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Early Prediction of Fluoxetine Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01075529
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : February 25, 2010
Information provided by:
Kaohsiung Kai-Suan Psychiatric Hospital

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: fluoxetine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
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
Study Start Date : March 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
No Intervention: fluoxetine Drug: fluoxetine
fluoxetine 20 mg/d

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01075529

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Kai-Suan Psychiatric Hospital
Kaohsiung, Taiwan, 802
Sponsors and Collaborators
Kaohsiung Kai-Suan Psychiatric Hospital
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Principal Investigator: Ching-Hua Lin, M.D. Kai-Suan Psychiatric Hospital
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ching-Hua Lin, M.D., Kaohsiung Kai-Suan Psychiatric Hospital Identifier: NCT01075529    
Other Study ID Numbers: KSPH-2007-16
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: February 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:
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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