NCT01075529

Early Prediction of Fluoxetine Response

Model for Early Prediction of Clinical Response in Patients With Major Depression Receiving Fluoxetine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Kaohsiung Kai-Suan Psychiatric Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify what degree of symptom changes during the early weeks could be used to predict eventual nonresponse at week 6 among depressive inpatients taking fluoxetine.

Detailed description

Patients with major depressive disorder will receive 20 mg/day of fluoxetine for six weeks. Symptom severity was assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at weeks 0, 1, 2, 3, 4 and 6. Stable response is defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment. Receiver operating characteristic curve will be used to determine the cutoff point of the percentage of HAMD-17 score reduction between stable responders and nonresponders at weeks 1, 2, 3 and 4.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	fluoxetine	fluoxetine 20 mg/d

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2010-02-25
• Last updated: 2010-02-25

Locations

1 site across 1 country: Taiwan