Clinical trial NCT01075529: Early Prediction of Fluoxetine Response
Official title: Model for Early Prediction of Clinical Response in Patients With Major Depression Receiving Fluoxetine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: major depressive disorder, fluoxetine, Hamilton Rating Scale for Depression (HAM-D-17)
Lead sponsor: Kaohsiung Kai-Suan Psychiatric Hospital
Sponsor class: OTHER_GOV
First posted: 2010-02-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment
timeFrame: 6 weeks after initiation of fluxetine
Secondary outcomes:
measure: CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed
timeFrame: 6 weeks after initiation of fluxetine
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kai-Suan Psychiatric Hospital
Study officials:
affiliation: Kai-Suan Psychiatric Hospital
name: Ching-Hua Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.