Early Prediction of Fluoxetine Response

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 802
    • Kai-Suan Psychiatric Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: fluoxetine	Drug: fluoxetine; fluoxetine 20 mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed	6 weeks after initiation of fluxetine

Collaborators and Investigators

• Sponsor: Kaohsiung Kai-Suan Psychiatric Hospital
• Investigators: Principal Investigator: Ching-Hua Lin, M.D., Kai-Suan Psychiatric Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: February 24, 2010
• First Submitted That Met QC Criteria: February 24, 2010
• First Posted (Estimate): February 25, 2010

Study Record Updates

• Last Update Posted (Estimate): February 25, 2010
• Last Update Submitted That Met QC Criteria: February 24, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: major depressive disorder, fluoxetine, Hamilton Rating Scale for Depression (HAM-D-17)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: KSPH-2007-16