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Assessment of Augmentation Strategies to Optimize the Therapeutic Response to Mirtazapine in Major Depression
ISRCTN ISRCTN44468346
DOI 10.1186/ISRCTN44468346
ClinicalTrials.gov identifier
EudraCT number
Public title Assessment of Augmentation Strategies to Optimize the Therapeutic Response to Mirtazapine in Major Depression
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis 1. A six-week treatment with a daily dose 20 mg of fluoxetine by itself will produce a clinically significant antidepressant response
2. A six-week treatment with mirtazapine in combination with any of the following three antidepressant medications: fluoxetine, bupropion, or venlafaxine, by producing a sustained increase in 5-hydroxytryptamine (5-HT) synaptic availability in the presence of epinephrine (NE) reuptake blockade or increased NE release, will induce a more robust clinical response compared to those patients receiving only fluoxetine
3. A six-week treatment with a combination of mirtazapine and venlafaxine or with mirtazapine and bupropion, by producing initially a greater synaptic availability of NE than with mirtazapine alone, and by enhancing 5-HT neurotransmission rapidly as well, will induce a more rapid clinical response. Therefore, patients receiving a six-week treatment with these two combinations of antidepressant medications will demonstrate an earlier onset of their clinical response compared to those receiving only fluoxetine or fluoxetine plus mirtazapine.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United States of America
Disease/condition/study domain Major depression
Participants - inclusion criteria 1. Male or female patients between 18 and 65 years of age
2. Diagnosis of major depression according to the Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) (American Psychiatric Association, 1994) using the Structural Clinical Interview for DSM-IV (SCID) (Spitzer and Williams, 1988)
3. Initial global score 18 on the first 17 items of the 24-item Hamilton Depression Rating Scale
4. Written informed consent signed by the patient
Participants - exclusion criteria 1. Patients who have not participated in another clinical trial in the past 30 days
2. Evidence of suicidal tendencies
3. Evidence of significant physical illness contraindicating the use of fluoxetine, mirtazapine, venlafaxine or bupropion, found on physical or in the laboratory data obtained during the first week of the study
4. Mental retardation (Intelligence Quotient [IQ] lower than 80) rendering the response to investigators unreliable
5. Pregnancy, or absence of adequate contraceptive method in women with childbearing potential
6. Concurrent use of psychotropic medication such as neuroleptics, mood stabilizers or regular use of high doses of benzodiazepines
7. Lack of response to fluoxetine for the present episode
Anticipated start date 01/07/2001
Anticipated end date 31/12/2005
Status of trial Completed
Patient information material
Target number of participants 100
Interventions This is a double-blind study comparing the effects of fluoxetine alone to those of mirtazapine plus fluoxetine, mirtazapine plus venlafaxine, and mirtazapine plus bupropion in patients presenting with major depression. At the end of the six-week trial, remitters that received either fluoxetine plus placebo or fluoxetine plus mirtazapine will be maintained on fluoxetine alone for six months and those that received either bupropion or venlafaxine will be maintained on mirtazapine alone for the same period of prolongation. Non-responders will be offered alternate treatment strategies by the principal investigator.
Primary outcome measure(s) The primary efficacy variables are the total Hamilton Depression Rating Scale (HAM-D), total Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression (CGI) improvement scale, CGI severity scale, the percentage of responders (i.e. improvement of 50% or more on the total MADRS), and the percentage of remitters (i.e. a score of 8 or less on the HAM-D)
Secondary outcome measure(s) The secondary variable is the depression subscale of the Symptom Checklist-90-R (SCL-90-R)
Sources of funding Organon International Inc (USA)
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20008946
Contact name Prof  Pierre  Blier
  Address 1145 Carling Avenue
LG 2043
  City/town Ottawa
  Zip/Postcode ON K1Z 7K4
  Country Canada
  Tel +1 613 722 6521/6908
  Fax +1 613 792 3935
  Email pblier@rohcg.on.ca
Sponsor Organon International Inc. (USA)
  Address c/o John H. Simmons, M.D.
Director, Global Medical Affairs
Organon International Inc.
56 Livingston avenue
Roseland
  City/town New Jersey
  Zip/Postcode 07068
  Country United States of America
Date applied 13/09/2005
Last edited 16/08/2011
Date ISRCTN assigned 15/02/2006
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