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Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon — TAKEDA  

Major Depressive Disorder Clinical Trial

Official title:
Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon

Clinical Trial 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.

Clinical Trial Description

The primary objective of the study is to assess the time to remission in depression with initial insomnia using the SSRI antidepressant escitalopram combined with ramelteon or placebo. Patients will be assessed at each visit for depressive symptoms and insomnia, using the 30-item Inventory of Depressive Symptoms, Clinician-Rated version (IDS-C30; Rush et al 1986; Rush et al., 1996) as the primary outcome measure. The IDS self-report version will be used to assess self-reported changes in symptom severity. The 17 item Hamilton Rating Scale for Depression, (HRSD17; Hamilton, 1960) will also be administered, as it is the most commonly utilized depression symptom severity measure at this time. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00642694
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Terminated
Phase Phase 3
Start date May 2007
Completion date May 2010
View Details
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