Yale University, School of Medicine
PRIME Research Clinic
Yale's New PRIME Research Clinic Is at the Forefront of Schizophrenia Treatment and Research
Tandy J. Miller, PhD
The Yale University Department of Psychiatry is introducing an exciting new treatment study focused on the early identification and prevention of psychosis called the PRIME (Prevention through Risk Identification, Management, and Education) Research Clinic. This program has been developed for people who, while in the prime of their lives, are at high risk for developing a debilitating mental illness. The goal of the program is to help these individuals continue to develop and achieve their personal goals. The novel approach of the clinic will test a treatment for young adults at risk for developing a psychotic episode with the aim of determining if it is possible to avert the transition from a pre-psychotic state to a full psychotic episode. The program will target young adults either prior to or in the initial stages of their first psychotic episode and offer them interventions that other-wise would not be available to them until they already had an established psychotic illness.
Research suggests that early intervention may be critical in affecting the course of illness in psychotic disorders. Mounting evidence indicates that a deteriorative process may be present early in the course of illness and possibly predate the onset of the illness. Results from a comprehensive review of patients suffering a first psychotic episode indicate that shorter duration of untreated illness or earlier treatment was associated with rapid treatment response and shorter duration of first hospitalization. These data, coupled with other results indicating the significant negative impact of untreated psychosis on the course of illness, have focused researchers and clinicians on early detection and intervention prior to the onset of "full blown" first episode symptoms.
Exploratory studies have found that it is possible to identify and treat people who are at high risk for developing psychosis or who are already in a prepsychotic stage, referred to as the "prodromal phase." Results from these studies, although preliminary, are promising in that they indicate that it is possible, at the very least, to relieve prodromal symptomatology and reduce the duration of untreated psychosis.
The first of its kind in the country, the goal of the PRIME Research Clinic is to explore whether this new knowledge will now allow the prevention of onset in psychosis altogether. While offering targeted treatment to high risk individuals, the program is primarily investigatory, with the hope that knowledge will be gained about preventing the chronicity associated with psychotic disorders through these targeted efforts to alleviate symptoms and restore functioning prior to the development of further deficits and disabilities.
Just as treatment can prevent relapse in patients with active illnesses, the PRIME Research Clinic investigators are hoping to see whether treatment also can delay onset or prevent it altogether. Thus, this work will shift the focus of research from the prevention of relapse in patients with active illness to the prophylactic prevention of psychosis, breaking new ground in schizophrenia research. The research at the clinic will also study the factors influencing the transition to psychosis in people who are at higher risk to improve the accuracy of identifying those who might benefit from this treatment approach.
This new Yale treatment research program is looking for people between the ages of 12 and 45 who are at high risk for the onset of these illnesses. This would include people who know they are genetically vulnerable for the development of psychosis because they have one or more first degree relatives with a psychotic illness such as schizophrenia. The program is also seeking to treat anyone who might be considered to be in the "prodromal phase" of an illness. People in the prodromal phase would be experiencing some symptoms and discomfort or attenuated psychotic symptoms.
Specifically, symptoms that have been found to be associated with the prodromal phase include the following:
having more difficulty working or studying,
having trouble thinking clearly, concentrating, or focusing,
feeling very tired or lacking in energy, difficulty sleeping
feeling suspicious or worried about the intentions of other people,
sensing changes in the way things sound or look, or noticing things in the environment that others don't notice,
feeling strange or having ideas that others find unusual,
feeling a changed or lost sense of self,
feeling uncomfortable around friends or family and wanting to be alone more often than usual,
having troubled feelings that are new or different or surprising, such as tension, anger, suspiciousness, or fear,
not having feelings when it is normal to do so,
feeling very confused and unclear about one's identity and future.
The Clinic is now inviting individuals who are interested in early intervention to participate in a treatment study. People who meet the "high risk" criteria outlined above are being recruited to participate. The research study has three parts. The first is an assessment phase, the second is a treatment trial phase of one year, and the third is a follow along phase of one year. The assessment phase includes a detailed, structured, diagnostic, signs and symptoms interview, including evaluations of functional abilities and cognitive (neuropsychological) capacities. The clinical trial phase involves randomizing the client to a new atypical neuroleptic medication or to placebo. This will be a double-blind study which means that no one will know who is receiving the placebo or the active medication during the course of the study.
During the trial, all participants will receive regular individual meetings with a clinician. In the beginning of the treatment trial, some of these meetings will include the client's family. Individual and family sessions will focus on support, psychoeducation, problem-solving training, and developing strategies for stress reduction. Clients also will undergo ongoing clinical and research assessments during the trial.
The follow along phase will involve standardized sign, symptom, and functional assessments on a regular basis. In addition, participants will continue to receive supplementary individual and family interventions as needed. If psychosis develops at any point during the study, the double-blind medication trial will be stopped and the client will receive active medication in doses tailored to his or her condition. All of the treatment for people participating in the study will be provided free of charge. At the end of two years, the ongoing needs of each participant will be assessed and appropriate referrals will be arranged.
Referrals can be made to the Clinic by calling 1-800-ASK-YALE and asking to be connected to the PRIME Research Clinic. Sometimes the signs and symptoms of this population can be difficult to determine because changes are often subtle and can be masked by other behaviors and experiences. If you are unsure whether you are someone, know someone, or have a referral who meets these criteria, or if you would like more information on the PRIME Research Clinic and young people at risk for psychosis, further material is available. Please call 1-800-ASK- YALE and ask for the PRIME Research Clinic. The development of the PRIME Research Clinic represents an investment in the idea that early intervention aids prevention and recovery in the initial stages of a psychotic illness. At the same time, very little knowledge exists about pre-psychotic states. The researchers and clinicians at the PRIME Research Clinic are among the very few groups in the world, and the first in the United States, who are in the position to gain such valuable knowledge.
The PRIME Research Clinic is a collaborative effort between the Yale Psychiatric Institute and the Connecticut Mental Health Center (CMHC) and is located at The Yale Psychiatric Institute at 184 Liberty Street in New Haven, CT.