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Completed

NCT Number: NCT01075529

Early Prediction of Fluoxetine Response

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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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kai-Suan Psychiatric Hospital

Kaohsiung City, 802, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoxetine

Drug

fluoxetine 20 mg/d

Primary outcomes

  1. Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment

    Time frame: 6 weeks after initiation of fluxetine

Secondary outcomes

  1. CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed

    Time frame: 6 weeks after initiation of fluxetine

Sponsors and collaborators

Lead sponsor

Kaohsiung Kai-Suan Psychiatric Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 25, 2010
Registry last updated
Feb 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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