Genetic Aspects of Neurologic and Psychiatric Disorders
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||April 1996|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001544 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Genetic Aspects of Neurologic and Psychiatric Disorders|
|Official Title ICMJE||Genetic Aspects of Neurologic and Psychiatric Disorders|
The purpose of this study is to improve the understanding of the genetic causes of specific neurologic and psychiatric disorders. The study will focus on conditions of mental retardation, childhood onset schizophrenia, attention deficit hyperactivity disorder (ADHD), atypical psychosis of childhood, and bipolar affective disorder.
The study addresses the belief that there may be several genes contributing to the illness. Researchers intend to use several molecular genetic techniques in order to identify the areas of chromosomes containing genes responsible for the development of these disorders.
Patients will be selected to participate in this study based on an early age of onset of their condition as well as the severity of the illness and the frequency of the illness among family members. Researchers will collect DNA samples from patients as well as affected and unaffected family members of each patient. The DNA samples collected will be analyzed for a variety of genetic abnormalities including; triplet repeat expansions, chromosome rearrangements, and polymorphisms.
We propose to use DNA probes to study patients having specific neurologic and psychiatric disorders, especially focusing on patients with early onset or extreme phenotypes such as childhood onset schizophrenia (COS), mental retardation (MR), attention deficit hyperactivity disorder (ADHD), atypical psychosis of childhood, (multi-dimensional impairment MDI), and bipolar affective disorder (BPAD). This study addresses the hypothesis that genetic risk factors contribute to these diverse phenotypes. Several complementary molecular genetic techniques are employed to identify chromosomal regions containing genes contributing to specific neurologic and psychiatric disorders. Patients will be selected for this study on the basis of the age of onset and severity of neurologic or psychiatric symptoms, familial genetic loading and family structure. Individuals participating in this protocol will be clinically evaluated through other NIMH or NIH clinical protocols, particularly through those of the Child Psychiatry Branch (reference protocol numbers 85-M-0115, 84-M-0050, 97-M-0126). Those subjects meeting inclusion criteria may undergo a screening that may include physical, neurologic or psychiatric examinations. As appropriate, this initial screen may be followed by more formal, structured instruments such as the Schedule for Affective Disorders (SADS), the revised Weschler Adult Intelligence Scale (WAIS-R), the Conner's revised parent and teacher ratings, and the Diagnostic Interview for Children and Adolescents (DICA- version IV) to confirm the clinical diagnosis at the discretion of the treating physician. Venipuncture and/or buccal swabs will be performed in order to obtain samples for DNA extraction or to establish a lymphoblast cell line to be used in genetic tests. Samples will also be collected from family members and controls for these studies.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Individuals with selected psychiatric and neurologic disorders, including childhood onset schizophrenia, atypical psychosis, mental retardation, bipolar affective disorder, and ADHD.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001544|
|Other Study ID Numbers ICMJE||960060, 96-M-0060|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Mental Health (NIMH)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2004|
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