Early Prediction of Fluoxetine Response
- Registration Number
- NCT01075529
- Lead Sponsor
- Kaohsiung Kai-Suan Psychiatric Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- diagnosis of major depressive disorder
- HAM-D-17 ≧17
- written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description fluoxetine fluoxetine -
- Primary Outcome Measures
Name Time Method Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment 6 weeks after initiation of fluxetine
- Secondary Outcome Measures
Name Time Method CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed 6 weeks after initiation of fluxetine
Trial Locations
- Locations (1)
Kai-Suan Psychiatric Hospital
🇨🇳Kaohsiung, Taiwan