Patient Volunteers

INPATIENT INVESTIGATIONAL RESEARCH STUDIES

CURRENT STUDIES ON THE TREATMENT RESEARCH UNIT

Olanzapine vs Clozapine in Treatment-Resistant Schizophrenia

In an attempt to understand how clozapine works and why it is more effective, olanzapine will be compared to clozapine in this study. In a previous study, treatment resistant patients who responded favorably to olanzapine tended to have higher blood levels than those who did not. Therefore a higher dose of olanzapine (50mg) will be compared to clozaril (450mg). Additionally, brain imaging (MRI/PET) may be used in an attempt to find similarities and differences in the way the medications are utilized in the different parts of the brain.

New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment-Resistant Schizophrenia

The purpose of this study is to evaluate the efficacy and safety of the
new antipsychotics, quetiapine and risperidone compared to each other and to fluphenazine. These medications will be evaluated for their effectiveness in the treatment of hostility and aggression, in outcomes such as discharge, quality of life, independent living and sexual functioning, and their impact on cognition and prolactin levels.

General Criteria:

• Males or Females between 18 and 65 years of age
• Diagnosis of schizophrenia or schizoaffective disorder
• Persistent psychotic symptoms while taking anti-psychotic medication
• Able to understand and voluntarily consent to program requirements
• Medically stable

Referral Information:

Stephanie Feldman LCSW-C, 410-402-6885 or sfeldman@mprc.umaryland.edu

CURRENT STUDIES ON THE RESIDENTIAL RESEARCH UNIT

New Treatment Protocols

An 8-week medication trial that examines the effectiveness of an anti-psychotic (neuroleptic) medication in treating the symptoms of schizophrenia. It is a randomized study where some participants may receive placebo (non-active medication). However, all participants are maintained on a low dose of Haldol throughout their study participation.

A 52-day medication trial that examines the effectiveness of another new anti-psychotic (neuroleptic) medication in treating the symptoms of schizophrenia. This is a randomized study where some patients may receive placebo (non-active medication). The new medication is expected to reduce psychotic symptoms without causing movement side effects. Patients in this study must have a diagnosis of schizophrenia and women of chilbearing potential are excluded.

Time Course PET Studies with Neuroleptic Medication

The purpose of these studies is to examine the effects of single doses of anti-psychotic medications on the cerebral blood flow over a period of 50 hours. By studying the brain regions where the medications work, it may be possible to learn exactly which areas of the brain are involved in schizophrenia.

Auditory Task PET Scans on/off Neuroleptic Medication

This study compares differences in cerebral blood flow between stable treatment with neuroleptic medication and being medication-free. Participants are asked to listen to tones during the PET scans in order to control the study condition. The purpose of the study is to identify brain regions that may be involved in schizophrenia by examining the effects of treatment with neuroleptic medication.

General Criteria:

• Males or Females between 18 and 55 years of age
• Diagnosis of schizophrenia, schizoaffective disorder or a chronic psychotic disorder
• Residents of the State of Maryland
• Medically stable
• Able to understand and voluntarily consent to program requirements

For more information, contact:

Anne Donohue, LCSW-C, 410-402-6843 or adonohue@mprc.umaryland.edu

OUTPATIENT INVESTIGATIONAL RESEARCH STUDIES

Glutamatergic Agents for the Tx of Negative Symptoms and Cognitive Impairments

In this study, we are testing two agents, d-cycloserine and glycine, to determine the effectiveness of the drugs, in the treatment of negative symptoms and cognitive impairments. D-cycloserine is approved by the FDA as an antibiotic treatment of bacterial infections. Glycine is an amino acid, which is available as an over the counter nutritional supplement.

Basic Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder
• Age 18-64
• Persistent moderate to severe negative symptoms.

These symptoms include:

• trouble talking
• difficulty expressing emotions
• lack of motivation
• social isolation
• problems with memory
• trouble paying attention
• difficulty solving problems
• not currently taking clozapine
• other criteria apply

For further information, please contact:

Michelle Eberhardt, Intake Coordinator, at 410-402-7469 or meberhar@mprc.umaryland.edu

Adjunctive Resperidone in Clozapine-Treated Patients

The primary goal of this study is to examine whether or not the addition of risperidone to clozapine will have a beneficial effect on persistent positive symptoms and cognitive impairments.

Basic Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder
  Age 18-65
• Currently on clozapine at a therapeutic level (400mg) for six months or more
• Other criteria apply.

For further information, please contact:

Michelle Eberhardt, Intake Coordinator, at 410-402-7469 or meberhar@mprc.umaryland.edu

Adjunctive Galantamine for Cognitive Impairments

Galantamine has been shown to improve cognitive function in patients with Alzheimer's disease. There is preliminary evidence that galantamine may improve cognitive function in patients with schizophrenia, while decreasing positive symptoms. This study adds galantamine or placebo to patients' usual medication regimens to measure galantamine's effect on cognition and positive symptoms.

Basic Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder
  Age 18-60
• Currently treated with zyprexa (olanzapine), resperdal (risperidone), seroquel (quetiapine), or geodon (ziprasidone).
• Other criteria apply.

For further information, please contact:

Michelle Eberhardt, Intake Coordinator, 410-402-7469 or meberhar@mprc.umaryland.edu

Olanzapine in the Treatment of Tardive Dyskinesia

This project involves a 52-week use of either Olanzapine or of Haldol, followed by a subsequent year of Olanzapine treatment. Our hypothesis is that Olanzapine will allow for gradual reversal of pre-existing tardive dyskinesia. Clinical care, medications, and door-to-door transportation is provided free of cost. No payment is provided to the patient.

To be eligible you must:

• Have tardive dyskinesia (jerking or twitching movement as a side effect from antipsychotic medications).
• Have a diagnosis of schizophrenia or schizoaffective disorder.
• Be between the ages of 18 and 65.

To refer someone call:

Helene Adami, LCSW-C, 410-402-6832 or hadami@mprc.umaryland.edu

Family Study in Schizophrenia

It has been noted for years that people with schizophrenia often move their eyes differently than the population at large. These subtle but characteristic movements can not be observed by the naked eye, but only with the use of computer eye-tracking equipment in a laboratory. Our clinic needs family members of people with schizophrenia to volunteer to do these eye movement tests (as well as neuropsychological testing and clinical interviews) in order for us to further our understanding of what these movements may, or may not, mean. Our full range of testing takes about 16 hours (over the course of two or more visits). Compensation will be provided for your time

To be eligible you must:

• Be an immediate family member (parent, child, or sibling) of someone who has schizophrenia or schizoaffective disorder.
• Not currently taking psychiatric medications.

To refer someone call:

Helene Adami, LCSW-C, 410-402-6832 or hadami@mprc.umaryland.edu

Early Intervention in Schizophrenia

This program is designed to serve people who have recently developed a psychotic illness. Newly ill patients pose a special challenge in treatment settings, as they frequently have poor insight and poor medication compliance, leading to frequent re-hospitalizations. The families of newly ill patients are often in turmoil; unsure of what's going on, and unsure of how best to live and work with their loved one. Our clinic's purpose is to deal with such issues by working intensively with the individuals and their families. With a low staff to patient ratio, we are able to effectively provide education about the illness, provide medications and therapy, and to link patients with the resources they may need (housing, insurance, etc).

To be eligible you must:

• Have developed signs of psychosis (or early warning signs) within the last 18 months.
• Have been ill longer, but have 18 months or less of neuroleptic exposure.

To refer someone call:

Helene Adami, LCSW-C, 410-402-6832 or hadami@mprc.umaryland.edu

Children at High Risk for Schizophrenia

Relatives of persons with schizophrenia are known to be at a substantially higher risk of developing the illness than is the population at large. Abnormal eye-tracking is thought to be a possible marker of vulnerability to schizophrenia. In this new project we hope to recruit and eye-track children who are related to a person with schizophrenia and then follow their course over the years. It is hoped that this long term project may shed light on the question of whether vulnerability to schizophrenia can be identified early in life. If this is so, perhaps early interventions can be developed which minimize this risk. Testing takes 5-8 hours in all; compensation will be provided for your time.

Refer:

Children and young people, ages 18 and less, who are the child or sibling of a person with schizophrenia. We will, of course, initially talk with the child's parent or guardian to explain the process and answer any questions they may have. Transportation and payment is provided.

To refer someone call:

Helene Adami, LCSW-C at 410-402-6832 or hadami@mprc.umaryland.edu

NON-PATIENT VOLUNTEERS NEEDED

The Maryland Psychiatric Research Center is looking for volunteers to participate in various research studies, including interviews and physiological studies such as eye movement measures. Volunteers should be between the ages of 21-45. Compensation will be provided for your time. This initial study may take 4-6 hours to complete. You may also qualify to participate in other studies, if you are interested. This can include neuropsychological testing, investigational medication studies, experimental and conventional brain scanning and brain wave records. If you are interested in learning more about becoming a research volunteer, call the MPRC at (410) 402-6825 or (410) 402-6820.