Major Depressive Disorder Clinical Trial
Official title:
Combining Medications to Enhance Depression Outcomes
This study will compare whether a combination of antidepressant medications is better than one antidepressant medication alone when given as initial treatment for people with chronic or recurrent major depressive disorder.
The overall aim of Combining Medications to Enhance Depression Outcomes (CO-MED) is to
enhance remission rates for outpatients with chronic or recurrent nonpsychotic major
depressive disorder (MDD) as defined by DSM-IV TR, treated in primary or psychiatric care
settings.
Current evidence indicates that remission, the goal of treatment, is found in only about
one-third of representative depressed outpatients treated for up to 14 weeks with an initial
SSRI. In addition, even for those who do respond or remit, over one-third relapse in the
subsequent 12 months. Combinations of antidepressants are used in practice at the second or
subsequent steps when relapse occurs in the longer term, or, in some cases, even acutely as
a first step when speed of effect is a clinical priority. Whether such combinations could
potentially offer higher remission rates, lower attrition, or greater longer-term benefit if
used as initial treatments as compared to monotherapy remains to be examined.
CO-MED will test whether two different medications when given in combination as the first
treatment step, compared to one medication, will enhance remission rates, increase speed of
remission, be tolerable, and provide better sustained benefits in the longer term. Results
of this study will inform practitioners in managing the treatment of patients with chronic
or recurrent MDD.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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