TY - JOUR
T1 - Attrition factors in clinical trials of comorbid bipolar and substance-related disorders
AU - Nomamiukor, Nicole
AU - Brown, E. Sherwood
N1 - Funding Information:
The studies from which the data for this paper were derived were funded by the Stanley Medical Research Institute and an investigator-initiated grant from AstraZeneca. In addition, GlaxoSmithKline provided lamotrigine for one study. AstraZeneca provided feedback on the design of the quetiapine trial. Sponsors were not involved in the data analysis or interpretation of the findings presented in this report.
Funding Information:
Dr. E. Sherwood Brown has research grants from AstraZeneca, Forest Laboratories, GlaxoSmithKline, McNeil, NIAAA, and the Stanley Medical Research Institute. Nicole Nomamiukor has no conflict of interest to disclose.
PY - 2009/1
Y1 - 2009/1
N2 - Background: This study analyzed and defined specific factors that account for attrition in clinical research for patients with bipolar and substance-related disorders. Methods: Data were analyzed from two completed studies: an open-label trial of lamotrigine in patients with bipolar disorder (BPD) and cocaine-related disorder, and a placebo-controlled trial of quetiapine in patients with BPD and alcohol-related disorders. Correlations and Independent sample t-tests were performed to assess the impact of baseline characteristics including on length of study participation. Significance was set at the p = 0.05 level. Results: In the lamotrigine-treated patients, the presence of an amphetamine-related disorder, in addition to cocaine-related disorders, was associated with a shorter time in the study. In the quetiapine-treated patients higher scores on the Addiction Severity Index Legal subscale were associated with shorter length in the study. The presence of panic disorder was associated with shorter time in both studies. Limitations: Although the data were taken from the two largest clinical trials, to date, in patients with BPD and substance-related disorders, the sample sizes were relatively modest. In addition, the baseline assessments were somewhat different in the two studies limiting our ability to make conclusions on differences between patients with BPD and cocaine use versus alcohol use. Conclusions: This study adds to an emerging literature on the significance of panic disorder in patients with BPD.
AB - Background: This study analyzed and defined specific factors that account for attrition in clinical research for patients with bipolar and substance-related disorders. Methods: Data were analyzed from two completed studies: an open-label trial of lamotrigine in patients with bipolar disorder (BPD) and cocaine-related disorder, and a placebo-controlled trial of quetiapine in patients with BPD and alcohol-related disorders. Correlations and Independent sample t-tests were performed to assess the impact of baseline characteristics including on length of study participation. Significance was set at the p = 0.05 level. Results: In the lamotrigine-treated patients, the presence of an amphetamine-related disorder, in addition to cocaine-related disorders, was associated with a shorter time in the study. In the quetiapine-treated patients higher scores on the Addiction Severity Index Legal subscale were associated with shorter length in the study. The presence of panic disorder was associated with shorter time in both studies. Limitations: Although the data were taken from the two largest clinical trials, to date, in patients with BPD and substance-related disorders, the sample sizes were relatively modest. In addition, the baseline assessments were somewhat different in the two studies limiting our ability to make conclusions on differences between patients with BPD and cocaine use versus alcohol use. Conclusions: This study adds to an emerging literature on the significance of panic disorder in patients with BPD.
KW - Alcohol
KW - Attrition
KW - BPD
KW - Cocaine
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U2 - 10.1016/j.jad.2008.04.016
DO - 10.1016/j.jad.2008.04.016
M3 - Article
C2 - 18511129
AN - SCOPUS:56249103097
SN - 0165-0327
VL - 112
SP - 284
EP - 288
JO - Journal of affective disorders
JF - Journal of affective disorders
IS - 1-3
ER -