Seroquel Adjunctive therapy offers significant benefits over mood stabilisation monothrapy

November 30, 2001

Results from a first-ever controlled study evaluating efficacy and safety of antipsychotic treatment in adolescent bipolar disorder demonstrate that adding the atypical antipsychotic Seroquel (quetiapine) to mood stabilisation therapy is significantly more effective than mood stabilisation alone. The data, presented today at the 2nd International Forum on Mood and Anxiety Disorders (IFMAD) in Monte Carlo, highlight that mood stabilisation monotherapy is often not enough to treat the symptoms of this illness, and adding quetiapine to existing treatment would benefit a high percentage of young patients.

Conducted by Professor Melissa DelBello, MD of the University of Cincinnati College of Medicine, USA, the study1 evaluated efficacy of quetiapine and divalproex as combination therapy, to divalproex monotherapy in adolescents with bipolar disorder. It found the quetiapine group to be significantly more effective in reducing symptoms in significantly more patients, than divalproex alone. Additionally, quetiapine was shown to be exceptionally well-tolerated by the adolescent patients.

"These results are extremely important and exciting as this is the first time a controlled study evaluated efficacy and safety of antipsychotic treatment in adolescents with bipolar disorder," commented Professor DelBello. "Our findings indicate that adding quetiapine to divalproex reduces psychotic symptoms in significantly more patients - statistically speaking - with this traumatic illness, than divalproex monotherapy. This is very encouraging, as nearly half of adolescents with bipolar disorder fail to respond to initial treatment with lithium or divalproex monotherapy.

"Our study also showed quetiapine to be exceptionally well-tolerated," continued Professor DelBello, "causing no treatment emergent extrapyramidal symptoms (EPS). These distressing and disabling movement disorders can occur as side effects and often lead to treatment non-compliance. What our data suggests is that not only can we increase chances of a successful recovery, but we can do so without subjecting our young patients to these devastating side effects."

The double-blind, placebo-controlled study randomised use of quetiapine (mean dose: 432mg/day) versus placebo in combination with divalproex, in 30 adolescent patients with bipolar disorder (mean age: 14 years) for six weeks. The results indicated that 87 per cent of the quetiapine combination patient group had a 50 per cent or greater reduction in YMRS scores from baseline to study conclusion, compared to only 53 per cent in the divalproex monotherapy group. Furthermore, 86 per cent of the quetiapine combination group showed improvement in CGI scores, compared to 53 per cent in the divalproex monotherapy group. The quetiapine combination patient group did not experience any EPS, QTc prolongation or weight gain.

Since Seroquel is already an efficacious and well-tolerated treatment for schizophrenia, this news is encouraging for adolescents suffering from bipolar disorder.
'Seroquel' is a trade mark property of AstraZeneca

For further information, or for an interview with Melissa DelBello, please contact:
Antonia Betts or Oliver Rosenbauer, Shire Hall International
Tel. +44 (0) 207 471 1500

Or, for an electronic and downloadable version of this press release, please visit the psychiatry resource internet site at:

This psychiatry resource features educational materials relating to severe mental illness, including background information on schizophrenia as well as epidemiological data and treatment issues clinicians face in everyday practice.

Reference: 1DelBello MP, Rosenberg HL, Wilhoit SR, Seshadri V, Strakowski SM. Safety, tolerability and efficacy of quetiapine as adjunctive treatment for bipolar adolescents with mania. Poster presented at 2nd International Forum on Mood and Anxiety Disorders, Monte Carlo, Monaco.

Shire Hall Communications

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