Initial results of the nation?s largest clinical trial for depression have
helped clinicians to track ?real world? patients who became symptom-free and
to identify those who were resistant to the initial treatment. Participants treated
in both medical and specialty mental health care settings experienced a remission
of symptoms in 12 to 14 weeks during well-monitored treatment with an antidepressant
medication. The study, funded by the National Institutes of Health?s (NIH) National
Institute of Mental Health (NIMH), used flexible adjustment of dosages based
on quick and easy-to-use clinician ratings of symptoms and patient self-ratings
of side effects.
About a third of participants reached a remission or virtual absence of symptoms
during the initial phase of the study, with an additional 10 to 15 percent experiencing
some improvement. Subsequent phases of the trials will help determine successful
treatments for the nearly two thirds of those patients who were identified as
treatment-resistant to a first medication in phase one.
The trial, known as the STAR*D study — Sequenced Treatment Alternatives
to Relieve Depression — included 2,876 participants and was conducted over
six years at a cost of $35 million. (For more information on STAR*D, go to: http://www.clinicaltrials.gov/ct/show/NCT00021528?order=1).
The medication used in this first phase of the study was the serotonin reuptake
inhibitor (SSRI) citalopram (Celexa, made by Forest Pharmaceuticals), and response
rates were comparable across the 23 psychiatric and 18 primary care treatment
sites. John Rush, M.D., and Madhukar Trivedi, M.D., of the University of Texas
Southwestern Medical Center (UTSMC), and colleagues report on the results of
phase 1 of STAR*D in the January, 2005 American Journal of Psychiatry.
?The real goal of STAR*D is how best to help the 70 percent of patients for
whom treatment with a representative SSRI is not enough for remission,? said
NIMH Director Thomas Insel, M.D. ?As the results of subsequent levels of the
trial are revealed in the coming months, we will learn the effectiveness of other
treatment options.?
In the first phase of STAR*D, being well-educated, employed, married, white
and female, with few complicating problems, were factors associated with a better
antidepressant response. Factors associated with a poorer response included co-occurring
anxiety, substance abuse or physical disorders, and lower quality of life.
This study is an effectiveness trial, which typically asks tougher questions
than traditional efficacy trials, which measure only the reduction of symptoms.
Effectiveness trials, which measure symptom reduction and patient function, also
take into account the often untidy realities clinicians face. For example, if
a patient is not responding adequately to an initial medication in 4 or 6 weeks,
what is the next best treatment option?