ricevuto da Andrea Ventura
dopo numerosi casi di suicidii di giovani e giovanissimi che subivano la terapia e dopo l'allarme lanciato in proposito persino dalla Food and Drug Administration, una ricerca, finanziata dal governo degli Stati Uniti con 17 milioni di dollari, sostiene che il Prozac è molto più efficace dei trattamenti psicologici per battere la depressione nei bambini e negli adolescenti.
il 3 giugno scorso a questa stessa ricerca aveva fatto riferimento un articolo del Corriere della Sera che era stato riportato anche su questo blog: lo inseriamo di nuovo qui di seguito
New York Times Published: June 2, 2004
Antidepressant Seen as Effective in Treatment of Adolescents
A government-financed study has found that Prozac helps
teenagers overcome depression far better than talk therapy.
By GARDINER HARRIS
PHOENIX, June 1 — In the midst of a worldwide debate on whether depressed children should be treated with antidepressant drugs like Prozac, a landmark government-financed study has found that Prozac helps teenagers overcome depression far better than talk therapy. But a combination of the two treatments, the study found, produced the best result.
The study, sponsored by the National Institute of Mental Health, was the first to compare psychotherapy and drug treatment for depressed adolescents. Statistically, the researchers found, talk therapy — in which a patient discusses problems with a therapist — was by itself no more effective in reducing the depression than treatment with placebos. But when combined with drug treatment, psychotherapy appeared to provide added benefit and to reduce the risk of suicide.
The findings are likely to reassure psychiatrists, pediatricians and others who increasingly prescribe antidepressants to teenagers and children. Millions of young people take the drugs.
Experts said that the study was notable for its size and for the fact that it was carried out without financing by drug manufacturers. Data on the effects of antidepressants in adolescents is in short supply. Most studies of the question have been small trials sponsored by pharmaceutical companies and have failed to show that the drugs are effective for depressed teenagers.
"This study should put to rest doubts about whether these drugs work in teenagers with severe depression," said Dr. Graham Emslie, a professor of psychiatry at the University of Texas Southwestern Medical Center and an author of the study, which was presented here on Tuesday at a meeting of psychiatric drug researchers.
Still, the findings are unlikely to resolve the controversy over whether Prozac and similar drugs lead a small number of teenagers and children to become suicidal.
Such concerns led the Food and Drug Administration to warn earlier this year that patients taking the drugs should be watched closely for signs of suicide or other harmful behavior in the first weeks of therapy. The agency is reanalyzing suicidal events that occurred during drug-company trials of antidepressants in children and teenagers. British drug regulators have banned the use of all but Prozac in those younger than 18.
The government study, called the Treatment for Adolescents with Depression Study, involved 439 youths ages 12 to 17 who were suffering from moderate to severe depression.
The adolescents were randomly assigned to be treated for a period of 36 weeks with either Prozac, the antidepressant drug made by Eli Lilly & Company; a form of talk therapy known as cognitive behavioral therapy; placebo pills; or a combination of Prozac and talk therapy.
The researchers collected data on the subjects for a year, but have only analyzed information from the first 12 weeks so far. Of the youths recruited for the study, 378 completed the first 12 weeks of treatment. Their mean age was 15. Depression levels were measured using several common psychological scales.
Using one measurement scale, the researchers found that after 12 weeks, 71 percent of the subjects who received Prozac and talk therapy responded well to treatment, compared with 61 percent of those who received Prozac alone, 43 percent of who received talk therapy alone and 35 percent of those who received a placebo treatment. By another measure, talk therapy alone fared no better than treatment with placebos.
The researchers also found that patients became significantly less suicidal, no matter which treatment they were given. No patient committed suicide during the trial. But the risk of a suicide attempt among the patients given Prozac was twice that of those who did not, the study found. There were five suicide attempts among those given Prozac and just one among other participants.
Dr. John March, a professor of psychiatry at Duke University and the study's lead investigator, said that the findings showed Prozac's benefits for depressed teenagers and children far outweighed its risks. "The take-home message is that these adverse events are extremely rare,'' he said.
Dr. March acknowledged, however, that the controversy about suicide and antidepressant therapy was far from resolved. "We're all holding our breath to see what the F.D.A. is going to do,'' he said.
Psychologists, who are often the providers of talk therapy and who cannot prescribe drugs, are likely to be disappointed in the finding that cognitive behavioral therapy was found to be little better than a sugar pill. A recent major trial comparing drugs with talk therapy in children with attention-deficit disorder also showed that the drugs worked better.
But the findings of another study presented on Tuesday suggest that for some conditions, talk therapy may be more effective than antidepressants. That study compared cognitive behavioral therapy with Zoloft, an antidepressant similar to Prozac that is made by Pfizer, in teenagers who suffered from obsessive compulsive disorder. Those who received the talk therapy, the study found, improved more than those who were treated with the drug.
Dr. Thomas Insel, director of the National Institute of Mental Health, said he was pleased the results of the depression study were so clear. The institute spent $17 million over six years financing the trial. "The most striking thing about the study is that, in all groups, there was a dramatic decrease in the amount of suicidal thinking,'' he said, suggesting that all the therapies were protective.
Dr. David Brent, a professor of psychiatry at the University of Pittsburgh not involved with the study, suggested that another form of talk therapy called interpersonal therapy might have fared better than cognitive behavioral therapy.
In interpersonal therapy, clinicians focus on a patient's relationships with peers and family members and the way they see themselves. In cognitive behavioral therapy, clinicians teach patients to try to think more positively and do things that make them happy.
Dr. Brent said it was good news that drugs produced better results than talk therapy "because it's hard to get people into cognitive therapy anymore. They just don't want to take the time.''
The researchers said they plan to publish the preliminary results of the study this summer, with further analyses later.
Dr. Insel said that the most useful information from the study is yet to come. "We need to know which treatments work best for what kinds of kids and who may be the most vulnerable to the side effects,'' he said. Those sorts of answers would come from more data analysis, he said.
"We're going to get a lot out of this study that the public really needs to know right now,'' Dr. Insel said.
Corriere della Sera 3.6.04
Dubbi e polemiche sui risultati della ricerca: effetti positivi in sette casi su 10
La Sanità Usa: il Prozac può aiutare i giovani
Lo psicoterapeuta Scaparro: si può usare solo in casi estremi e con grande cautela
MILANO - «Bye bye blues», addio tristezza, pillola della felicità, i soprannomi per la fluoxetina (nome commerciale Prozac) l’antidepressivo di moda in America, si sprecano. A più di dieci anni dalla sua comparsa sul mercato, le prescrizioni della pillola negli Stati Uniti, alle stelle per gli adulti, riguardano anche diversi milioni di adolescenti. Nonostante le segnalazioni di effetti pericolosi indotti dal farmaco, primo fra tutti il rischio di suicidio, soprattutto nella fascia d’età giovanile. Segnalazioni riesaminate dagli esperti della Food and Drug Administration, l’ente di controllo statunitense, che nel febbraio scorso ha invitato i medici ad un uso estremamente accorto del preparato nei teenager.
Ora uno studio che ha coinvolto 439 ragazzi, dai dodici ai diciassette anni, che soffrivano di depressione, moderata o grave, sembra dimostrare che in tre mesi il Prozac, associato alla psicoterapia, riesca ad avere la meglio sull’umor nero nel 71% dei casi. Risultato che non si ottiene con il farmaco da solo, né con la psicoterapia da sola. L’importanza della ricerca, cui ha dato ampio risalto ieri il New York Times , scaturisce dal fatto che è stata finanziata dal National Institute of Mental Health (con fondi pubblici, pertanto), e non dalla casa produttrice del Prozac, la Lilly.
Il possibile via libera alla pillola della felicità ha suscitato dubbi e polemiche. Anche perché una revisione pubblicata in aprile sulla rivista British Medical Journal su fluoxetina e farmaci simili nei bambini e adolescenti depressi ha messo in risalto come l’efficacia e la sicurezza di tali preparati sia lungi dall’essere dimostrata. Ma anche che uno degli studi presi in considerazione, pubblicato nel ’97, pur vantando fondi governativi, aveva avuto la sponsorizzazione della Lilly.
«In Italia, a differenza degli Stati Uniti, c’è molta cautela quando il paziente è adolescente - commenta Fulvio Scaparro, psicoterapeuta a Milano -; farmaci come la fluoxetina vengono presi in considerazione in casi estremi, quando sono falliti tutti gli altri tentativi di cura. La strada farmacologica per eliminare la sofferenza che spesso accompagna un’età così complessa difficilmente si rivela adeguata».
