drugset / Trial / NCT04437485
eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk
Phase 2
Completed
46 enrolled
Indiana University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
This pilot randomized controlled trial seeks: (1) to determine the preliminary efficacy of our modernized collaborative care intervention for depression in improving the diabetes risk markers of hemoglobin A1c and insulin resistance and (2) to explore whether somatic depressive symptoms - i.e., hyperphagia (increased appetite/weight) and/or hypersomnia (increased sleep) - moderate the effect of the eIMPACT-DM intervention on diabetes risk markers.
Timeline
- Start
- 2020-10-14
- Primary completion
- 2022-08-29
- Completion
- 2022-08-29
Outcome
Missed primary endpoint
registry analysis (superiority test); eIMPACT-DM Intervention vs Active Control; p = 0.64; ANCOVA NCT04437485 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | — | — |
| Subject | Desvenlafaxine | Other / unclassified | — | — |
| Subject | Duloxetine | Small molecule | — | — |
| Subject | Escitalopram | Small molecule | — | — |
| Subject | Fluoxetine | Small molecule | — | — |
| Subject | Sertraline | Small molecule | — | — |
| Subject | Venlafaxine | Small molecule | — | — |