Disorders - Bipolar Disorders
Haas, M., Delbello, M. P., Pandina, G., Kushner, S., Van Hove, I., Augustyns, I., Quiroz, J., Kusumakar, V.
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. (copyright) 2009 The
Authors. Journal compilation (copyright) 2009 John Wiley & Sons A/S.
Bipolar
Disorders, 11(7) : 687-700
- Year: 2009
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Atypical Antipsychotics (second
generation)
Grunze, Heinz, Vieta, Eduard, Goodwin, Guy
M., Bowden, Charles, Licht, Rasmus W., Moller, Hans-Jurgen, Kasper, Siegfried
These updated guidelines are based on a
first edition that was published in 2003, and have been edited and updated with the available scientific evidence until end of 2008. Their purpose is
to supply a systematic overview of all scientific evidence pertaining to the treatment of acute mania in adults. The data used for these guidelines
have been extracted from a MEDLINE and EMBASE search, from the clinical trial database clinicaltrials.gov, from recent proceedings of key
conferences, and from various national and international treatment guidelines. Their scientific rigor was categorised into six levels of evidence
(A-F). As these guidelines are intended for clinical use, the scientific evidence was finally asigned different grades of recommendation to ensure
practicability.
World Journal of Biological Psychiatry, 10(2) : 85-116
- Year: 2009
- Problem: Bipolar Disorders
- Type: Systematic reviews
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any)
Hebrani, P., Behdani, F., Manteghi, A. A.
Objective: To study the efficacy and safety of Topiramate versus Sodium Valproate for the Treatment of Bipolar Disorder
in Adolescents Methodology: One hundred twenty adolescents (aged 12-18) with an admission diagnosis of bipolar I disorder, manic or mixed episode
were enrolled from the Adolescent Ward at Ebn-e-Sina Psychiatric Center of Mashhad University. They were assigned to receive 8 weeks of double-
blinded, flexibly dosed treatment with topiramate or sodium valproate. The primary efficacy measure was the mean change from baseline to endpoint in
the Young Mania Rating Scale (YMRS). Results: Sodium Valproate was superior to topiramate. The YMRS scores decreased significantly in both groups.
However, when efficacy of topiramte was analyzed, only 18.64% of the patients showed YMRS scores decrease more than 50% from baseline. Conclusions:
This study does not support the efficacy of topiramate as monotherapy in acute mania or mixed episodes in adolescents with bipolar I disorder and
sodium valproate was found superior to topiramate.
Pakistan Journal of Medical Sciences, 25(2) : 247-
252
- Year: 2009
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Anticonvulsants/mood stabilisers (excl. lithium)
Findling, R. L., Nyilas, M., Forbes, R. A., McQuade, R. D., Jin, N., Iwamoto, T., Ivanova, S., Carson, W. H., Chang, K.
Objectives: To determine the efficacy and safety of aripiprazole for the treatment of
pediatric bipolar I disorder, manic or mixed episode, with or without psychotic features. Method: Subjects were enrolled between March 2005 and
February 2007 in a randomized, multicenter, double-blind 4-week study of aripiprazole 10 mg/d, aripiprazole 30 mg/d, and placebo. Subjects (n = 296)
were 10 to 17 years old with a DSM-IV diagnosis of bipolar I disorder with current manic or mixed episodes, with or without psychotic features, and a
Young Mania Rating Scale (YMRS) score (greater-than or equal to) 20. The primary efficacy variable was change from baseline in the YMRS total score.
Results: Both doses of aripiprazole were superior to placebo on the YMRS total score beginning at week 1 and continuing through week 4. Aripiprazole
10 mg and 30 mg were more effective than placebo on global improvement, mania, and overall bipolar illness outcome measures. Response ((greater-than
or equal to)50% reduction in YMRS total score) at week 4 was achieved by 44.8%, 63.6%, and 26.1% of subjects in the aripiprazole 10 mg, aripiprazole
30 mg, and placebo groups, respectively (P < .01 both doses vs placebo). Both doses were generally well tolerated. The most common adverse events
were extrapyramidal disorder and somnolence; rates were higher for aripiprazole 30 mg compared with aripiprazole 10 mg. Average weight gain was not
significantly different between the aripiprazole 10 mg (+0.82 kg) or 30 mg (+1.08 kg) groups compared with the placebo group (+0.56 kg) (P = .35 and
P = .13, respectively). Conclusions: Aripiprazole in daily doses of 10 mg or 30 mg is an effective and generally well-tolerated acute treatment for
pediatric subjects with bipolar I mania or mixed episodes. Trial Registration: clinicaltrials.gov Identifier: NCT00110461 (copyright) Copyright 2009
Physicians Postgraduate Press, Inc.
Journal of Clinical Psychiatry, 70(10) : 1441-
1451
- Year: 2009
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Atypical Antipsychotics (second
generation)
Delbello, M. P., Chang, K., Welge, J. A., Adler, C. M., Rana, M., Howe, M., Bryan, H., Vogel, D., Sampang, S., mDelgado, S. V., Sorter, M., Strakowski, S. M.
Objective: To conduct a pilot study comparing the effects of quetiapine and placebo for the treatment of depressive episodes
in adolescents with bipolar I disorder. Method: Thirty-two adolescents (ages 12-18 years) with a depressive episode associated with bipolar I
disorder were randomized to eight weeks of double-blind treatment with quetiapine, 300-600 mg/day, or placebo. This two-site study was conducted from
March 2006 through August 2007. The primary efficacy measure was change in Children's Depression Rating Scale-Revised Version (CDRS-R) scores from
baseline to endpoint. Secondary efficacy measures included change in CDRS-R scores over the eight-week study period (PROC MIXED), changes from
baseline to endpoint in Hamilton Anxiety Rating Scale (HAM-A), Young Mania Rating Scale (YMRS), and Clinical Global Impression-Bipolar Version
Severity (CGI-BP-S) scores, as well as response and remission rates. Safety and tolerability were assessed weekly. Results: There was no
statistically significant treatment group difference in change in CDRS-R scores from baseline to endpoint (p = 0.89, effect size = -0.05, 95%
confidence interval: -0.77-0.68), nor in the average rate of change over the eight weeks of the study (p = 0.95). Additionally, there were no
statistically significant differences in response (placebo = 67% versus quetiapine = 71%) or remission (placebo = 40% versus quetiapine = 35%) rates,
or change in HAM-A, YMRS, or CGI-BP-S scores (all p > 0.7) between treatment groups. Dizziness was more commonly reported in the quetiapine (41%)
than in the placebo (7%) group (Fisher's exact test, p = 0.04). Conclusions: The results suggest that quetiapine monotherapy is no more effective
than placebo for the treatment of depression in adolescents with bipolar disorder. However, limitations of the study, including the high placebo
response rate, may have contributed to our findings and should be considered in the design of future investigations of pharmacological interventions
for this population. (copyright) 2009 The Authors Journal compilation (copyright) 2009 John Wiley & Sons A/S.
Bipolar Disorders, 11(5) : 483-
493
- Year: 2009
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Atypical Antipsychotics (second
generation)
Arbaizar, Beatriz, Dierssen-Sotos, Trinidad, Gomez-
Acebo, Ines, Llorca, Javier
Objective: Methods: Results: Conclusion: We performed meta-analyses to obtain
pooled estimates from controlled clinical trials on the efficacy of aripiprazole in major depression disorder and manic phase of bipolar disorder.A
search was performed in Medline/PubMed using \"aripiprazole\" AND \"depressive disorder\" and \"aripiprazole\" AND \"bipolar disorder\" as keywords,
and \"randomized controlled trial\" as limit. The last search was performed by April 30, 2009. References in the selected articles were revised to
identify other studies. We selected four placebo-controlled clinical trials on aripiprazole's effect on major depression, and three on
aripiprazole's effect on bipolar disorder. Studies performed in patients with comorbidity or devoted to measuring the effect of aripiprazole for
maintenance therapy were excluded. We extracted, in duplicate, data on number of patients, withdrawals, changes in Montgomery-Asberg Depression
Rating Scale and Young Mania Rating Scale (YMRS), response and remission rates, and side effects.Aripripazole is effective in increasing response
rates in depressive patients (response rate in the aripiprazole group minus response rate in the placebo group: 7.7%, 95% CI: 1.5-14.2) and manic
patients (difference in response rates: 15.7%, 95% CI: 9.7-21.8). It also improves by 3 points the scores in YMRS. Evidence of improving remission
rates is unavailable. Some side effects were more frequent in patients taking aripiprazole; this was the case of akathisia, especially in depressive
trials (rate difference: 20.3%, 95% CI: 16.9-23.7), and nausea in manic patients (rate difference: 10.5%, 95% CI: 7.4-13.5). Insomnia and
restlessness were also more frequent in depressive patients taking aripiprazole.We found evidence suggesting that aripiprazole is effective in both
depressive and manic patients, but has relevant side effects. Further research is needed to identify its benefits for comorbid patients and its
long-term effect.
General Hospital Psychiatry, 31(5) : 478-483
- Year: 2009
- Problem: Bipolar Disorders
- Type: Systematic reviews
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Atypical Antipsychotics (second
generation)
Azorin, Jean-Michel, Kaladjian, Arthur
Background: Objective: Methods: Results/conclusions: Although depression accounts for a large part of the burden associated with bipolar
disorder, its drug treatment has been under-studied.To provide the best available evidence supporting the pharmacotherapy of bipolar depression.A
systematic review was conducted, focusing on randomized, controlled trials (RCTs) and meta-analyses.Despite FDA approval of both the olanzapine-
fluoxetine combination and quetiapine for the treatment of acute bipolar depression, independent RCTs (i.e., not trials conducted 'under the
umbrella' of a drug company) have not found any drug to have antidepressant effects similar to those seen in unipolar depression. A practice-based
suggestion, valuable for both short- and long-term treatment, might be to have a background of mood stabilizers and to add drugs, following one of
several treatment options, trusting to find a drug with a degree of effectiveness by trial and error. The list of drugs that could be used would
include all the current antidepressants, the olanzapine-fluoxetine combination and probably quetiapine too. Special features and situations might
also influence treatment options.
Expert Opinion on Pharmacotherapy, 10(2) : 161-172
- Year: 2009
- Problem: Bipolar Disorders
- Type: Systematic reviews
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any)
Beynon, S., Soares-Weiser, K., Woolacott, N., Duffy, S., Geddes, J. R.
We conducted a systematic review and meta-analysis of randomised and quasi-
randomised controlled trials evaluating all clinically relevant pharmacological interventions for the prevention of relapse in people with bipolar
disorder. Thirty-four trials were included in the review. Direct comparisons with placebo and with lithium were available for most drugs. In
addition, there were direct comparisons of valproate vs. olanzapine, imipramine vs. lithium plus imipramine, olanzapine plus mood stabilisers vs.
mood stabilisers and perphenazine plus mood stabilisers vs. mood stabilisers. Methodological quality varied across studies and the strength of
evidence was not equal for all treatments or for all comparisons. There is evidence from placebo-controlled trials for the efficacy of lithium,
valproate and lamotrigine as maintenance therapy for the prevention of relapse in bipolar disorder. Three drugs have a significant effect in the
prevention of manic relapses (lithium, olanzapine and aripiprazole) and three in the prevention of depressive symptoms (valproate, lamotrigine and
imipramine). Imipramine is little used in practice, because of concern about adverse effects. The significant effects of olanzapine and aripiprazole
were demonstrated in selected responsive bipolar I patients only. Despite widespread use in clinical practice, there is little evidence to support
the efficacy of combination therapy.
Journal of Psychopharmacology, 23(5) : 574-
591
- Year: 2009
- Problem: Bipolar Disorders
- Type: Systematic reviews
-
Stage: Relapse prevention
-
Treatment and intervention: Biological Interventions
(any)
Fristad, Mary A., Verducci, Joseph S., Walters,
Kimberly, Young, Matthew E.
Context:
Childhood mood disorders lack sufficient evidence- based treatments. While psychosocial treatments are recommended for both childhood depression and
bipolar disorder, empirical support is scarce. Objective: To determine whether adjunctive multifamily psychoeducational psychotherapy would improve
outcome for children aged 8 to 12 years with depression or bipolar disorder. Design: One hundred sixty-five children were studied in a randomized
controlled trial of multifamily psychoeducational psychotherapy plus treatment as usual (n=78) compared with a wait-list control (WLC) condition plus
treatment as usual (n=87). Assessments occurred at baseline and at 6, 12, and 18 months. Intervention occurred between baseline and 6 months for the
immediate treatment group and between 12 and 18 months for the WLC group. Setting: University medical center. Participants: Children were recruited
from mental health and physical health care providers, media contacts, and word of mouth. All had a major mood disorder (major depressive disorder or
dysthymic disorder, 30%; bipolar disorder type I, type II, or not otherwise specified, 70%). Intervention: Children and 1 or more parents
participated in eight 90-minute multifamily psychoeducational psychotherapy sessions. Parent and child groups met separately but began and ended
sessions together. Main Outcome Measures: The Mood Severity Index (MSI) combines Mania Rating Scale and Children's Depression Rating Scale - Revised
scores. Results: Multifamily psychoeducational psychotherapy plus treatment as usual was associated with lower MSI scores at follow-up in intent-to-
treat analyses compared with WLC plus treatment as usual. The WLC group showed a similar decrease in MSI scores 1 year later, when also following
their treatment. Conclusion: Brief, adjunctive psychoeducational group psychotherapy is associated with improved outcome for children aged 8 to 12
years with major mood disorders. (PsycINFO Database Record (c) 2010 APA, all rights reserved)
Archives of General Psychiatry, 66(9) : 1013-1020
- Year: 2009
- Problem: Bipolar Disorders, Depressive Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Psychological Interventions
(any), Psychoeducation
Nandagopal, J. J., DelBello, M. P., Kowatch,
R.
Bipolar disorder (BPD) is being diagnosed with increasing frequency in the pediatric population as the
phenomenology of this disorder is becoming more clearly delineated. Early diagnosis and treatment of pediatric BPD is important to minimize
psychosocial disability and improve prognosis. Traditional mood stabilizers and atypical antipsychotic agents are frequently used to treat BPD in
youth, and there are emerging data to support their use in this population. This article provides a review of the literature on appropriate
pharmacologic treatment strategies for BPD in children and adolescents. The complex treatment issues of comorbid BPD and attention
deficit/hyperactivity disorder also are addressed. (copyright) 2009 Elsevier Inc. All rights reserved.
Child & Adolescent Psychiatric Clinics of North America, 18(2) : 455-
469
- Year: 2009
- Problem: Bipolar Disorders
- Type: Systematic reviews
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any)
Miklowitz, David J., Scott, Jan
Objectives: Methods: Results: Conclusions: Randomized trials of adjunctive psychotherapy for bipolar
disorder are reviewed, in tandem with discussion of cost-effectiveness, mediating mechanisms, and moderators of effects.Systematic searches of the
MEDLINE and PSYCHLIT databases yielded 19 randomized controlled trials of individual family and group therapies. Outcome variables included time to
recovery, relapse or recurrence, symptom severity, medication adherence, and psychosocial functioning.Meta-analyses consistently show that disorder-
specific psychotherapies [cognitive-behavioral therapy (CBT), interpersonal, family, and group] augment mood stabilizers in reducing rates of relapse
(OR = 0.57; 95% CI: 0.39-0.82) over 1-2 years. Specific mediating mechanisms include, but are not limited to, increasing medication adherence,
teaching self-monitoring and early intervention with emergent episodes, and enhancing interpersonal functioning and family communication. All
therapies have strengths and weaknesses. One group psychoeducation trial, demonstrated effect sizes for recurrence that are at least equivalent to
individual therapies, but findings await replication. Family interventions have been successfully administered in both single and multi-family
formats, but no studies report the comparative cost-effectiveness of these formats. The best-studied psychotherapy modality, CBT, can have beneficial
effects on depression, but findings are inconsistent across studies and vary with sample characteristics and comparison treatments.Adjunctive
psychotherapies can be cost-effective when weighed against observed reductions in recurrence, hospitalization and functional impairments. Future
trials need to (i) clarify which populations are most likely to benefit from which strategies; (ii) identify putative mechanisms of action; (iii)
systematically evaluate costs, benefits, and generalizability; and (iv) record adverse effects. The application of psychosocial interventions to
young-onset populations deserves further study.
Bipolar Disorders, 11 Suppl 2 : 110-
122
- Year: 2009
- Problem: Bipolar Disorders
- Type: Systematic reviews
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Psychological Interventions
(any)
Miklowitz, D. J., Axelson, D. A., George, E.
L., Taylor, D. O., Schneck, C. D., Sullivan, A. E., Dickinson, L. M., Birmaher, B.
Objective: Family interventions have been found to be effective in pediatric bipolar disorder (BD). This study examined the moderating
effects of parental expressed emotion (EE) on the 2-year symptomatic outcomes of adolescent BD patients assigned to family-focused therapy for
adolescents (FFT-A) or a brief psychoeducational treatment (enhanced care [EC]). Method: A referred sample of 58 adolescents (mean age 14.5 (plus or
minus)1.6 years, range 13-17 years) with BD I, II, or not otherwise specified was randomly allocated after a mood episode to FFT-A or EC, both with
protocol pharmacotherapy. Levels of EE (criticism, hostility, or emotional overinvolvement) in parents were assessed through structured interviews.
Adolescents and parents in FFT-A underwent 21 sessions in 9 months of psychoeducation, communication training, and problem-solving skills training,
whereas adolescents and parents in EC underwent 3 psychoeducation sessions. Independent \"blind\" evaluators assessed adolescents' depressive and
manic symptoms every 3 to 6 months for 2 years. Results: Parents rated high in EE described their families as lower in cohesion and adaptability than
parents rated low in EE. Adolescents in high-EE families showed greater reductions in depressive and manic symptoms in FFT-A than in EC. Differential
effects of FFT-A were not found among adolescents in low-EE families. The results could not be attributed to differences in medication regimens.
Conclusions: Parental EE moderates the impact of family intervention on the symptomatic trajectory of adolescent BD. Assessing EE before family
interventions may help determine which patients are most likely to benefit from treatment. J. Am. Acad. ChildAdolesc. (copyright) 2009 by the
American Academy of Child and Adolescent Psychiatry.
Journal of the American Academy of Child & Adolescent
Psychiatry, 48(6) : 643-651
- Year: 2009
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Psychological Interventions
(any), Psychoeducation, Other Psychological Interventions