drugset / Trial / NCT00642694
Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon
Phase 3
Terminated
29 enrolled
University of Texas Southwestern Medical Center
Takeda Pharmaceuticals North America, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Hypothesis I: Patients in the SSRI + ramelteon treatment group will achieve remission (defined as an IDS-C30 score of 11 or less) more quickly than those in the SSRI + placebo group.
Timeline
- Start
- 2007-05
- Primary completion
- 2010-05
- Completion
- 2010-05
Outcome
Missed primary endpoint
Stopped (Enrollment): “Enrollment discontinued based on mutually agreed upon decision by PI and funding sponsor”
registry analysis (superiority test); Escitalopram + Ramelteon vs Escitalopram + Placebo; p = 0.05; Mixed Models Analysis NCT00642694 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ramelteon | Unknown | 8 mg | — |
| Background | Escitalopram | Small molecule | 10 mg | — |
| Background | Escitalopram | Small molecule | 20 mg | — |