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Clinical and regulatory implications of active run-in phases in long-term studies for bipolar disorder

Abstract:

Objective: The integration of new treatments into the market and routine clinical practice should be dependent on robustness of evidence from randomised controlled trials (RCTs). We assessed study designs of long-term studies for bipolar disorder of all second-generation antipsychotics (SGAs) submitted to the Food and Drug Administration (FDA) and the completeness of evidence submitted to the regulatory agency. Method: Systematic review of double-blind RCTs comparing SGAs with placebo or acti...

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Publisher copy:
10.1111/acps.12223

Authors


More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Psychiatry
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Psychiatry
Role:
Author
Publisher:
Blackwell Publishing Ltd
Journal:
Acta Psychiatrica Scandinavica More from this journal
Volume:
129
Issue:
5
Pages:
328-342
Publication date:
2014-01-01
DOI:
EISSN:
1600-0447
ISSN:
0001-690X
Language:
English
Keywords:
Pubs id:
pubs:463523
UUID:
uuid:0b739a6c-b47b-45ed-81ae-5823efddc0eb
Local pid:
pubs:463523
Source identifiers:
463523
Deposit date:
2014-06-17

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