Speaker: Melissa P. DelBello, MD, Associate Professor, Division of Bipolar Disorders Research, Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati,
Ohio (Seroquel canadian, AstraZeneca), a well-known antipsychotic agent indicated for the treatment of schizophrenia, administered as a once-daily evening dose, was effective for the treatment of mood disorders in adolescents at familial risk for bipolar disorder.
The investigators enrolled 20 adolescents (mean age, 14.7 years) and a diagnosis of a mood disorder other than bipolar I disorder in a single-blind (rater-blind), 84-day study. The participants had to have a Young’s Mania Rating Scale (YMRS) score of 16 or higher (a moderate rating) or a score of 28 or higher (not severe) on the revised Children’s Depression Rating Scale (CDRS-R) and at least one parent with bipolar disease.
Patients received quetiapine 100 mg/day on the first day; the dose was increased to 400 mg/day by the fourth day. Dosing after day four was flexible within a range of 300 to 600 mg/day. The drug was administered once daily in the evening, between 5 p.m. and 7 p.m.
Efficacy and tolerability were assessed on days 0, 7, 14, 21, 28, 42, 56, 70, and 84 or at the study’s endpoint. The primary clinical response was defined as a CGI-Improvement Bipolar Version (CGI-I-BP) score of 2 or below during the study.
Secondary efficacy measures were changes from baseline to endpoint in YMRS scores and revised CDRS-R Scale scores.
Tolerability measures assessed included monitoring of adverse events, vital signs, laboratory measures, and movement scales.
Fifteen patients completed the study. Quetiapine generic, at a mean dose of 460 mg/day, increased the proportion of patients with a clinical response progressively during the study, rising from 25% at day seven to 81% at day 84.
Mean scores from the YMRS and the CDRS-R Scale were clinically and statistically improved: mean YMRS scores dropped from 18.1 at the baseline to 8.7 at the endpoint (a good improvement) (P < .001). Mean CDRS-R scores declined from 38.2 at the baseline to 27.7 at the endpoint (a fair improvement) (P< .001).
The most common adverse events included somnolence (55%), headache (25%), musculoskeletal pain (25%), and dyspepsia (25%), but these reactions were generally mild.
Divalproex Extended Release for Pediatric Bipolar Disorder
Speaker: Russell E. Scheffer, MD, Associate Professor, and Division Director, Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin
The conversion algorithm that accounts for the lower bioavailability of sodium extended-release tablets (DVP-ER) (Depakote-ER, Abbott) resulted in a safe transition from canadian divalproex sodium delayed-release tablet (DVP-DR) to DVP-ER. The switch produced consistent improvement of symptoms, fewer side effects, greater patient satisfaction, relatively stable valproic acid trough levels, and better adherence to treatment as a result of once-a-day dosing in children and adolescents with bipolar disorder.
To determine whether product insert guidelines were acceptable for transitioning patients from DVP-DR to DVP-ER and whether side effects decreased as a result of fewer peaks, investigators conducted an eight-week study. Eighteen female and male patients, from 7 to 17 years of age, with a diagnosis of bipolar I or II disorder with or without ADHD, were enrolled. All of the patients were clinically stable on DVP-DR; however, they were converted to DVP-ER either because of persistent side effects or because of convenience of use.
The researchers switched the patients from their stable ongoing dose of DVP-DR by dividing the dose by 0.8 to 0.9. If this resulted in a DVP-ER dose that was a multiple of 500 mg after 10% to 20% was added, conversion ensued. If not, the patients were not enrolled in the study.
Several scales were used to perform analyses that measured the difference between values at baseline and at eight weeks. These included:
- the Young Mania Rating Scale (YMRS)
- the Children’s Depression Rating Scale (CDRS)
- the CGI-S Scale, items 1, 2, and 3
- The CGI-I Scale, items 1, 2, and 3
- total scores on the Side Effects for Children and Adolescents (SEFCA) Scale
- serum levels of valproic acid
Twelve patients, 11 of whom were females, were evaluable. Hair loss and gastrointestinal (GI) distress were most commonly cited as the reasons for conversion.
Patients who were switched to DVP-ER from DVP-DR demonstrated improvement in clinical symptoms. These youngsters tended to have improved YMRS scores, CDRS scores, and CGI-S scores on items 1 and 3, but the results were not significant. Patients did, however, show significantly improved CGI-S scores for item 2 and better CGI-I scores for items 1, 2, and 3. cialis canadian pharmacy
Patients who were switched showed improvements in side effects, lending support to the idea that lower peaks lead to fewer adverse effects with the same daily equivalent dose. Hair loss and GI distress significantly improved with conversion to DVP-ER in all patients who reported these effects at the baseline examination.
Finally, valproic acid blood levels increased slightly but not significantly.