Five suicides had occurred among 4,124 depressed subjects in studies of the drug. One subject had taken only a placebo. In a recent study of about 1,000 depressed people taking duloxetine for up to a year, seven people attempted suicide and seven others reported that they'd thought seriously about it.
Breier said that was less than would be expected in a group of depressed patients. The annual suicide rate in the general population is about one in 10,000. The risk in people diagnosed with depression can be 10 to 30 times higher.
For The Record
Los Angeles Times Saturday April 03, 2004 Home Edition Main News Part A Page 2 National Desk 1 inches; 33 words Type of Material: Correction
Drug trial suicide -- An article in Friday's Section A about a young woman's suicide during a test of an antidepressant incorrectly gave the name of Indiana University as the University of Indiana.
Lilly spokesman David Shaffer said that because data did not link duloxetine to suicide, a history of depression -- even a past suicide attempt -- would not necessarily disqualify somebody from the trial.
Several people in the trial had struggled with moodiness and despair.
Yullan Valor, a freelance product consultant, was among about two dozen subjects who took part in the duloxetine trial at California Clinical Trials in Glendale. She said screeners seemed interested only in depression suffered during the last seven years. She said they did not ask for details about the depression she said she suffered two decades ago -- and so never learned that she had once called a suicide hotline for counseling.
Tatiana Sikic, another participant, didn't tell screeners that five years ago she cut her wrists and took some pills in an attempt to kill herself.
All she said was that she had a history of depression.
"I really needed to be in the study," said Sikic, who was out of work at the time. "And I felt fine."
A Host of Odd Reactions
On Jan. 10, Johnson, along with the Bible college's secretary and another student, entered the enclosed world of Lilly's clinical drug trial.
The experience blends dorm living and medical quarantine. Subjects share meals and TV time, opinions and life stories, forming a makeshift community.
In this study, subjects took duloxetine twice a day. At regular intervals, the medical staff took blood samples and checked heart rhythms.
Each participant took the drug for 20 days: 16 days working up to a dose of 400 milligrams of duloxetine, followed by a four-day weaning period in which the dosage dropped to zero. For the rest of the study, they were given a placebo.
Almost everyone had some odd reaction to the drug. Some could not sleep. Others could not get out of bed. There was constant bickering.
One woman at the Glendale site said she was stunned when she felt an overwhelming urge to run over her husband with the family car as he walked past. Some subjects cut in front of Alzheimer's patients for use of coveted VCRs.
"It was turning into a madhouse," said 38-year-old Carmellia Wright, an actress. "Every minute someone was breaking down crying or laughing."
Two weeks into the experiment, Johnson dropped out of school. Even though she could leave the clinic, she was missing classes and skipped the funeral of her grandfather.
Still, she found time to socialize. And there was a young man, a sophomore, a Christian. "I LOVE his love for you," she wrote to God about the boy in her diary. "God, please work it out."
They quarreled, but on Jan. 28 -- a day when she took the maximum 400-milligram dose of duloxetine -- they went on a date and parted with a kiss. "So yeah talking about DRAMA!!" she wrote in her diary.
She took 240 milligrams the next day, beginning a withdrawal period when brain chemicals can swing wildly. On Feb. 3, Johnson took 120 milligrams of duloxetine before starting on the placebo.
She seemed fine and baby-sat three nights later, telling one mother she couldn't wait to get back to school. She talked with friends back home and was anxious to be there for the delivery of her sister's baby.
At 3 p.m. the next day she spoke by phone with John Crompton, a church friend from Philadelphia, and told him she felt sick and needed to rest.
Sometime in the next few hours, the young woman took the multicolored scarf that she wore around her waist and looped it around her neck. She tied the other end to a shower rod.
And there she hung, feet dangling close to the floor, until a nurse found her body shortly after 8:30 p.m.
The Rev. Joel Barnaby, Johnson's pastor back home in Pennsylvania, broke the news to her parents in their living room.
Reporters barraged Lilly with questions.
At one of the trial sites, in Evansville, Ind., directors shut down the study, sending home all 16 subjects, according to a Lilly spokesman. But enough people remained in the study to ensure the trial was still scientifically valid, the spokesman said.
Lilly assured stockholders that the suicide would not delay the drug's release later this year. The company also reported Johnson's earlier pill-swallowing episode to the FDA and the scientists who were studying duloxetine for Lilly.
While company officials declined to comment in detail on Johnson's death, they said they did not believe the duloxetine contributed to it -- and that the reasons behind her suicide were a mystery. She left no note.