunze

et al. 2016

IJNPPY

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Background:The current paper includes a systematic search of the literature, a detailed presentation of the results, and a grading of treatment options in terms of efficacy and tolerability/safety.Material and Methods:The PRISMA method was used in the literature search with the combination of the words ‘bipolar,’ ‘manic,’ ‘mania,’ ‘manic depression,’ and ‘manic depressive’ with ‘randomized,’ and ‘algorithms’ with ‘mania,’ ‘manic,’ ‘bipolar,’ ‘manic-depressive,’ or ‘manic depression.’ Relevant web pages and review articles were also reviewed.Results:The current report is based on the analysis of 57 guideline papers and 531 published papers related to RCTs, reviews, posthoc, or meta-analysis papers to March 25, 2016. The specific treatment options for acute mania, mixed episodes, acute bipolar depression, maintenance phase, psychotic and mixed features, anxiety, and rapid cycling were evaluated with regards to efficacy. Existing treatment guidelines were also reviewed. Finally, Tables reflecting efficacy and recommendation levels were created that led to the development of a precise algorithm that still has to prove its feasibility in everyday clinical practice.Conclusions:A systematic literature search was conducted on the pharmacological treatment of bipolar disorder to identify all relevant random controlled trials pertaining to all aspects of bipolar disorder and graded the data according to a predetermined method to develop a precise treatment algorithm for management of various phases of bipolar disorder. It is important to note that the some of the recommendations in the treatment algorithm were based on the secondary outcome data from posthoc analyses.

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“…Of the remaining 29 trials, 5 were excluded from the primary 24-week analysis because they were either 12-week trials (n = 3, EXXELERATE, 20 REALISTIC, 21 and Lan 22 ) or were disconnected from the network due to switching or rerandomization prior to the 24-week time point (n = 2, Abe 23 and CNTO 148 24 ). Five additional trials were excluded as either all treatment arms were monotherapy (n = 3, ADACTA, 25 SATORI, 26 and MONARCH 27 ) or because excluding monotherapy arms only left a single treatment arm (n = 2, ACT-RAY 28 , 29 and JESMR 30 ) ( Supplementary Material, Figure S1 ). Furthermore, for the purpose of this analysis, treatment arms investigating monotherapy or treatment doses that were out of scope were excluded from trials with more than two treatment arms (eg, ORAL SCAN 31 and ORAL STANDARD 32 [TOFA 10 mg + MTX]; ORAL STRATEGY 13 [TOFA 5 mg monotherapy]; Edwards 33 [RTX 1000 mg monotherapy]; SERENE 34 [RTX 500 mg + MTX]; and MOBILITY 18 [SARI 150 mg + MTX]).…”

Section: Resultsmentioning

confidence: 99%

A Network Meta-Analysis to Compare Effectiveness of Baricitinib and Other Treatments in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate

Fakhouri

Wang

Torre

et al. 2020

JHEOR

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Background/Objectives: This article compares the effectiveness of baricitinib (BARI) 4 mg (oral, Janus kinase [JAK] 1/2 inhibitor) versus other targeted synthetic/biologic disease-modifying antirheumatic drugs, in combination with methotrexate (MTX), in moderate-to-severe rheumatoid arthritis patients with inadequate response (IR) to MTX. Methods: A systematic literature review was conducted to identify randomized controlled trials (RCTs) of the interventions of interest. Bayesian network meta-analyses (NMA) were used to compare American College of Rheumatology (ACR) responses at 24 weeks. A series of prespecified sensitivity analyses addressed the potential impact of, among others, baseline risk, treatment effect modifiers, and trial design on treatment response. Results: Nineteen RCTs were included in the NMA (primary analysis). For ACR20, BARI 4 mg + MTX was found to be more effective than adalimumab (ADA) 40 mg + MTX (Odds Ratio [OR] 1.33), abatacept (ABA) 10 mg + MTX (IV/4 weeks) (OR 1.45), infliximab (IFX) 3 mg + MTX (IV/8 wks) (OR 1.63), and rituximab (RTX) 1000 mg + MTX (OR 1.63). No differences were found on ACR50. For ACR70, BARI 4 mg + MTX was more effective than ADA 40 mg + MTX (OR 1.37), ABA 10 mg + MTX (OR 1.86), and RTX 1000 mg + MTX (OR 2.26). Sensitivity analysis including 10 additional RCTs with up to 20% of patients with prior biologic use showed BARI 4 mg + MTX to be more effective than tocilizumab (TCZ) 8 mg + MTX on ACR20 (OR 1.44). Results for all sensitivity analyses were consistent with the direction and magnitude of the primary results. Key limitations include the time span in which trials were conducted (1999–2017), during which patient characteristics and treatment approaches might have changed. Conclusion: This NMA suggests that BARI 4 mg + MTX is an efficacious treatment option in the MTX-IR population as evidenced by the robustness of results.

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Risperidone Versus Risperidone Plus Sodium Valproate for Treatment of Bipolar Disorders: A Randomized, Double-Blind Clinical-Trial

Cited by 9 publications

References 20 publications

Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study

Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study

The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 2: Review, Grading of the Evidence, and a Precise Algorithm

A Network Meta-Analysis to Compare Effectiveness of Baricitinib and Other Treatments in Rheumatoid Arthritis Patients with Inadequate Response to Methotrexate

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