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Hospital accepting patients for schizophrenia drug study

New Britain [July 07 2008] - The Hospital of Central Connecticut is accepting applicants for a clinical trial investigating a drug to treat cognitive deficits common in patients with schizophrenia.

The hospital is one of about 75 study centers in the United States and Canada studying effectiveness of the drug AVE1625 in improving cognitive skills such as memory, concentration and planning ability in patients with schizophrenia.

“Right now, there are no known medications for the cognitive deficits seen in schizophrenia,” says Michael Balkunas, M.D., chief of Psychiatry and Behavioral Health Services at The Hospital of Central Connecticut. “We’re really in a groundbreaking area in terms of developing a medication for treatment for these dysfunctions.”

Schizophrenia is a severe and disabling brain disorder that can affect the ability to think clearly, manage emotions, distinguish between fantasy and reality, make decisions and relate to others.

The drug, made by sanofi-aventis, is in phase two of the clinical trial process, having been previously tested in subjects without schizophrenia. AVE1625 is available in three dose levels; study participants will either receive the drug or a placebo (pill without medication). The drug will not be given to participants once the study is complete.

To qualify for the trial, patients must be between 18 and 65 years old; have been diagnosed with schizophrenia before age 35; be currently treated with Zyprexa® (olanzapine), Risperdal® (risperidone), Invega® (paliperidone), Seroquel® (quetiapine), or Abilify® (aripiprazole); and have had stable housing within the past three months. Hospital psychiatrists will communicate on a regular basis with participants’ physicians.

The 35-week study requires 18 visits, including screening for potential participants, at the Department of Psychiatry and Behavioral Health Research, 32 Hawkins St. During the visits, participants will have a variety of tests and procedures. For more information, please contact Alison Oville, psychiatry research manager, at (860)-224-5597.

Contact: Kimberly Gensicki, 860-224-5900, ext. 6507

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