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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

Page last updated: August 23, 2015

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