Class 19
Focus on the study of the new serotonin-uptake inhibiting agent, SN-X95 in patients with General Anxiety Disorder (GAD).
Subjects: 52 subjects diagnosed with GAD.
Groups: Randomly assigned to one of three treatment groups:
25 mg SN-X95 (Lo-Dose)
100 mg SN-X95 (Hi-Dose)
Placebo
Duration: 10 weeks of daily oral dosing, double-blind study.
Measurement Tool: Hamilton Rating Scale for Anxiety (HAM-A), scoring from 0 to 56 (higher indicates more anxiety).
Random Variable: The HAM-A scores.
Variable Type: Continuous variable.
Parameter of Interest: Mean HAM-A test scores.
Groups for Comparison: Three groups (Lo-Dose, Hi-Dose, Placebo).
HAM-A scores (example data):
Lo-Dose (25 mg): 21, 18, 21, 26, various other scores.
Hi-Dose (100 mg): 16, 19, 22, various scores.
Placebo: 22, 18, 29, various scores.
Dropouts: Patients without data are excluded from analysis.
Summary Statistics of Groups:
Number of groups (k): 3
Total sample size (N): 48 (after excluding dropouts).
Purpose: Compare group means to analyze variability.
Assumptions Required for One-way ANOVA:
Independent samples.
Normally distributed means.
Homogeneity of variances between groups.
Null Hypothesis (H0): No group effect; all group means are equal (µ1 = µ2 = … = µk).
Alternative Hypothesis (H1): At least one group mean is different.
F-Test Statistic: Approximated by F-distribution (F ~ F(k-1, n-k)).
MSW: Mean Square Within-group, also referred to as Mean Square Error (MSE).
MSB: Mean Square Between-group.
One-way ANOVA Steps:
Calculate MSW and MSB.
Determine F-statistic.
Goal: Analyze variability between and within groups to assess significant differences.
If the p-value from ANOVA is less than significance level (typically 0.05), reject null hypothesis. Further multiple comparison tests are needed to identify specific group differences.
Pairwise t-tests: Simple method for comparing group means but can inflate Type I error rate.
Bonferroni Adjustment: Control overall error rate when performing multiple tests by adjusting significance level to α/c.
Alternative Methods for Multiple Comparisons:
Tukey’s HSD: Less conservative, allows for all pairwise comparisons.
Dunnett’s Method: Specific comparisons against a control group.
Scheffe’s Method: More flexible but stringent in critical values.
Lo-dose and high-dose groups showed significantly lower HAM-A scores compared to placebo, reinforcing the efficiency of SN-X95 in treating anxiety symptoms.
Focus on the study of the new serotonin-uptake inhibiting agent, SN-X95 in patients with General Anxiety Disorder (GAD).
Subjects: 52 subjects diagnosed with GAD.
Groups: Randomly assigned to one of three treatment groups:
25 mg SN-X95 (Lo-Dose)
100 mg SN-X95 (Hi-Dose)
Placebo
Duration: 10 weeks of daily oral dosing, double-blind study.
Measurement Tool: Hamilton Rating Scale for Anxiety (HAM-A), scoring from 0 to 56 (higher indicates more anxiety).
Random Variable: The HAM-A scores.
Variable Type: Continuous variable.
Parameter of Interest: Mean HAM-A test scores.
Groups for Comparison: Three groups (Lo-Dose, Hi-Dose, Placebo).
HAM-A scores (example data):
Lo-Dose (25 mg): 21, 18, 21, 26, various other scores.
Hi-Dose (100 mg): 16, 19, 22, various scores.
Placebo: 22, 18, 29, various scores.
Dropouts: Patients without data are excluded from analysis.
Summary Statistics of Groups:
Number of groups (k): 3
Total sample size (N): 48 (after excluding dropouts).
Purpose: Compare group means to analyze variability.
Assumptions Required for One-way ANOVA:
Independent samples.
Normally distributed means.
Homogeneity of variances between groups.
Null Hypothesis (H0): No group effect; all group means are equal (µ1 = µ2 = … = µk).
Alternative Hypothesis (H1): At least one group mean is different.
F-Test Statistic: Approximated by F-distribution (F ~ F(k-1, n-k)).
MSW: Mean Square Within-group, also referred to as Mean Square Error (MSE).
MSB: Mean Square Between-group.
One-way ANOVA Steps:
Calculate MSW and MSB.
Determine F-statistic.
Goal: Analyze variability between and within groups to assess significant differences.
If the p-value from ANOVA is less than significance level (typically 0.05), reject null hypothesis. Further multiple comparison tests are needed to identify specific group differences.
Pairwise t-tests: Simple method for comparing group means but can inflate Type I error rate.
Bonferroni Adjustment: Control overall error rate when performing multiple tests by adjusting significance level to α/c.
Alternative Methods for Multiple Comparisons:
Tukey’s HSD: Less conservative, allows for all pairwise comparisons.
Dunnett’s Method: Specific comparisons against a control group.
Scheffe’s Method: More flexible but stringent in critical values.
Lo-dose and high-dose groups showed significantly lower HAM-A scores compared to placebo, reinforcing the efficiency of SN-X95 in treating anxiety symptoms.