Document Detail

Characterizing onset in psychopharmacological clinical trials.
MedLine Citation:
PMID:  7675985     Owner:  NLM     Status:  MEDLINE    
In addition to describing treatment efficacy in terms of changes in rating scale scores, the distributions of time to occurrence of major clinical events such as onset and response are clinically important information. Issues in the design, conduct and analysis of clinical trials in which the time to onset of effect or time to response is to be characterized are discussed. A criterion must be defined to signal that the clinical event has occurred. Onset properties are given in terms of (1) the probability of obtaining onset and (2) for patients who obtain onset, the distribution of time to onset. A statistical model and methods to estimate parameters and compare onset times of treatments are described. A simple formula that can be used to aid in clinical decision making as to when to alter treatment if onset has not yet occurred is presented.
E M Laska; C Siegel
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, P.H.S.; Review    
Journal Detail:
Title:  Psychopharmacology bulletin     Volume:  31     ISSN:  0048-5764     ISO Abbreviation:  Psychopharmacol Bull     Publication Date:  1995  
Date Detail:
Created Date:  1995-10-17     Completed Date:  1995-10-17     Revised Date:  2009-11-11    
Medline Journal Info:
Nlm Unique ID:  0101123     Medline TA:  Psychopharmacol Bull     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  29-35     Citation Subset:  IM    
Nathan S. Kline Institute for Psychiatric Research, Statistical Sciences & Epidemiology Division 10962, USA.
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MeSH Terms
Clinical Trials as Topic*
Mental Disorders / drug therapy*,  psychology
Psychotropic Drugs / therapeutic use*
Research Design*
Time Factors
Grant Support
Reg. No./Substance:
0/Psychotropic Drugs

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