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View Clinical Trial (Medical Research Study)

Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers - NCT00024635-20892 (Clinical Trial 403559)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy403559.aspx



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City:  Bethesda
State:  
MD
Zip Code: 20892
Conditions: Mood Disorder - Anxiety Disorder
Purpose: The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Mood and Anxiety Disorders Program (MAP) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); electroencephalography (EEG); magnetoencephalography (MEG); blood and urine laboratory evaluation; and a request for medical records. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved MAP protocols....
Study summary: The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Mood and Anxiety Disorders Program (MAP) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. Subjects in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain magnetic resonance imaging (MRI); electroencephalography (EEG); magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request for medical records. The data collected may also be linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA, psychophysiology tests, treatment studies, etc) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents of minors will be interviewed. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The current protocol thus serves as an entry point for individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved MAP protocols.
Criteria: - INCLUSION CRITERIA: Subjects must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols. Minors will be asked to assent and their parents will sign the consent form. Subjects will undergo an evaluation which may include a psychiatric interview, medical (including Tanner staging for minors), neurological, and laboratory examinations (as appropriate such as EKG, EEG, renal and liver function tests, serum electrolytes, urinalysis, HIV, hepatitis A, B, and C, blood levels of psychotropic drugs, pregnancy testing, and urine drug screen for the presence of psychoactive drugs and drugs of abuse). EXCLUSION CRITERIA: Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder or anxiety disorder). Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups). Whether the minor lives with both parents or one parent, the parent(s) he/she lives with must have legal custody. If a parent has shared custody, both parents must consent to participate in this protocol.
Study is available at: National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States

Primary Contact:
Brenda Y. Gray
Email: moodresearch@mail.nih.gov
Phone: (877) 646-3644
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 15, 2010
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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.


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