Hamer and Simpson address several limitations in the analyses in our article, principally
raising questions about the number of tests conducted and the possibility of a type
1 error. Bipolar disorder, especially rapid cycling, does pose difficulties in terms
of establishing dependent variables and conducting statistical tests. Inherently,
this is because improvement in index symptomatology, worsening of symptomatology,
assessment of some measure of global severity of illness, and number and frequency
of episodes are all fundamentally important. Further, changes can be principally captured
as categorical improvement or mean change. Unlike a condition such as hypertension,
a single measure cannot provide an adequate proxy for the multiple dimensional components
of the disease. We have addressed these methodological issues in recent publications
(
Bowden et al 1997
,
Calabrese et al 1999
). We tested three dependent measures. If a Bonferoni correction is applied, this would
result in an α value of .017 as equivalent to a nominal .05. As we state, these tests
were conducted at endpoint on the intent to treat sample, with last observation carried
forward, not, as Hamer and Simpson suggest, on multiple time points.To read this article in full you will need to make a payment
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References
- Maintenance clinical trials in bipolar disorder.Psychopharmacol Bull. 1997; 33: 693-699
- A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression.J Clin Psychiatry. 1999; 60: 79-88
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© 1999 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.