Assessment of Augmentation Strategies to Optimize the Therapeutic Response to Mirtazapine in Major Depression

ISRCTN ISRCTN44468346
DOI https://doi.org/10.1186/ISRCTN44468346
Secondary identifying numbers N/A
Submission date
13/09/2005
Registration date
15/02/2006
Last edited
16/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Pierre Blier
Scientific

1145 Carling Avenue
LG 2043
Ottawa
ON K1Z 7K4
Canada

+1 613 722 6521/6908
pblier@rohcg.on.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study hypothesis1. 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.
Ethics approval(s)Not provided at time of registration
ConditionMajor depression
InterventionThis 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)1. Mirtazapine 2. Fluoxetine 3. Bupropion 4. Venlafaxine
Primary outcome measureThe 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 measuresThe secondary variable is the depression subscale of the Symptom Checklist-90-R (SCL-90-R)
Overall study start date01/07/2001
Overall study end date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Participant inclusion criteria1. 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
Participant exclusion criteria1. 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
Recruitment start date01/07/2001
Recruitment end date31/12/2005

Locations

Countries of recruitment

  • Canada
  • United States of America

Study participating centre

1145 Carling Avenue
Ottawa
ON K1Z 7K4
Canada

Sponsor information

Organon International Inc. (USA)
Industry

c/o John H. Simmons, M.D.
Director, Global Medical Affairs
Organon International Inc.
56 Livingston avenue
Roseland
New Jersey
07068
United States of America

ROR logo https://ror.org/02891sr49

Funders

Funder type

Industry

Organon International Inc (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2010 Yes No
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