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Early Prediction of Fluoxetine Response

This study has been completed.
Sponsor:
Information provided by:
Kaohsiung Kai-Suan Psychiatric Hospital
ClinicalTrials.gov Identifier:
NCT01075529
First received: February 24, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Study First Received: February 24, 2010
Last Updated: February 24, 2010
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Fluoxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014