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Early Prediction of Fluoxetine Response

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
fluoxetine
Sponsored by
Kaohsiung Kai-Suan Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring major depressive disorder, fluoxetine, Hamilton Rating Scale for Depression (HAM-D-17)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kai-Suan Psychiatric Hospital

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

fluoxetine

Arm Description

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2010
Last Updated
February 24, 2010
Sponsor
Kaohsiung Kai-Suan Psychiatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01075529
Brief Title
Early Prediction of Fluoxetine Response
Official Title
Model for Early Prediction of Clinical Response in Patients With Major Depression Receiving Fluoxetine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kaohsiung Kai-Suan Psychiatric Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
major depressive disorder, fluoxetine, Hamilton Rating Scale for Depression (HAM-D-17)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fluoxetine
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
fluoxetine
Intervention Description
fluoxetine 20 mg/d
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed
Time Frame
6 weeks after initiation of fluxetine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Hua Lin, M.D.
Organizational Affiliation
Kai-Suan Psychiatric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kai-Suan Psychiatric Hospital
City
Kaohsiung
ZIP/Postal Code
802
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
7868846
Citation
Tollefson GD, Holman SL. How long to onset of antidepressant action: a meta-analysis of patients treated with fluoxetine or placebo. Int Clin Psychopharmacol. 1994 Winter;9(4):245-50. doi: 10.1097/00004850-199400940-00003.
Results Reference
result
PubMed Identifier
11806859
Citation
Bech P. Meta-analysis of placebo-controlled trials with mirtazapine using the core items of the Hamilton Depression Scale as evidence of a pure antidepressive effect in the short-term treatment of major depression. Int J Neuropsychopharmacol. 2001 Dec;4(4):337-45. doi: 10.1017/S1461145701002565.
Results Reference
result
PubMed Identifier
14627997
Citation
Katz MM, Tekell JL, Bowden CL, Brannan S, Houston JP, Berman N, Frazer A. Onset and early behavioral effects of pharmacologically different antidepressants and placebo in depression. Neuropsychopharmacology. 2004 Mar;29(3):566-79. doi: 10.1038/sj.npp.1300341.
Results Reference
result
PubMed Identifier
15729083
Citation
Farabaugh A, Mischoulon D, Fava M, Wu SL, Mascarini A, Tossani E, Alpert JE. The relationship between early changes in the HAMD-17 anxiety/somatization factor items and treatment outcome among depressed outpatients. Int Clin Psychopharmacol. 2005 Mar;20(2):87-91. doi: 10.1097/00004850-200503000-00004.
Results Reference
result
PubMed Identifier
16086624
Citation
Trivedi MH, Morris DW, Grannemann BD, Mahadi S. Symptom clusters as predictors of late response to antidepressant treatment. J Clin Psychiatry. 2005 Aug;66(8):1064-70. doi: 10.4088/jcp.v66n0816.
Results Reference
result
PubMed Identifier
28841824
Citation
Yang WC, Lin CH, Wang FC, Lu MJ. Factors related to the improvement in quality of life for depressed inpatients treated with fluoxetine. BMC Psychiatry. 2017 Aug 25;17(1):309. doi: 10.1186/s12888-017-1471-3.
Results Reference
derived

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Early Prediction of Fluoxetine Response

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