Disorders - Bipolar Disorders
Kafantaris, Vivian, Coletti, Daniel J., Dicker, Robert, Padula, Gina, Pleak, Richard R., Alvir, Jose Maria J.
OBJECTIVE: There are no published placebo-controlled studies of
any agent in the treatment of acute mania in children or adolescents. This is the first placebo-controlled study of lithium's efficacy in the
treatment of acute mania in adolescents. METHOD: In this discontinuation study, participants received open treatment with lithium at therapeutic
serum levels (mean 0.99 mEq/L) for at least 4 weeks. Responders were randomly assigned to continue or discontinue lithium during a 2-week double-
blind, placebo-controlled phase. This study had 80% power to detect a 40% difference in exacerbation rates between groups (10% on lithium versus 50%
on placebo). RESULTS: Twenty-three of 40 protocol participants (57.5%) experienced a clinically significant symptom exacerbation during the 2-week
double-blind phase. However, the slightly lower exacerbation rate in the group maintained on lithium (10/19 or 52.6%) versus the group switched to
placebo (13/21 or 61.9%) did not reach statistical significance. CONCLUSIONS: This study does not support a large effect for lithium continuation
treatment of adolescents with acute mania, mostly due to the unexpectedly high rate of exacerbations in the group that continued on lithium. Further
studies are warranted to clarify whether acute mania in adolescents is lithium responsive.
Journal of the American Academy of Child & Adolescent
Psychiatry, 43(8) : 984-93
- Year: 2004
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Lithium, Medication dose
reduction/discontinuation
Pavuluri, Mani
N., Henry, David B., Carbray, Julie A., Sampson, Gwendolyn, Naylor, Michael W., Janicak, Philip G.,
OBJECTIVE: This prospective 6-
month open trial examined the safety and efficacy of two combination therapies for manic or mixed episodes of pediatric bipolar disorder: (1)
divalproex sodium plus risperidone (DVPX+Risp), or (2) lithium plus risperidone (Li+Risp). METHODS: Thirty-seven (37) subjects aged 5 and 18
(age=12.1+/-3.5 years) with DSM IV current mixed or manic episode and Young Mania Rating Scale (YMRS) score >20 were sequentially assigned to either
DVPX+Risp or Li+Risp in a 6-month, prospective open-label trial. Outcome measures included the YMRS, Clinical Global Impression Scale for Bipolar
Disorder (CGI-BP), Child Depression Rating Scale-Revised (CDRS-R) as well as measures of safety and tolerability. RESULTS: Effect sizes (Cohen's d)
based on change of YMRS scores from baseline were 4.36 for DVPX+Risp and 2.82 for Li+Risp. Response rates (>or=50% change from baseline YMRS score at
the end of study) were 80% for DVPX+Risp and 82.4% for Li+Risp. Both combination treatments were well tolerated. Significant improvements (p<0.001)
from baseline were seen for mean scores on all efficacy measures, i.e., YMRS, CGI-BP, and CDRS-R. There were no significant group differences in
safety or tolerability, and no serious adverse events during the 6-month trial. CONCLUSION: Both DVPX+Risp and Li+Risp show strong effects coupled
with safety and tolerability in treating children and adolescents with manic or mixed episodes associated with type I bipolar disorder.
Journal of Affective Disorders, 82 Suppl 1 : S103-
11
- Year: 2004
- Problem: Bipolar Disorders
- Type: Controlled clinical trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Atypical Antipsychotics (second
generation), Anticonvulsants/mood stabilisers (excl. lithium), Lithium
Rea, Margaret M., Tompson, Martha C., Miklowitz,
David J., Goldstein, Michael J., Hwang, Sun, Mintz, Jim
Recently hospitalized bipolar, manic patients (N = 53) were randomly
assigned to a 9-month, manual-based, family-focused psychoeducational therapy (n = 28) or to an individually focused patient treatment (n = 25). All
patients received concurrent treatment with mood-stabilizing medications. Structured follow-up assessments were conducted at 3-month intervals for a
1-year period ofactive treatment and a 1-year period of posttreatment follow-up. Compared with patients in individual therapy, those in family-
focused treatment were less likely to be rehospitalized during the 2-year study period. Patients in family treatment also experienced fewer mood
disorder relapses over the 2 years, although they did not differ from patients in individual treatment in their likelihood of a first relapse.
Results suggest that family psychoeducational treatment is a useful adjunct to pharmacotherapy in decreasing the risk of relapse and hospitalization
frequently associated with bipolar disorder.
Journal of Consulting & Clinical Psychology, 71(3) : 482-
92
- Year: 2003
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Relapse prevention
-
Treatment and intervention: Psychological Interventions
(any), Other Psychological Interventions
Colom, Francesco, Vieta, Eduard, Martinez-Aran, Anabel, Reinares, Maria, Goikolea, Jose Manuel, Benabarre, Antonio, Torrent, Carla, Comes, Merce, Corbella,
Barbara, Parramon, Gemma, Corominas, Josep
BACKGROUND: Studies on individual psychotherapy indicate that some
interventions may reduce the number of recurrences in bipolar patients. However, there has been a lack of structured, well-designed, blinded,
controlled studies demonstrating the efficacy of group psychoeducation to prevent recurrences in patients with bipolar I and II disorder. METHODS:
One hundred twenty bipolar I and II outpatients in remission (Young Mania Rating Scale score <6, Hamilton Depression Rating Scale-17 score <8) for at
least 6 months prior to inclusion in the study, who were receiving standard pharmacologic treatment, were included in a controlled trial. Subjects
were matched for age and sex and randomized to receive, in addition to standard psychiatric care, 21 sessions of group psychoeducation or 21 sessions
of nonstructured group meetings. Subjects were assessed monthly during the 21-week treatment period and throughout the 2-year follow-up. RESULTS:
Group psychoeducation significantly reduced the number of relapsed patients and the number of recurrences per patient, and increased the time to
depressive, manic, hypomanic, and mixed recurrences. The number and length of hospitalizations per patient were also lower in patients who received
psychoeducation. CONCLUSION: Group psychoeducation is an efficacious intervention to prevent recurrence in pharmacologically treated patients with
bipolar I and II disorder.
Archives of General Psychiatry, 60(4) : 402-
7
- Year: 2003
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Relapse prevention
-
Treatment and intervention: Psychological Interventions
(any), Psychoeducation
Delbello, Melissa P., Schwiers, Michael L., Rosenberg, H. Lee, Strakowski, Stephen M.
OBJECTIVES: This randomized, double-blind, placebo-controlled study examined the efficacy and
tolerability of quetiapine in combination with divalproex (DVP) for acute mania in adolescents with bipolar disorder. It was hypothesized that DVP in
combination with quetiapine would be more effective than DVP alone for treating mania associated with adolescent bipolar disorder. Furthermore, it
was hypothesized that quetiapine would be well tolerated. METHOD: Thirty manic or mixed bipolar I adolescents (12-18 years) received an initial DVP
dose of 20 mg/kg and were randomly assigned to 6 weeks of combination therapy with quetiapine, which was titrated to 450 mg/day (n = 15) or placebo
(n = 15). Primary efficacy measures were change from baseline to endpoint in Young Mania Rating Scale (YMRS) score and YMRS response rate. Safety and
tolerability were assessed weekly. RESULTS: The DVP + quetiapine group demonstrated a statistically significantly greater reduction in YMRS scores
from baseline to endpoint than the DVP + placebo group (F(1,27) = 5.04, p =.03). Moreover, YMRS response rate was significantly greater in the DVP +
quetiapine group than in the DVP + placebo group (87% versus 53%; Fisher exact test, p =.05). No significant group differences from baseline to
endpoint in safety measures were noted. Sedation, rated as mild or moderate, was significantly more common in the DVP + quetiapine group than in the
DVP + placebo group. CONCLUSIONS: The findings of this study indicate that quetiapine in combination with DVP is more effective for the treatment of
adolescent bipolar mania than DVP alone. In addition, the results suggest that quetiapine is well tolerated when used in combination with DVP for the
treatment of mania.
Journal of the American Academy of Child & Adolescent Psychiatry, 41(10) : 1216-
23
- Year: 2002
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Atypical Antipsychotics (second
generation), Anticonvulsants/mood stabilisers (excl. lithium)
Fristad, Mary A., Goldberg-Arnold, Jill S., Gavazzi, Stephen M.
OBJECTIVES: Multi-
family psychoeducation groups (MFPG) have been developed and tested for adults, but not for children with bipolar disorder (BPD). We present data
from a pilot study of our manual-driven MFPG treatment for families of children with mood disorders and address two questions: Do families of
children with BPD and families of children with major depressive disorder/dysthymic disorder (MDD/DD): 1) differ at treatment entry?; 2) benefit
equally from intervention? METHOD: A total of 35 children (n=16, BPD; n=19, MDD/DD) aged 8-11 years and their parents were randomized into immediate
MFPG plus treatment as usual (TAU) or wait-list + TAU and assessed periodically. RESULTS: At baseline, there was a trend toward parents in BPD
families being more knowledgeable about mood symptoms than parents in MDD/DD families (p < 0.04). Additionally at baseline, children with BPD
evidenced greater mood severity historically and a trend toward more hospitalizations, day treatment, outpatient treatment, medication trials, and
placement in special education classrooms than children with MDD/DD. Immediately following and 4 months post-treatment, both BPD and MDD/DD families
described having gained knowledge, skills, support, and positive attitudes during treatment. MDD/DD families increased their knowledge of symptoms to
the same level as BPD families. CONCLUSIONS: While BPD families enter treatment with more impaired children and more extensive treatment histories,
both BPD and MDD/DD families benefit from intervention. The clinical issues concerning combining families of children with bipolar and depressive
spectrum illnesses in groups are discussed. Clinical impressions suggest that such combinations are clinically feasible and potentially
beneficial.
Bipolar
Disorders, 4(4) : 254-62
- Year: 2002
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Psychological Interventions
(any), Psychoeducation
Kowatch,
R. A., Suppes, T., Carmody, T. J., Bucci, J. P., Hume, J. H., Kromelis, M., Emslie, G. J., Weinberg, W. A., Rush, A. J.
OBJECTIVE: To develop effect
sizes for 3 mood stabilizers--lithium, divalproex sodium, and carbamazepine--for the acute-phase treatment of bipolar I or II disorder, mixed or
manic episode, in children and adolescents aged 8 to 18 years. METHOD: Forty-two outpatients with a mean age of 11.4 years (20 with bipolar I
disorder and 22 with bipolar II disorder) were randomly assigned to 6 weeks of open treatment with either lithium, divalproex sodium, or
carbamazepine. The primary efficacy measures were the weekly Clinical Global Impression Improvement scores and the Young Mania Rating Scale (Y-MRS).
RESULTS: Using a > or = 50% change from baseline to exit in the Y-MRS scores to define response, the effect size was 1.63 for divalproex sodium, 1.06
for lithium, and 1.00 for carbamazepine. Using this same response measure with the intent-to-treat sample, the response rates were as follows: sodium
divalproex, 53%; lithium, 38%; and carbamazepine, 38% (chi 2(2) = 0.85, p = .60). All 3 mood stabilizers were well tolerated, and no serious adverse
effects were seen. CONCLUSIONS: Divalproex sodium, lithium, and carbamazepine all showed a large effect size in the open treatment of children and
adolescents with bipolar I or II disorder in a mixed or manic episode.
Journal of the American Academy of Child & Adolescent
Psychiatry, 39(6) : 713-20
- Year: 2000
- Problem: Bipolar Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Anticonvulsants/mood stabilisers (excl. lithium), Lithium
Geller, Barbara, Cooper, Thomas B., Sun, Kai, Zimermann, Betsy, Frazier, Jeanne, Williams, Marlene, Heath, Janet
Performed a double-blind, placebo-controlled,
random assignment, parallel group, pharmacokinetically dosed study of lithium for adolescents with bipolar disorders (BDs) and temporally secondary
substance dependency disorders (SDDs). Ss were 12-18 yrs old and were comprehensively assessed during a 6-wk outpatients protocol that included
random weekly urine collection for drug assays and random and weekly serum collection for lithium levels. Using both intent-to-treat (N=25) and
completer (N=21) analyses, there were significant differences on continuous and categorical measures between the active and placebo groups for both
psychopathology measures and weekly random urine drug assays. The mean scheduled weekly serum lithium level of active responders was 0.9 mEq/L.
Addiction to both alcohol and marijuana was the most frequent category of SSD. Lithium treatment of BDs with secondary SDDs in adolescents was an
efficacious treatment for both disorders. (PsycINFO Database Record (c) 2007 APA, all rights reserved).
Journal of the American Academy of Child & Adolescent Psychiatry, 37(2) : 171-
178
- Year: 1998
- Problem: Bipolar Disorders, Substance Use Disorders (any)
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions
(any), Lithium