The proposed research will involve development and evaluation of psychometric rating scales and other instruments for data acquisition in clinical psychopharmacology research. Efforts will focus on, but not be restricted to, development of an instrument for characterizing and assessing acute anxiety and panic attacks in children, a scale for measuring the severity of dementia in elderly patients, and a multiphasic test battery for repeated assessment of treatment effects in patients with primary degenerative dementia. Actual participation in clinical psychopharmacology research is essential to accomplish those psychometric goals. Personnel will interview and/or test subjects in a double-blind, multiple crossover design study of the efficacy of oral physostigmine in senile dementia and a study alprazolam in blocking or ameliorating acute anxiety and panic attacks in children. Statistical issues which have become obvious in the drug industry or at FDA will be pursued by analytic and simulation methods. These include, but will not be restricted to, methodology for combining results from multiple independent drug trials, methodology for confirming the presence of a true treatment effect in some studies even though it may not be present in all of them, methodology for interim analysis of data from protracted clinical trails, and methodology for powerful analysis of non-Gaussian frequency count data.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
2R01MH032457-09
Application #
3375334
Study Section
(TDAB)
Project Start
1978-09-01
Project End
1989-08-31
Budget Start
1986-09-01
Budget End
1987-08-31
Support Year
9
Fiscal Year
1986
Total Cost
Indirect Cost
Name
University of Texas Health Science Center Houston
Department
Type
Schools of Medicine
DUNS #
City
Houston
State
TX
Country
United States
Zip Code
77225
Tonidandel, Scott; Overall, John E; Smith, Fraser (2004) Use of resampling to select among alternative error structure specifications for GLMM analyses of repeated measurements. Int J Methods Psychiatr Res 13:24-33
Overall, John E; Tonidandel, Scott (2002) Measuring change in controlled longitudinal studies. Br J Math Stat Psychol 55:109-24
Ahn, C; Overall, J E; Tonidandel, S (2001) Sample size and power calculations in repeated measurement analysis. Comput Methods Programs Biomed 64:121-124
Ahn, C; Tonidandel, S; Overall, J E (2000) Issues in use of SAS PROC.MIXED to test the significance of treatment effects in controlled clinical trials. J Biopharm Stat 10:265-86
Overall, J E; Ahn, C; Shivakumar, C et al. (1999) Problematic formulations of SAS PROC.MIXED models for repeated measurements. J Biopharm Stat 9:189-216
Overall, J E; Atlas, R S (1999) Power of univariate and multivariate analyses of repeated measurements in controlled clinical trials. J Clin Psychol 55:465-85
Overall, J E; Shivakumar, C (1999) Testing differences in response trends across a normalized time domain. J Clin Psychol 55:857-67
Overall, J E; Shobaki, G; Shivakumar, C et al. (1998) Adjusting sample size for anticipated dropouts in clinical trials. Psychopharmacol Bull 34:25-33
Overall, J E; Shobaki, G; Anderson, C B (1998) Comparative evaluation of two models for estimating sample sizes for tests on trends across repeated measurements. Control Clin Trials 19:188-97
Overall, J E (1997) Drop-outs and a random regression model. J Biopharm Stat 7:383-402

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