Are Researchers Cherry Picking Participants For Studies Of Antidepressants?
ScienceDaily (Apr. 29, 2009) — Findings from clinical studies used to gain Food and Drug Administration approval of common antidepressants are not applicable to most patients with depression, according to a report led by the University of Pittsburgh Graduate School of Public Health.
Published in the May issue of the American Journal of Psychiatry, the study suggests only a small percentage of people with depression qualify for these studies, and those who do not qualify are often treated with the same medications but may suffer poorer clinical outcomes.
A part of the National Institute of Mental Health-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project – the largest study of the treatment of depression conducted in the United States – researchers compared symptoms and outcomes in depressed patients who met phase III study inclusion criteria to those who did not. Phase III studies for antidepressants determine the effectiveness of the drug in comparison to a placebo. The inclusion criteria for these studies are not standardized nor subject to federal guidelines, resulting in some variation from study to study in the profile of eligible patients. Typically excluded are patients with milder forms of depression, who might be more likely to respond to a placebo drug, and those who may have chronic depression or psychiatric and medical co-morbidities – additional illnesses or conditions.
After assessing 2,855 patients treated with citalopram, a commonly prescribed selective serotonin reuptake inhibitor for mood disorders, study authors concluded that fewer than one in four, or 22.2 percent, of the patients met the usual criteria for inclusion in phase III antidepressant trials.
"Only a small percentage of depressed patients in our study would have qualified for inclusion in phase III efficacy trials of depression drugs," said study lead author, Stephen Wisniewski, Ph.D., professor of epidemiology and co-director of the Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health. "This raises major concerns about whether results from traditional phase III studies can be generalized to most people with depression, who also often suffer from anxiety, substance abuse and other medical and psychiatric problems."
When Dr. Wisniewski and colleagues further assessed how well patients did on treatment, they found that those who met the eligibility criteria for phase III trials had better outcomes, including higher remission rates, less severe side effects and serious adverse events. The depression remission rate in the patients who met the criteria was 34.4 percent, compared to only 24.7 percent in the ineligible group. Additionally, the drug response rate also was higher in the eligible group – 51.6 percent compared to 39.1 percent of the ineligible group.
"Results from research studies suggest more optimistic outcomes than may exist for real-world patients receiving treatment for depression," said Dr. Wisniewski. Although phase III eligibility criteria could be changed to include a broader population of patients, Dr. Wisniewski cautions that this could come at the cost of more serious side effects in patients who have co-morbidities and are generally sicker. These patients may not be able to safely tolerate the drugs being tested. Instead, he suggests medical care providers who treat patients with depression use their professional judgment by noting that most phase III findings are based on patients who may be very different than those under their care.
The study was funded by the National Institute for Mental Health. Co-authors include A. John Rush, M.D., National University of Singapore; Diane Warden, Ph.D., M.B.A., and Madhukar Trivedi, M.D., University of Texas Southwestern Medical Center; Andrew Nierenberg, M.D., and Maurizio Fava, M.D., Harvard Medical School; Bradley Gaynes, M.D., M.P.H., University of North Caroline School of Medicine; James Luther, M.A., University of Pennsylvania School of Medicine; Patrick McGrath, M.D., Columbia University Medical Center; Philip Lavori, Ph.D., Stanford University School of Medicine; and Michael Thase, M.D., University of Pittsburgh School of Medicine.
Columbia Daily Spectator
COLUMBIA UNIVERSITY
Theater April 26, 2009 - 11:56pm
Broadway and TV put mental illness on center stage
by Liz Lucero, Lily Cedarbaum, Laura Hedli, and and Kelicia Hollis
In conjunction with Spectator’s “Mind Matters” series, several A&E reporters explored the manner in which mental illness is depicted and examined in entertainment. Famous artists are not exempt from mental illness, and many have recently used their art as not only a means of catharsis, but also as a forum for discussing their illnesses. In the past few months alone, theater and television have addressed depression, bipolar disorder, suicide, ADHD, and the role mental health plays in our society.—Ruthie Fierberg
NEXT TO NORMALFormer Columbia students Brian Yorkey. CC ’03, and Tom Kitt, CC ’96, are the creative forces behind Next to Normal. Originally entitled Feeling Electric, the musical concerns the unraveling of a nuclear family trying to come to grips with the delusions of its troubled matriarch.
Diana (played by Alice Ripley) is a suburban housewife who suffers from bipolar disorder. Haunted by a tragic event in her past, she seeks a combination therapy of specialists and pharmacological cocktails. Meanwhile, her husband struggles to cope with her illness, her daughter hankers for her parents’ attention, and her son remains the omnipotent golden boy. The musical had its start at the New York Musical Theatre Festival in 2005, and made its off-Broadway debut at Second Stage Theatre last season.
Unique in content, Next to Normal was the only production to ever feature a song and dance in Act I that closely detailed the risky psychiatric procedure of electroshock therapy. But with its uptown transfer, its creators have done away with this controversial scene in the operating room, and director Michael Greif (of Rent) has opted for sincerity.
It was a wise choice, because while Next to Normal doesn’t promise happy endings, it makes you feel anything but numb. Composer Kitt and book writer and lyricist Yorkey have created an addicting pop-rock score that moves a taboo subject to Broadway’s center stage.—Laura Hedli
Next to Normal is playing at the Booth Theatre (222 W. 45th Street). Rush tickets are available for $25, and regular tickets can be bought at www.telecharge.com.
KERNEL OF SANITYWhen a show leaves you confused about what happened, you know the topic will circulate in your head for a long time after the final bows. Such is the case with New Federal Theater’s Kernel of Sanity.
Set in the ’70s, Kernel of Sanity is about a day in the life of Frank Tracy, a washed-up actor who retreated to the Midwest to escape his past. Later we meet his reluctant girlfriend, Rita, and Roger Peterson (a fellow actor from their past collaboration on One Flew Over the Cuckoo’s Nest).
On the surface, the theme of insanity enters the play when Frank receives a letter from the government. They have registered him as mentally insane, a label that results in a monthly stipend. But this is just the tip of the iceberg.
When Roger stops by unannounced, his long periods of silence mixed with enraged tangents about becoming Smokey Robinson beg the question—who is really insane?
What was fact at the beginning of the show eventually turns into fiction. Rita tells Frank she is pregnant, but later claims that she was only proving she could act. Roger admits to having murdered a producer. When Frank asks him if it is true, Roger refuses to tell him.
They all know their lives are on a downward slope toward self-destruction, yet none of them try to stop it. Roger carries around a prop gun, Frank is perpetually writing his autobiography, and Rita has a psychotic obsession with Janis Joplin. The levels of lunacy rise more and more until all sense of reality is lost.
What the characters learn is that mental instability is not a joke. Because of mental disintegration, people become recluses, pathological liars, and even murderers. The worst part is that you don’t even realize you are insane until it is too late. All you can do is hope that there is just one Kernel of Sanity left.—Lily Cedarbaum
Kernel of Sanity is playing at the Henry Street Settlement (465 Grand Street) until May 3. Call 212-598-0400 for tickets, which are available for $20.
BREAKING BADIn AMC’s hit drama Breaking Bad, the name of the game is desperation.
Although it affects everyone to a certain extent, desperation takes a significant toll on the show’s protagonist, high school chemistry teacher Walter White (Bryan Cranston)—it pushes him to open up his own crystal meth lab, and subsequently to the edge of his sanity.
In the pilot episode, Walt frantically drives the RV that doubles as his meth lab through New Mexico, wearing only underwear and a gas mask, and with a gun in tow. Just three weeks before this first scene, he was a normal (albeit bored) family man. However, soon after his 50th birthday, he is diagnosed with stage three terminal lung cancer.
Faced with the realization that there will not be enough money for his wife Skyler (Anna Gunn), his son Walter Jr. (RJ Mitte), who has cerebral palsy, and his unborn daughter to survive when he is dead, Walt looks for a way to provide for them. He decides to put his chemistry skills to good use: cooking and dealing crystal meth with one of his former students, Jesse Pinkman (Aaron Paul).
This decision splits Walt into two very different people. At home, he tries to be the loving husband and father he has always been. In the drug world, he is Heisenberg, the absolutely ruthless man who makes the purest meth. The stress of his double life makes it almost impossible for him to function well in either role.
Now in its second season, the show makes it hard to tell how tight of a grip Walt actually has on his sanity. Nonetheless, it is visibly becoming more difficult for him to live with himself, the things he has done, and the things he knows he will do.
In last Sunday’s episode, “Negro y Azul,” the show highlighted the increasing flimsiness of Walt’s justification for his meth business. He is becoming a big shot as Heisenberg, testing the limits of his morality as a cold-blooded dealer. He manipulates Jesse and convinces him to expand their operation.
In terms of securing his family’s future, expanding the business may be the best move for Walt—but at what cost? Steadily, he is creating enemies much more threatening than himself, and the precious time he has left with Skyler is strained, as she is now beginning to suspect that he is hiding something.
Walt is playing a dangerous game with both the law and his health, and it seems that there are few, if any, safe exits left. Big problems loom for this divided soul, and he may lose more than he hoped to win.—Liz Lucero
Breaking Bad airs Sundays at 10 p.m. on AMC.
FOR COLORED GIRLS WHO HAVE CONSIDERED SUICIDE WHEN THE RAINBOW IS ENUF“Sometimes you have to dance to keep from dyin’,” the women declared as they danced and stepped onstage, each unified with the others yet distinguishable by her respective colors.
Ntozake Shange’s For Colored Girls Who Have Considered Suicide When the Rainbow is Enuf—presented this past weekend by Columbia’s Black Theater Ensemble—is a choreopoem exploring the plight of women of color. The women’s stories are of mental and sexual abuse, exploitation, and manipulation.
Each woman represents a distinct color, just as each one struggles with distinct situations that have exacted all her strength and exhausted her to frailty of stature and will. The play deals with the way “colored girls” are perceived in the world, but, more importantly, it also deals with how they view themselves.
For Colored Girls consists mainly of monologues, one overlying theme of which is the exhaustion of women who are historically supposed to be able to handle everything. Their questioning of their entire existence is described by Lady in Yellow: “bein alive & bein a woman & bein colored is a metaphysical dilemma.”
Despite this inner conflict, the play is not about suicide, but rather about the strength and communal support it takes to prevent mental collapse. The women help each other through their suffering, and celebrate the reclaiming of mind, body, and essence through dance, song, and step.
The unity of the bright colors is a constant reinforcing connection that prevents the women from becoming mentally insane. In many ways, both the written work and the production’s use of light and color render depression and suicide a solitary and lonely act—in stark contrast to the happiness the women want for themselves. But they dance to keep from dying, illustrating that unity is the most useful survival technique.—Kelicia Hollis
Sunday, May 3, 2009
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