Trial | NCT01075529  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluoxetine ...

  • Study Participants

    140
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.
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.
Study Started
Mar 31
2007
Primary Completion
Feb 28
2010
Study Completion
Feb 28
2010
Last Update
Feb 25
2010
Estimate

Drug fluoxetine

fluoxetine 20 mg/d

fluoxetine No Intervention

Criteria 

Inclusion Criteria:

diagnosis of major depressive disorder
HAM-D-17 ≧17
written informed consent

Exclusion Criteria:

Comorbid of substance abuse/dependence
Comorbid with mental disorders due to general medical conditions
Past history of treatment-resistant depression
Severe physical problems
pregnant women
lactation
No Results Posted