Depressed Teens Helped with Combination Drug and Talk Therapy
CLEVELAND -- A short-term
approach, involving both medication and specific cognitive behavioral
'talk' therapy, is highly effective in the treatment of teenage
depression. In a national
study involving more than 400 adolescents (including 33 from the
Cleveland area), researchers concluded that a combination of Prozac and
focused psychotherapy, known as CBT, appears to be the best approach to
both alleviating depression and reducing the level of suicidal thinking
in adolescents.
The findings result from stage one of the "Treatment for Adolescents with Depression Study"
(TADS). The federally funded study is the first multicenter, randomized
clinical trial to examine the individual and combined effectiveness of
the antidepressant fluoxetine (trade name Prozac) and CBT in
adolescents diagnosed with mild to severe depression. The results
appeared in the Aug. 18, 2004 issue of the Journal of the American Medical Association.
The study team found that fluoxetine plus CBT offered greater
effectiveness in treatment than the drug alone. The CBT used in this
study is a depression-specific psychotherapeutic treatment designed to
create and reinforce positive thought patterns and behavior in the
adolescents, said the researchers. Contrary to expectations, CBT alone offered no greater effectiveness than placebo, they found.
"What it is saying to us is that the delivery of fluoxetine in a
supportive, consistent medication management milieu is quite helpful,
but that you can bolster the efficacy of medication when you add a
specific talk therapy," says Norah Feeny, PhD,
adolescent psychologist at University Hospitals of Cleveland and
assistant professor at Case Western Reserve University School of
Medicine. "Teenagers can learn specific skills that they can then
utilize in conjunction with taking medication: to learn to bolster
their moods, to solve problems. So, the combination of both
talking and taking medication, maybe they have a synergistic effect."
The researchers emphasized that their findings regarding the safety
issues of the therapies -- specifically protection against the
potential danger of suicide -- are complex. Their results show that
suicidal thinking decreased among all treatment groups, with the
greatest reduction occurring in the group receiving combination
therapy. Although fluoxetine alone did not increase suicidal thoughts,
it did seem to increase the risk for harm-related behaviors. This
effect, however, seemed to be buffered by concomitant CBT. The
complexity will add to the considerable debate about the use of SSRIs
and the link to suicide in adolescents, according to the lead author.
"Depression constitutes a significant public health problem among
adolescents, and there has been a tremendous need for identifying
effective treatments that are also deemed safe," said John March, M.D.,
chief of child and adolescent psychiatry at Duke University and lead
investigator on the study. "Children and young adults suffer serious
impairments from depression, especially if they remain undiagnosed.
Depression is very common, but those affected must be identified and
referred for treatment.
"While fluoxetine proved to be an effective treatment, after weighing
the risks and benefits I would strongly encourage the use of
combination therapy as the best treatment for depressed teenagers."
The randomized, controlled clinical trial enrolled 439 patients between
the ages of 12 and 17 with a primary diagnosis of major depressive
disorder. None of the patients were taking antidepressants before
beginning study treatment and all could be cared for on an outpatient
basis. To be considered for the trial, the patients must have
experienced a depressive mood in at least two of three areas (home,
school or among peers) for at least six weeks prior to the study.
Adolescents with other severe behavioral or mental disorders, a history
of endangering themselves or others, or dealing with drug abuse or
addictions were excluded from the study.
The three-year enrollment took place at 13 academic and community
clinics. Patients were randomized into one of four groups for a 12-week
treatment period. One group received treatment with fluoxetine alone
(10 to 40 milligrams per day); one group received CBT alone (15
one-hour treatment sessions); one group received a combination of
fluoxetine (at the dosage above) with CBT; and the final group received
placebo alone (placebo pills identical in appearance to those
containing fluoxetine). Fluoxetine and placebo were both administered
in a double-blind fashion; the CBT alone and CBT with fluoxetine groups
were unblinded.
Compared with fluoxetine and CBT alone, the combination therapy proved
superior with a 71 percent response rate. Compared to placebo,
fluoxetine worked very well with a 60.6 percent response rate. However,
CBT alone (43.2 percent response) proved to be not much more effective
than placebo (34.8 percent response). Clinically significant suicidal
"ideation," meaning suicidal thinking or imaginings, had been present
in 29 percent of the study participants at the beginning of the study.
By study completion, the level of suicidal ideation improved
significantly in all treatment groups. The team found that fluoxetine
coupled with CBT offered the greatest reduction in suicidal thoughts.
There were seven cases of attempted suicide but no completed suicides.
"Our data show that suicidal thinking gets better with all forms of
treatment used in this trial," March said. "Harm-related behaviors
occurred at a very low rate among our participants. While harm-related
behaviors might be slightly more likely to occur in teens taking the
antidepressant, CBT reduces harm-related behaviors to such an extent
that the benefits of CBT outweigh the risks associated with the
medication. We think this may be one of the reasons why the combination
therapy proved to be more effective."
According to the researchers, MDD is common, with one in 20 teens
affected at varying levels of severity. Like other forms of depression,
MDD has been associated with increased risk of suicidal behavior and
with completed suicide. It has also been linked to long-term
psychosocial impairment in adulthood. In the United States, 500,000
adolescents attempt suicide every year and 2,000 die as the result of
their injuries. According to 2001 statistics from the National Center for Injury Prevention and Control, suicide is the third leading cause of death in Americans aged 10 to 24.
The research was funded by the National Institute of Mental Health, a division of the National Institutes of Health.
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Posted on Tuesday, August 17, 2004 (Archive on Tuesday, August 24, 2004) |
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