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Protocol Details

A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

95-M-0150

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 55

Referral Letter Required

No

Population Exclusion(s)

Children;
Non-English Speaking;
Pregnant Women and Fetuses

Special Instructions

CALL: Any interested family members can call 1-888-674-6464 and discuss their family situation and learn more about the study during a confidential phone call with the Sibling Study Social Worker.

APPLY: If the study seems suitable for interested siblings, the social worker will mail applications to the family.

FURTHER DISCUSSION WITH FAMILY: There is usually a number of questions that arise and family members are encouraged to call to resolve any questions or concerns that arise.

ACCEPTANCE ESTABLISHED: Once the application material are received and reviewed by the research team, the intake social worker will let the family know whether or not they are accepted.

FAMILY SCHEDULE: The assigned social worker will work with the family to select the week during the year that is most convenient for their participation.

PRE-PAID TRANSPORTATION & LODGING ARRANGED: Once a participation date is set, then transportation and lodging accommodations are arranged. They are pre-paid by NIMH.

GREETED BY NIMH ASSISTANT: NIMH coordinates the transportation to the NIH Clinical Center, Bethesda, MD., where they will be greeted by an assigned staff member. The staff will review the research again with the siblings and answer any remaining questions they might have before they sign the consent form.

TWO DAYS OF PARTICIPATION: The research assistant will introduce the participants to each researcher who will engage them in the research activities that take place in the outpatient clinic.

TRANSPORTATION HOME: Participants complete testing at approximately 3:00 the second day and return home.

PAYMENT: Once the testing is completed, a payment voucher is filled out. The participants will receive their check in the mail.

Keywords

Negative Symptoms;
Brain Scans;
Hallucinations;
Delusions;
Psychosis and Schizophrenia

Recruitment Keyword(s)

None

Condition(s)

Schizoaffective Disorder;
Schizophrenia

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Mental HealthNIH Clinical Center

This large ongoing study at NIMH investigates the neurobiology of schizophrenia by identifying susceptibility genes, evaluating their impact on brain function to better understand how to treat and prevent this illness.

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Eligibility

INCLUSION/EXCLUSION CRITERIA:

Inclusion criteria for Siblings (probands and unaffected siblings):

-Probands must have a DSM IV-R diagnosis of schizophrenia,schizoaffective disorder, psychosis N.O.S. or schizophreniform disorder.

-Probands and Siblings must be between the ages of 18 and 55

-Probands and Siblings must be free of major medical illnesses, but may have controlled hypertension, thyroid disease, or diabetes.

-Probands and Siblings who do not have capacity to provide consent and are under guardianship can participate in the study if the guardian signs the informed consent and the research subject provides their written assent. A DPA is not utilized in this study.

-Fluency in English is required.

Exclusion Criteria for Siblings (probands and unaffected siblings):

-Seizure disorder, mental retardation, organic brain damage or other neurological disease.

-History of any (excepting nicotine-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).

-Cumulative lifetime history of any (excepting nicotine-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5 years total or not in remission for at least 6 months.

-Head trauma with loss of consciousness over 5 minutes from all but genetic sampling.

-Documented metal in the body, e.g. from fixed dental bridges, orthodontia braces, IUDs containing metal or surgical screws.

-Weight and height dimensions that result in size exceeding the capability of the MRI bore circumference is exclusionary.

-Chemotherapy.

-NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy

Siblings who do not qualify for the 2-day or 1-day study, may participate in the limited phenotyping arm in which only a psychiatric interview and a blood draw for genetic analysis (SCID-DNA) will be performed, case control analysis or be included as part of a trio (one parent, one sibling, one patient) to study genetic transmission from parents to offsprings.. All parents are eligible for the study.

Healthy Controls Inclusion Criteria:

To be eligible for this research study, healthy volunteers must be:

-Between the ages of 18 and 55

-Fluency in English is required

Healthy Controls Exclusion Criteria:

They will not be eligible if:

-They have history of DSM IV-R psychiatric diagnosis or severe chronic medical illness at the time of the study.

-They have a history of any (excepting nicotine-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).

-They have a cumulative lifetime history of any (excepting nicotine-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5 years total or not in remission for at least 6 months.

-They may not be eligible for the 2-day or 1-day study if they have a first-degree relative with history of schizophrenia spectrum disorders. However, they may be included in the SCID_DNA or case control analyses..

-Documented presence of metal such as orthodontia braces, surgical screws or IUD of metal composition.

-Healthy volunteers must be free of learning disabilities.

-NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy


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Citations:

Genetic principles and methods in high-risk studies of schizophrenia

Impaired attention, genetics, and the pathology of schizophrenia

Deviant eye tracking in twins discodant for psychosis

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Contacts:

Principal Investigator

Referral Contact

For more information:

Karen F. Berman, M.D.
National Institute of Mental Health (NIMH)



Joann G. Berkson, R.N.
National Institute of Mental Health (NIMH)
National Institutes of Health
Building 10
Room 7-3333
10 Center Drive
Bethesda, Maryland 20892
(301) 451-0167
berksonj@mail.nih.gov

CBDB
National Institutes of Health
Building 10
MSC 1377
Bethesda, Maryland 20892
(888) 674-6464
schizophrenia@intra.nimh.nih.gov

Clinical Trials Number:

NCT00001486

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