Early Prediction of Fluoxetine Response

Kaohsiung Kai-Suan Psychiatric Hospital

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: fluoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT01075529

KSPH-2007-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

fluoxetine

No Intervention group

Treatment:

Drug: fluoxetine