University researchers will participate in two of the largest-ever studies evaluating the effectiveness of a new generation of schizophrenia drugs used to treat an illness that often manifests itself around the transition from adolescence to adulthood.

The studies seek to provide researchers with valuable information about how newer medications are tolerated by patients compared with older-generation drugs whose benefits sometimes come at the cost of debilitating side effects.

Both the old and new drugs have been tested but not against each other on this scale.

The Clinical Antipsychotic Trials of Intervention Effectiveness trial will enroll patients that have been diagnosed with schizophrenia or a related disorder.

Those enrolled in the Comparisons for Atypicals for First Episode trial will be in the first stages of a psychosis, having been on schizophrenia drugs – known as antipsychotics – for less than four months.

Elizabeth Lemke, coordinator of the CATIE trial and assistant coordinator of the CAFE trial, said the studies will try to imitate real-world clinical practice and situations. Researchers will not use placebos and there are few restrictions placed on the studies’ participants.

For example, participants can be taking other medications, can have hyper tension or diabetes, go off their medication or skip appointments. Potential participants will not be excluded even if they are alcoholics or using street drugs, Lemke said.

Study participants will undergo physical and cognitive testing and will be monitored for side effects from the medications. The studies also provide patients with access to counseling and education in addition to medical and psychiatric care.

Stephen Olson, a University associate professor of psychiatry, said the importance of the studies lies in finding, “which medications people seem to prefer to stay on over a long term and under real world conditions.”

Problems in the treatment of schizophrenia often arise when patients go off medication or switch medications frequently.

For example, some patients stop taking their medication once it has relieved their symptoms. However, most of those patients will relapse within two years, some suffering from more severe symptoms.

Also, many patients fare better when they stay on one medication for a long time rather than switching medications, Olson said.

Finding which drugs work best for different people might also help avoid the risks associated with taking them. While the older drugs might be more effective for some, their benefits come with the burden of serious side effects.

Olson said all classic antipsychotics – drugs developed in the 1950s through the early 1990s – can lead to a temporary condition similar to Parkinson’s disease. Some taking the drugs become shaky, suffer from stiffness in their muscles, get restless or “look zombie-like in the most extreme forms,” Olson said.

Among long-term users of these classic antipsychotics, approximately 30 percent to 40 percent could develop a potentially irreversible movement disorder, Olson said. The newer medications have a substantially lower incidence of those side effects.

ne of the CAFE participants is Jacob, a University first year majoring in English, who wished to be identified only by his first name. He is schizoaffective – displaying many of the symptoms of the disorder, but not yet diagnosed with full-blown schizophrenia.

Now 19, the symptoms of schizophrenia appeared unusually early for Jacob, when he was in his early teens.

“It was really horrible,” he said. “I was paranoid, I thought everybody was out to get me, I had delusions of grandeur.

“Half the time, I would closet myself in the house, just to get away from all those evil, bad things out there that weren’t really there.”

Although his family noticed he “wasn’t really social,” other serious family issues prevented them from realizing the extent of the problem, Jacob said.

A year or two before coming to the University, he began to realize he had an illness.

“After a while, I started questioning it all, and I came to the realization that it just didn’t make sense,” Jacob said.

He began to “half seriously” research mental illnesses and found his symptoms “just really match up well with schizophrenia.”

At the University, Jacob talked with a doctor about possibly having schizophrenia and was sent to see Olson, who enrolled him in the CAFE study. Jacob began taking medication in December.

Although Jacob has been living with schizophrenia-like symptoms for years, others enrolled in the CAFE study – which focuses on those who have not been on medication long or at all – may have only recently had their first psychotic episode.

In these cases, recognition of the symptoms is very important, as recent research indicates early treatment might prevent or prolong the development of full-blown symptoms, Olson said.

Although the reasons for it are unclear, the symptoms of schizophrenia often develop – the end of adolescence and the beginning of adulthood – the age of a younger college student or high school student, he added.

Olson said some people may have a predisposition to the illness that interacts with the stresses of transitioning to adulthood, triggering a breakdown.

Another possibility is that the brain typically matures to a point at that age that allows people to make “critical and complex life decisions.” For some reason, something prevents schizophrenics from developing that ability fully.

He said some people might struggle with the disease for a while before having a breakdown. The preliminary symptoms might appear as depression, withdrawal or difficulty with school or social situations. The person might become paranoid or exhibit odd behavior.

Many others, however, develop symptoms of psychosis within several days or weeks, Olson said.

Olson likens a person with untreated schizophrenia trying to function on a day-to-day basis to a car with a malfunctioning overdrive. He said they “… might be able to keep up in city streets at low speed, but as they get on the highway, they may be able to keep up even for a short time, but the engine’s running way too fast – eventually it will burn up, blow up or it’ll just stop.”

But for Jacob, his involvement with the CAFE study has already had positive effects. Since going on medication, he has noticed he focuses more easily, does better in class and is dealing better with life in general.

Before going on medication, when faced with a problem in his life, he said he would “hide in my room and just basically try to ignore it.”

Now, he said, “If there’s a problem, I go out there and just Ö face it and deal with it.”