A 19-year-old college student committed suicide over the weekend of Feb. 6, after participating in a trial for the drug duloxetine at the Eli Lilly & Company laboratory in Indianapolis.

Traci Johnson, a student from Indiana Bible College, was given a placebo in replacement of duloxetine four days prior to her suicide. Like the anti-depressant Paxil, duloxetine quickly leaves the bloodstream if the drug is no longer taken.

Duloxetine, a drug to be marketed as Cymbalta with the approval of the FDA, was administered in doses exceeding therapeutic amounts to a group of 25 patients in the study.

Johnson, a voluntary participant in the trial, was in good health upon the commencement of the study and did not show signs of depression during the trial.

David Shaffer, a spokesman for Eli Lilly & Company, said no direct connection has been found between duloxetine and the cause of Johnson’s death.

“We’ve had clinical trials involving more than 8,500 patients, and while we continue to work to understand the circumstances around this tragedy, we haven’t seen anything in our data to suggest any connection between her participation in our study and her death,” he said.

However, according to Dr. David Kass, a psychiatrist in private practice in Manhattan, some patients who are abruptly taken off of certain anti-depressants can experience withdrawal symptoms that include night sweats and agitation.

“Too-rapid withdrawal from certain types of medication might cause deterioration in mood,” Kass said.

A study conducted by GlaxoSmithKline, the company that distributes Paxil, found that children and teenagers given Paxil were at greater risk to commit suicide than patients not given the drug.

Kass said a drug withdrawal may be too simple an explanation for Johnson’s death.

“The complex interaction between biology and psychology is such that it’s all too easy to say that a person committed suicide because they withdrew from medication.”

The process of many psychological clinical screenings relies upon the results of a group of “unhealthy” people, which are then used to implicate the mental health of a control group of “healthy” patients.

Kass said self-reporting screening processes patients endure prior to participation in a trial could have contributed to Johnson’s death.

Because the trial is a healthy volunteer study, Shaffer said, the company did not recruit anyone with disorders that could be treated by the drug.

Kass noted the possibility Johnson might have had a psychiatric disorder the screening processes did not identify.

“This could be somebody who might have had some vulnerability to a mood disorder that wasn’t picked up,” he said.

Upon the formation of a clinical drug trial involving human subjects, both the United States Food and Drug Administration and the Institutional Review Board (IRB) become involved. The Indiana School of Medicine IRB is responsible for the evaluation of Eli Lilly & Company’s duloxetine trials.

After the IRB became aware of Johnson’s death, Shaffer said the company made the changes asked of them to modify patient testing procedures, and Eli Lilly & Company remains in contact with the IRB.

“We have continued the research study in which Ms. Johnson was participating almost every day, and always have the safety of the participants in our mind,” he said.

The study of the correlation between duloxetine and an increase in suicidal tendencies is one that, according to Shaffer, takes years of work to put together.

“We have ongoing research into duloxetine and we’re doing research in an informal sense in terms of gathering information as to why this young woman took her life,” he said.

Shaffer said the FDA and IRB are responsible for determining whether the testing of duloxetine can continue.

At present, no legal action with regard to the testing has been taken against Eli Lilly & Company by the Johnson family or other parties. Shaffer said patient safety is presently the company’s primary concern.

“The sad fact is that suicide often leaves everyone unable to understand why the suicide happened,” he said. “We may never know completely why Ms. Johnson took her life, but we’re going to do everything we can to understand what happened.”