Paroxetine and Imipramine Adolescent Depression Trial Data

275 adolescents with major depression were randomized to paroxetine, imipramine, or placebo across 12 North American centers from 1994 to 1998. This reanalysis under the RIAT initiative found no statistically significant efficacy for either drug compared to placebo and noted increases in specific harms. The dataset provides primary clinical trial data for re-evaluating evidence-based medicine conclusions.

Use Cases

• Compare change in Hamilton depression scale (HAM-D) scores between paroxetine, imipramine, and placebo groups to reassess drug efficacy.
• Analyze the proportion of responders (HAM-D score ≤8) across treatment arms to evaluate clinical significance.
• Investigate adverse event rates, including suicidal ideation and cardiovascular problems, by drug treatment group.
• Examine secondary outcomes like changes in K-SADS-L depression items or clinical global impression scores.

Strengths

• Data originates from a double-blind, randomized, placebo-controlled trial, the gold standard for clinical evidence.
• Dataset covers 275 adolescent participants across 12 academic psychiatry centers, providing a multi-site sample.
• Reanalysis was conducted under the RIAT initiative with full access to the primary trial dataset, enhancing transparency.

Limitations

• The original trial ran from 1994 to 1998, making the data over two decades old and potentially less reflective of current patient populations or practices.
• Exclusion criteria included a range of comorbid disorders and suicidality, limiting generalizability to adolescents with more complex presentations.
• No prespecified coding dictionary for adverse experiences was used, which may complicate standardized harm comparisons.

Provenance

Source

Reanalysis of SmithKline Beecham's Study 329, published by Keller et al. in 2001.

Collection Method

Double-blind randomized placebo-controlled trial.

Time Range

20 April 1994 to 15 February 1998.

Freshness

Last updated in 2020, representing a reanalysis of historical trial data.

Geography

12 North American academic psychiatry centers.