Early Prediction of Fluoxetine Response
Information source: Kaohsiung Kai-Suan Psychiatric Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: fluoxetine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Kaohsiung Kai-Suan Psychiatric Hospital Official(s) and/or principal investigator(s): Ching-Hua Lin, M.D., Principal Investigator, Affiliation: Kai-Suan Psychiatric Hospital
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.
Clinical Details
Official title: Model for Early Prediction of Clinical Response in Patients With Major Depression Receiving Fluoxetine
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment
Secondary outcome: CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Kai-Suan Psychiatric Hospital, Kaohsiung 802, Taiwan
Additional Information
Starting date: March 2007
Last updated: February 24, 2010
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