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Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers

Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers

Recruiting
3-99 years
All
Phase N/A

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Overview

The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols in the Experimental Therapeutics and Pathophysiology Lab (ETPB) at the National Institute of Mental Health (NIMH) and for the collection of natural history data. In addition the protocol will allow clinicians to gain more experience in the use of a variety of polysomnographic and high-density EEG recordings. 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); electrocardiography (EKG), magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request for medical records. Subjects may also be asked to complete questionnaires about attitudes towards research and motivation for research participation. 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 ETPB protocols.

Description

The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols on mood and anxiety disorders 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); computed tomography (CT); electroencephalography (EEG); electrocardiography (EKG), 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 protocols.

Eligibility

  • INCLUSION CRITERIA:

Subjects ages 3 to 99 may enroll in the protocol.

        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 details
    Mood Disorders
    Anxiety Disorders
    Healthy Volunteers
    Bipolar Disorder
    Depression

NCT00024635

National Institute of Mental Health (NIMH)

11 June 2024

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