Condition category
Mental and Behavioural Disorders
Date applied
13/09/2005
Date assigned
15/02/2006
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Pierre Blier

ORCID ID

Contact details

1145 Carling Avenue
LG 2043
Ottawa
ON K1Z 7K4
Canada
+1 613 722 6521/6908
pblier@rohcg.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Major depression

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

1. Mirtazapine
2. Fluoxetine
3. Bupropion
4. Venlafaxine

Primary outcome measures

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 measures

The secondary variable is the depression subscale of the Symptom Checklist-90-R (SCL-90-R)

Overall trial start date

01/07/2001

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/07/2001

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United States of America

Trial participating centre

1145 Carling Avenue
Ottawa
ON K1Z 7K4
Canada

Sponsor information

Organisation

Organon International Inc. (USA)

Sponsor details

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

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Organon International Inc (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20008946

Publication citations

  1. Results

    Blier P, Ward HE, Tremblay P, Laberge L, Hébert C, Bergeron R, Combination of antidepressant medications from treatment initiation for major depressive disorder: a double-blind randomized study., Am J Psychiatry, 2010, 167, 3, 281-288, doi: 10.1176/appi.ajp.2009.09020186.

Additional files

Editorial Notes