Early Prediction of Fluoxetine Response

Major Depressive Disorder Clinical Trial

Official title:

Model for Early Prediction of Clinical Response in Patients With Major Depression Receiving Fluoxetine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075529
• Other study ID #: KSPH-2007-16
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2010
• Last updated: February 24, 2010
• Start date: March 2007
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Kaohsiung Kai-Suan Psychiatric Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• fluoxetine
fluoxetine 20 mg/d

Locations

Country	Name	City	State
Taiwan	Kai-Suan Psychiatric Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Kai-Suan Psychiatric Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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 — View 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 — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment		6 weeks after initiation of fluxetine	Yes
Secondary	CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed		6 weeks after initiation of fluxetine	Yes