Major Depressive Disorder Clinical Trial
Official title:
Treatment of Depression Concurrent With Alcohol Abuse, an Extension of Alcohol Use Disorder in Patients Treated for Depression
The purpose of this study is to determine if having an alcohol use disorder affects recovery from depression, and also whether recovery from depression in patients who have alcohol use disorders is also accompanied by improvement in the alcohol use disorder.
This is an extension of the multi-site sub-study of the National Institute of Mental Health
(NIMH) protocol, Sequenced Treatment Alternatives to Relieve Depression (STAR*D), which
utilized the infrastructure of the Depression Trials Network to enroll 4,000 subjects
diagnosed with Major Depressive Disorder. These subjects initially received 12 weeks of
treatment with the anti-depressant citalopram. The thrust of this study was to test
treatment algorithms for those subjects who did not respond adequately to initial
monotherapy treatment with citalopram or who were unable to tolerate it. The parent protocol
also contained several ancillary studies, including a sub-study of subjects with co-morbid
alcohol use disorders, which enrolled 130 subjects. Treatment response data was collected at
multiple intervals during the 12 week treatment period on depressed subjects both with and
without a co-morbid alcohol use disorder.
Comparison: Treatment outcome measures of subjects diagnosed with Major Depressive Disorder
will be compared to treatment outcome measures of subjects diagnosed with Major Depressive
Disorder and an Alcohol Use Disorder following the initial 12 week citalopram treatment
period. This comparison will show whether having a co-morbid alcohol use disorder affects
recovery from depression. In addition, alcohol use data of depressed subjects who
demonstrated a positive response to anti-depressant treatment will be compared with alcohol
use data of depressed subjects who did not have positive treatment outcomes. This comparison
will show whether recovery from depression is associated with improvement in the co-morbid
alcohol use disorder.
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Observational Model: Case Control, Time Perspective: Prospective
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