Model for Early Prediction of Clinical Response in Patients With Major Depression Receiving Fluoxetine
Overview
- Phase
- Phase 4
- Intervention
- fluoxetine
- Conditions
- Major Depressive Disorder
- Sponsor
- Kaohsiung Kai-Suan Psychiatric Hospital
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
fluoxetine
Intervention: fluoxetine
Outcomes
Primary Outcomes
Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment
Time Frame: 6 weeks after initiation of fluxetine
Secondary Outcomes
- CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed(6 weeks after initiation of fluxetine)