Major Depressive Disorder Clinical Trial
Official title:
Model for Early Prediction of Clinical Response in Patients With Major Depression Receiving Fluoxetine
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 |
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.
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Kai-Suan Psychiatric Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Kaohsiung Kai-Suan Psychiatric Hospital |
Taiwan,
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
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 |
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