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Early Prediction of Fluoxetine Response

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01075529
Enrollment
140
Registered
2010-02-25
Start date
2007-03-31
Completion date
2010-02-28
Last updated
2010-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

major depressive disorder, fluoxetine, Hamilton Rating Scale for Depression (HAM-D-17)

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.

Interventions

DRUGfluoxetine

fluoxetine 20 mg/d

Sponsors

Kaohsiung Kai-Suan Psychiatric Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment6 weeks after initiation of fluxetine

Secondary

MeasureTime frame
CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed6 weeks after initiation of fluxetine

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026