This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Early Prediction of Fluoxetine Response

This study has been completed.
Information provided by:
Kaohsiung Kai-Suan Psychiatric Hospital Identifier:
First received: February 24, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
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.

Condition Intervention Phase
Major Depressive Disorder Drug: fluoxetine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Model for Early Prediction of Clinical Response in Patients With Major Depression Receiving Fluoxetine

Resource links provided by NLM:

Further study details as provided by Kaohsiung Kai-Suan Psychiatric Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed [ Time Frame: 6 weeks after initiation of fluxetine ]

Enrollment: 140
Study Start Date: March 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: fluoxetine Drug: fluoxetine
fluoxetine 20 mg/d

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01075529

Kai-Suan Psychiatric Hospital
Kaohsiung, Taiwan, 802
Sponsors and Collaborators
Kaohsiung Kai-Suan Psychiatric Hospital
Principal Investigator: Ching-Hua Lin, M.D. Kai-Suan Psychiatric Hospital
  More Information

Responsible Party: Ching-Hua Lin, M.D., Kaohsiung Kai-Suan Psychiatric Hospital Identifier: NCT01075529     History of Changes
Other Study ID Numbers: KSPH-2007-16
Study First Received: February 24, 2010
Last Updated: February 24, 2010

Keywords provided by Kaohsiung Kai-Suan Psychiatric Hospital:
major depressive disorder, fluoxetine, Hamilton Rating Scale for Depression (HAM-D-17)

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on August 18, 2017