Developing the BALANCE trial – the role of the pilot study and start‐up phase

Rendell, Jennifer M; Juszczak, Ed; Hainsworth, Jane; Gucht, Emma van der; Healey, Christine; Morriss, Richard; Ferrier, Nicol; Young, Allan H.; Young, Heather; Goodwin, Guy M.; Geddes, John

doi:10.1046/j.1399-5618.2003.00088.x

Cited by 22 publications

(12 citation statements)

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“…The multi-center BALANCE (Bipolar Affective disorder: Lithium/ANticonvulsant Comparative Evaluation) trial has recently compared the effectiveness of valproate monotherapy, lithium monotherapy and lithium and valproate combination in maintenance treatment but at the time of writing the results are unavailable [53].…”

Section: Combination Of An Antipsychotic and Valproate In Maintenancementioning

confidence: 99%

A review of valproate in psychiatric practice

Haddad

Das

Ashfaq

et al. 2009

Expert Opinion on Drug Metabolism & Toxicology

122

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Valproate (2-propylpentanoate) is available as valproic acid, sodium valproate and semisodium valproate. It has actions on dopamine, GABA and glutamate neurotransmission and intracellular signaling. Its main psychiatric use is to treat bipolar disorder. It has been used in other psychiatric disorders, including schizophrenia and borderline personality disorder, but data are insufficient to recommend this. In acute mania, valproate monotherapy has similar efficacy to antipsychotic drugs and lithium whereas the combination of valproate and an antipsychotic is more effective than either drug alone. In maintenance treatment of bipolar disorder, valproate monotherapy has comparable efficacy to olanzapine although placebo-controlled evidence is limited. Maintenance treatment with valproate and quetiapine or olanzapine is more efficacious than valproate alone when an acute episode responds to the combination. Common adverse effects of valproate include weight gain, gastrointestinal symptoms, sedation, tremor and mild elevation of hepatic enzymes. Serious hepatic toxicity is rare in adults. Many adverse effects are dose related and resolve with dose reduction. Valproate is teratogenic and specifically associated with neural tube defect. Preliminary evidence has linked in utero exposure to decreased verbal intelligence in the offspring. These effects, plus a probable increased risk of polycystic ovary syndrome, limit valproate's use in women of childbearing potential.

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Section: Combination Of An Antipsychotic and Valproate In Maintenancementioning

confidence: 99%

A review of valproate in psychiatric practice

Haddad

Das

Ashfaq

et al. 2009

Expert Opinion on Drug Metabolism & Toxicology

122

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“…BALANCE (bipolar affective disorder: lithium/anticonvulsant evaluation), funded by the Stanley Foundation, is an example of how such trials can be installed. After a run-in phase, during which they receive a combination of lithium and valproate for up to 8 weeks, patients will be randomized to receive lithium/valproate as monotherapy or combination treatment, and will be followed up for 2 years [90, 91]. The trial is open to any patient with bipolar disorder who agrees to commence maintenance treatment, but faces clinical uncertainty about the optimal treatment.…”

Section: Discussionmentioning

confidence: 99%

Bipolar (Spectrum) Disorder and Mood Stabilization: Standing at the Crossroads?

Fruyt

Demyttenaere²

2007

Psychother Psychosom

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Diagnosis and treatment of bipolar disorder has long been a neglected discipline. Recent years have shown an upsurge in bipolar research. When compared to major depressive disorder, bipolar research still remains limited and more expert based than evidence based. In bipolar diagnosis the focus is shifting from classic mania to bipolar depression and hypomania. There is a search for bipolar signatures in symptoms and course of major depressive episodes. The criteria for hypomania are softened, leading to a bipolar prevalence that now equals that of major depressive disorder. Anti-epileptics and atypical antipsychotics have joined lithium in the treatment of bipolar disorder. Fortunately, mood stabilization has become the core issue in bipolar disorder treatment. In contrast with recent trends in the diagnosis of bipolar disorder, treatment research remains more focused on classic mania than depression or hypomania. This leaves the clinician with the difficult task of diagnosing ‘new bipolar patients’ for whom no definite evidence-based treatment is available. An important efficacy-effectiveness gap further compromises the translation of the evidence base on bipolar disorder treatment into clinical practice. The recent upsurge of research on bipolar disorder is to be applauded, but further research is needed: for bipolar disorder in general, and for bipolar depression and the long-term treatment specifically. Given the complexity of the disorder and the many clinical uncertainties, effectiveness studies should be installed.

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“…The BALANCE is a multicentre, UK and US, randomized trial comparing lithium, divalproex and lithium and divalproex in combination (42). The pilot study and start‐up phase have identified a number of pragmatic refinements to promote recruitment and follow‐up including: the dropping of masking (blinding) of participants and clinicians, the introduction of postal medication delivery and fewer follow‐up appointments (43). The study plans to randomize as many participants as possible before the end of 2005 and will assess whether the combination treatment arm is more effective in preventing hospital admission over a 2‐year period than either monotherapy.…”

Section: Discussionmentioning

confidence: 99%