Title: "Long-Term Lorazepam Use and Acute Toxicity in the Aged"
Principal Investigator: Nunzio Pomara, M.D.
Site: Nathan S. Kline Institute for Psychiatric Research
Contact Person: Dr. Corazon de la Pena, at (845) 398-6533
Description of Study: This project is examining whether elderly people on long-term treatment with lorazepam develop a tolerance to the acute adverse performance effects of the medication.
Eligibility: Those 60 years of age or older who are anxious and currently receiving daily lorazepam (Ativan) treatment are being sought for this study.
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Title: "ApoE e4 Allele and Lorazepam Effects on the Elderly"
Principal Investigator: Nunzio Pomara, M.D.
Site: Nathan S. Kline Institute for Psychiatric Research
Contact Person: Dr. Corazon de la Pena, at (845) 398-6533
Description of Study: This study examines the cognitive effects of one of the benzodiazepines in the population most at risk for the deleterious effects of the e4 allele on brain function: older, non-demented, cognitively intact individuals, some of whom may have a documented history of Alzheimer’s disease in a first degree relative and possess an e4 allele (ApoE e4/e4 or e3/e4 genotype). They are compared with an appropriate, age-matched control group without the e4 allele. The research is designed to directly assess whether the e4 allele is associated with increased susceptibility to drug-induced cognitive toxicity in normal cognitively intact older persons.
Eligibility: Subjects must be 60-74 years of age and must meet screening criteria for physical exams and cognitive tests.
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Title: "ApoE e4 Allele and Trihexyphenidly HCI (Artane) Effects on the Elderly"
Principal Investigator: Nunzio Pomara, M.D.
Site: Nathan S. Kline Institute for Psychiatric Research
Contact Person: Dr. Corazon de la Pena, at (845) 398-6533
Description of Study: In a related project to the one listed above, this study examines the relationship between allele variability of the ApoE gene and sensitivity to the performance effects of acute doses of Artane, a commonly prescribed anticholinergic agent.
Eligibility: Subjects must be 60-74 years of age and must meet screening criteria for physical exams and cognitive tests.
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Title: "ApoE Genotype and Vulnerability to HIV-induced CNS Dysfunction"
Principal Investigator: Nunzio Pomara, M.D.
Site: Nathan Kline Institute (NKI) in collaboration with the NYU/Bellevue AIDS Clinical Trial Unit
Contact Person: Dr. Corazon de la Pena, at (845) 398-6533
Description of Study: Studies have shown that approximately a third of the adults and half of the children with a diagnosis of AIDS eventually manifest neurological complications. The basis for individual variability in HIV-induced CNS dysfunction is not known. Consequently, the development of predictors of HIV-induced CNS dysfunction is of great importance because of the high frequency of CNS complications that may develop in the course of the disease, and the deleterious effects that they can have on the individual’s quality of life. This study will seek to identify whether cognitively intact, HIV seropositive subjects with the e4 allele will show an enhanced sensitivity to the negative cognitive effects of lorazepam compared to properly matched controls without the e4 allele.
Eligibility: The target study population will consist of asymptomatic HIV-1 seropositive patients without significant cognitive impairments, and with CD4+ count > 200/ml, who do not have acute medical illness, history of non-HIV-related neurologic disease, space-occupying HIV-related CNS disease, cardiovascular disease, psychotic disorders, learning disability, a history of alcoholism, current or past IV drug abuse, or psychoactive substance abuse.
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Title: "Vitamin E in Aging Persons with Down Syndrome"
Principal Investigator: Nunzio Pomara, M.D.
Site: Nathan Kline Institute (NKI)
Contact Person: Dr. Corazon de la Pena, at (845) 398-6533
Description of Study: This multicenter study will determine whether treatment with vitamin E1000 IU twice daily slows the rate of cognitive/functional decline in individuals with Down syndrome 50 years of age or older.
Eligibility: Individuals with Down syndrome 50 years of age or older.
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Title: Risperidone, Olanzapine, and Clozapine in Chronic Schizophrenia
Principal Investigator: Jan Volavka, M.D., Ph.D.
Sites: Rockland Psychiatric Center (RPC), MPC, and North Carolina (Dorothea Dix Hospital, John Umstead Hospital)
Contact Person (NKI/RPC): Meredith Platt, Ph.D., at (845) 398-6573
Purpose: The general aim is to develop optimal treatment strategies for treatment-resistant schizophrenia and, in that regard, to determine the comparative efficacy of typical and selected atypical antipsychotic drugs.
Methods: Three strategies are being used: a 14-week parallel-group double blind trial comparing four treatments (risperidone, olanzapine, clozapine, and haloperidol), and a 14-week open-label trial of olanzapine for those patients who did not respond to risperidone, clozapine, or haloperidol in the double-blind study. A third option that is available is a 14-week open-label trial of olanzapine for those patients who are ineligible for the double-blind trial yet who are treatment-resistant to typical antipsychotics. Patients will receive $10 for each week they are in the study. Repeated measures of safety and efficacy are conducted throughout the study.
Eligibility: Participation is open to inpatients at RPC age 18 to 60 years; Males or females; DSM-IV diagnosis of schizophrenia or schizoaffective disorder. Other specific inclusion/exclusion criteria must be met.
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Title: Pharmacogenetics and Antisocial Behavior in Schizophrenia
Principal Investigator: Jan Volavka, M.D., Ph.D.
Sites: Rockland Psychiatric Center
Contact Person: Karen Nolan, Ph.D., at (845) 398-6572
Purpose: Violence among patients with schizophrenia is a serious problem in the hospital and in the community, although not all patients with schizophrenia engage in aggressive behaviors. We are studying a gene which may be related to antisocial behavior in schizophrenic patients. COMT is an enzyme that has an important role in dopamine metabolism. This study will compare the relative frequencies of the different COMT genotypes in violent versus non-violent patients with schizophrenia and schizoaffective disorder. Other factors which may also contribute to the propensity to violence will also be examined; these include personality traits, intelligence, religious beliefs and structural neurological abnormalities.
Methods: Genetic material is obtained from a single blood sample. In addition, standardized neuropsychological tests and interview/questionnaire measures of empathy, impulsiveness, and religious beliefs are administered and an MRI examination of the brain is performed. Subjects may choose not to complete the questionnaires and/or the MRI.
Eligibility: Participation is open to inpatients at RPC, to residents of community care facilities on the grounds of RPC and to outpatients at the Pomona Young Adult Center and the Garnerville Community Support Center. Participants must be 18 or older and must be diagnosed with DSM-IV Schizophrenia or Schizoaffective Disorder. In addition, they must have documented history of either (a) multiple incidents of assaults against or (b) no assaultive or threatening behavior.
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Title: "A Multicenter, Double-Blind, Placebo-Controlled, Flexible Dose Evaluation of the Safety and Efficacy of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients With Bipolar Disorder"
Principal Investigators: Norman Sussman, M.D., James C.-Y. Chou, M.D.
Site: Bellevue Hospital Center, New York University Medical Center
Contact Person: Owen Charles, at (212) 562-3456
Purpose: The purpose of this study is to evaluate the safety and efficacy of lamotrigine, compared to placebo, as a monotherapy treatment for a major depressive episode in adult patients with Bipolar I and Bipolar II disorder. The study will also compare the quality of life of patients treated with lamotrigine to those on placebo.
Methods: The study will be a 10-week multicenter, double-blind, placebo-controlled monotherapy trial in patients with bipolar disorder who are currently experiencing a major depressive episode.
Eligibility: Adults with DSM-IV diagnosis of Bipolar I or Bipolar II, current episode depressed of 2 to 52 weeks. Certain other DSM-IV diagnoses, including panic disorder, obsessive-compulsive disorder, social phobia or bulimia nervosa are excluded. Patients with unstable medical illnesses, those who are suicidal or who have previously been treated with lamotrigine may not participate.
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Title: "A Multicenter, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Evaluation of the Safety and Efficacy of Lamotrigine in the Long-Term Prevention of Mood Episodes in Patients with Bipolar Disorder with Rapid Cycling"
Principal Investigators: Norman Sussman, M.D., James C.-Y. Chou, M.D.
Site: Bellevue Hospital Center, New York University Medical Center
Contact Person: Owen Charles, at (212) 562-3456
Description of Study: The purpose of this study is to evaluate the safety and efficacy of lamotrigine in preventing mood episodes in patients with bipolar disorder (I or II) with rapid cycling. This is a multicenter, double-blind, placebo-controlled, flexible-dose, parallel-group study.
Eligibility: Adults with DSM-IV Bipolar Disorder (I or II) who have exhibited rapid cycling (as defined by DSM-IV). Certain other DSM-IV diagnoses, including panic disorder, obsessive-compulsive disorder, social phobia or bulimia nervosa are excluded. Patients with unstable medical illnesses and those who are suicidal or have a history of substance or alcohol abuse or dependence may not participate. Patients who have previously been treated with lamotrigine are also excluded.
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Title: "A Multi-Center Pilot Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With Schizophrenia Or Schizoaffective Disorder Followed By An Optional Extension Phase With Continued Ziprasidone Treatment"
Principal Investigators: Norman Sussman, M.D., James C.-Y. Chou, M.D.
Site: Bellevue Hospital Center, New York University Medical Center
Contact Person: Owen Charles, at (212) 562-3456
Purpose: The purpose of this study is to examine whether differences exist in clinical outcome between three methods of switching patients with schizophrenia or schizoaffective disorder from treatment with their currently prescribed antipsychotic drug to treatment with ziprasidone.
Methods: This is a six week, blinded rater pilot study. Subjects will be randomized to one of three methods of switching medications, after which they will continue to receive ziprasidone alone for up to six weeks. Subjects who are clinically stable at the end of the six weeks will have the option to continue treatment with ziprasidone in an open label continuation study.
Eligibility: Adults with DSM IV diagnosis of schizophrenia who have been out of hospital and treated with oral doses of antipsychotic medication as outpatients for a minimum of 3 months. Patients with unstable medical illnesses and those currently treated with thioridazine, pimozide, olanzapine, risperidone, or clozapine are not eligible. Patient who have a positive urine drug screen for alcohol, cocaine, benzodiazepines, or marijuana and meet the DSM-IV criteria for psychoactive substance dependence or psychoactive substance abuse are also excluded.
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Title: Early Cortical Processing in Schizophrenia
Principal Investigator: Daniel C. Javitt, M.D., Ph.D.
Sites: Nathan Kline Institute, the County of Rockland Department of Mental Health at Pomona – Young Adult Center (YAC) and the outpatient residential facility at Rockland Psychiatric Center (RCCA) and NKI.
Contacts: Esther Rabinowicz, Ph.D., at (845) 398-6543; Gail Silipo, M.A., at (845) 398-6536.
Purpose: Schizophrenic subjects, as a group, show severe deficits in the ability to perform activities of daily living and tasks necessary for autonomous functioning. In structured testing, schizophrenic subjects have difficulty in virtually all complex tasks that they are requested to perform. This research seeks to identify the simplest deficits that might cause cognitive dysfunction in schizophrenia, and to identify particular patterns of brain activity that might be associated with cognitive abnormalities.
Methods: Cognitive testing will be administered primarily by computer. Patients will be seated in front of a computer screen and asked to respond to specific sequences of tones and/or letters. The specific sequences will be chosen to test specific aspects of cognitive functioning (e.g. "memory", "attention", "perception"). For some sessions, EEG ("brain wave") recordings will be obtained at the same time as the cognitive testing. For those sessions, subjects will have a small cap with EEG electrodes placed on their heads. Recordings will be monitored by computer. Both cognitive testing and EEG recording sessions take approximately 2-3 hours each. Subjects have the option of stopping at any time. Subjects will also be assessed by clinical rating. Subjects are paid at IRB-approved rates for their participation.
Eligibility: Schizophrenic (DSM-IV) subjects of either sex, aged 18-55, willing to participate in studies. Subjects must not have active drug abuse, previous history of drug addiction, neurological impairments, mental retardation, visual or hearing impairment or other psychiatric disorder. Also, subjects (controls) of either sex, aged 18-55 with no prior or current psychiatric disorder. Control subjects must not have active drug abuse, previous history of drug addiction, neurological impairments, mental retardation or visual or hearing impairment.
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Title: Assessment of Glycine in Schizophrenia
Principal Investigator: Daniel C. Javitt, M.D., Ph.D.
Sites: Bronx Psychiatric Center and Manhattan Psychiatric Center
Contact Person: Gail Silipo, M.A., at (845) 398-6536
Purpose: All current treatments work by blocking the effects of a brain chemical ("neurotransmitter") called dopamine. Dopamine blockers (e.g. haldol, thorazine) improve many of the symptoms of schizophrenia (e.g. hallucinations, paranoia) but fail to improve others. This research focuses on a separate transmitter system, termed the NMDA system. PCP ("phencyclidine, a.k.a. "angel dust") causes schizophrenic-like symptoms by blocking NMDA receptors. This research focuses on development of agents that reverse the effects of PCP. One such compound, glycine, had been found to be safe, well tolerated and clinically effective in previous preliminary studies.
Methods: This research evaluates the effects of glycine in a large sample of inpatients. The entire study takes approximately 18 weeks. Subjects are observed for 4 weeks and then treated with glycine or placebo for 6 weeks in a double-blind fashion. They are then withdrawn from experimental (but not clinical) medication for two weeks and then given the other treatment for 6 weeks. Patients must remain on a fixed dose of neuroleptic throughout the study. Clinical ratings are obtained biweekly and patients are asked to participate in cognitive and EEG testing three times over the course of the study. Blood tests are performed biweekly during the study. Patients are given the opportunity to receive "open label’ glycine at the end of the study. Subjects are paid at IRB-approved rates for cognitive and EEG testing sessions.
Eligibility: Male and non-pregnant female schizophrenic (DSM-IV) subjects age 18-55, who are able to give informed consent and willing to participate in the study. Subjects must have moderate to severe symptoms despite adequate treatment with medication. Subjects must have a normal physical examination. Subjects must not have active drug abuse, previous history of drug addiction, neurological impairments, mental retardation, visual or hearing impairment or other psychiatric disorder.
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Title: Neurochemical Indicators of TD Vulnerability
Principal Investigator: Mary Ann Richardson, Ph.D.
Sites: Rockland Psychiatric Center, St. Agatha Home
Contact Person: Marianne Zarychta, at (845) 398-5516
Description of Research Program: The components of the research program are: A. Invention, development and testing of dietary products that through plasma amino acid regulation can treat movement and psychiatric disorders. B. Experimental studies studying the role of neurotransmitter precursor amino acids in the pathophysiology of movement disorders, psychiatric disorders and addictive substance dependence. Program Director is currently holding NIMH grants in the following areas: a. Placebo-controlled, multiple dose, clinical trial testing for clinical efficacy a product (drink containing a group of three large neutral amino acids) invented by the Program Director to reduce the symptoms of tardive dyskinesia. The clinical sample for this grant is adult men suffering both from psychosis and tardive dyskinesia. b. Open trial of a single dose of the same product being used in adults-testing whether the product can reduce the symptoms of dyskinesias seen in children and adolescents (both male and female) who are currently receiving or have received in the past neuroleptic treatment. c. Genetic studies on enzymes related to metabolism of large neutral amino acids.
Description of Clinical Service: Program Director runs a Regional Movement Disorders Clinic service for the New York State Office of Mental Health . This clinical service program has been in operation since 1988 in junction with Rockland Psychiatric Center. Its functions are to: (1) Evaluate patients for their movement disorder status. (2) Review appropriateness of their treatment regimen for their movement disorder status. (3) Send referring clinician instructive written reports which detail what the particular patient's problem is, how it may relate to the current treatment regimen, and how to best fix it. (4) Continue to monitor the patient for as long it takes to reach the best possible condition.
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The Aging and Dementia Research Center (ADRC), which is a part of the William and Sylvia Silberstein Institute for Aging and Dementia, is a comprehensive clinical research facility at the New York University Medical Center. Please read about their clinical trials below, or visit their web site at http://aging.med.nyu.edu/adrc/index.html
For more information about these pharmaceutical studies, call the Clinical Trials Coordinator, at (212) 263-5708.
Upcoming Studies:
Galantamine for AD: Patients with mild to moderate Alzheimer’s disease will have the opportunity to participate in this study which will test the relative benefits of galantamine and aricept. Subjects will receive either of the two drugs for at least 10 weeks and for as long as 32 weeks. Diagnostic and memory evaluations will be done during that time. Sleeping patterns will also be monitored for 3 separate weeks during the study using a wristwatch-like device that records movements.
Enrollment will begin mid-April.
Aricept for AD: Mild to moderate Alzheimer’s disease patients will have another opportunity to participate in a trial which will study the effects of maintaining Aricept treatment as compared to switching to Galantamine therapy. Subjects will receive either of the two drugs for 12 weeks and visits will be about every other week. Patients must be on Aricept for 3 months prior to being involved in the study. Those who complete the program will receive aricept for 3 months.
Enrollment will begin at the end of May.
For more information about these pharmaceutical studies, call the Clinical Trials Coordinator, at (212) 263-5708.
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