Early Prediction of Fluoxetine Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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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

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Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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fluoxetine

Group Type NO_INTERVENTION

fluoxetine

Intervention Type DRUG

fluoxetine 20 mg/d

Interventions

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fluoxetine

fluoxetine 20 mg/d

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No