Beyond just judging safety and efficacy, STAR*D measured practical outcomes,
including, in subsequent phases of the study, how well the individual is actually
functioning — even a year later. The goal of the trial was remission. People
who become symptom-free generally function better and are less prone to relapse.
Efficacy trials normally seek only a reduction in symptoms.
?These trials match the NIMH vision of developing personalized care,? explained
NIMH Director Dr. Thomas Insel in an accompanying editorial. ?By beginning to
identify which particular treatment benefits which patient, the STAR*D trial
takes us a little closer to realizing this vision for non-psychotic depression.?
While efficacy trials typically compare a drug with placebo (inactive pill)
for only 8 weeks and exclude patients with complicating or chronic problems,
STAR*D compared several active treatments, including a psychotherapy, over much
longer periods, and welcomed a broad spectrum of patients with co-occurring drug,
alcohol and physical health disorders, or a history of suicide attempts. Instead
of recruiting volunteers through ads to research clinics, STAR*D enrolled patients
already seeking help in the 41 participating clinics nationwide.
Representative of national ethnic and socioeconomic populations, the study participants
were outpatients ages 18-75 who scored high enough on a standard depression rating
scale to be diagnosed with major depression. They included some of the most chronic
patients with depression. More than a third of the participants were under age
18 when they first experienced depression, 75 percent had at least two episodes
of depression, and for 25 percent the current episode of depression had lasted
for at least two years.
Clinicians adjusted dosages of citalopram during five to six visits at two to
three week intervals, based on a treatment manual and quick and easy-to-use symptom
ratings and patient and side-effect ratings. The researchers collected depression
ratings and other data by phone, including an automated interactive voice response
system.
?Self-rating scales are no longer just research tools,? said Rush. ?An easy-to-use
patient-rated scale proved to be as accurate as the standard depression scale,
so the time is ripe for practitioners to begin using them as part of systematic
assessments to guide routine treatment. Our results also suggest that to achieve
remission, some patients may need to stay in treatment longer and take somewhat
higher antidepressant dosages, as warranted by their individualized assessments.?
The results were corroborated by ?remarkably consistent findings? across both
standard and patient-rated depression rating scales, note the researchers. On
average, it took patients six to seven weeks of treatment to reach ?remission? of
their depressive symptoms. The average number of visits for those successfully
treated participants was between five and six, with 40 percent of participants
who eventually became symptom-free requiring eight or more weeks of treatment
(when most efficacy trials normally end). Almost all of the participants who
became symptom-free continued on their treatment for over eight weeks, many for
12 weeks.