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Early Prediction of Fluoxetine Response

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ClinicalTrials.gov Identifier: NCT01075529
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : February 25, 2010
Sponsor:
Information provided by:

Study Description
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.

Study Design

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
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01075529


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

Publications:
Responsible Party: Ching-Hua Lin, M.D., Kaohsiung Kai-Suan Psychiatric Hospital
ClinicalTrials.gov Identifier: NCT01075529     History of Changes
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:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Fluoxetine
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