antidepressant_data {rbmi}

Antidepressant trial data

Description

A dataset containing data from a publicly available example data set from an antidepressant clinical trial. The dataset is available on the website of the Drug Information Association Scientific Working Group on Estimands and Missing Data. As per that website, the original data are from an antidepressant clinical trial with four treatments; two doses of an experimental medication, a positive control, and placebo and was published in Goldstein et al (2004). To mask the real data, week 8 observations were removed and two arms were created: the original placebo arm and a "drug arm" created by randomly selecting patients from the three non-placebo arms.

Usage

antidepressant_data

Format

A data.frame with 608 rows and 11 variables:

• PATIENT: patients IDs.

• HAMATOTL: total score Hamilton Anxiety Rating Scale.

• PGIIMP: patient's Global Impression of Improvement Rating Scale.

• RELDAYS: number of days between visit and baseline.

• VISIT: post-baseline visit. Has levels 4,5,6,7.

• THERAPY: the treatment group variable. It is equal to PLACEBO for observations from the placebo arm, or DRUG for observations from the active arm.

• GENDER: patient's gender.

• POOLINV: pooled investigator.

• BASVAL: baseline outcome value.

• HAMDTL17: Hamilton 17-item rating scale value.

• CHANGE: change from baseline in the Hamilton 17-item rating scale.

Details

The relevant endpoint is the Hamilton 17-item rating scale for depression (HAMD17) for which baseline and weeks 1, 2, 4, and 6 assessments are included. Study drug discontinuation occurred in 24% subjects from the active drug and 26% from placebo. All data after study drug discontinuation are missing and there is a single additional intermittent missing observation.

References

Goldstein, Lu, Detke, Wiltse, Mallinckrodt, Demitrack. Duloxetine in the treatment of depression: a double-blind placebo-controlled comparison with paroxetine. J Clin Psychopharmacol 2004;24: 389-399.