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Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00024635
Recruitment Status : Recruiting
First Posted : April 29, 2005
Last Update Posted : May 23, 2023
Sponsor:
Collaborator:
Suburban Hospital
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Description
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Brief 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 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.

Condition or disease
Mood Disorders Anxiety Disorders Healthy Volunteers Bipolar Disorder Depression

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 16000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
Actual Study Start Date : February 2, 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Groups and Cohorts
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Group/Cohort
Adult Healthy Volunteers
Adult Healthy Volunteers
Adult Patients
Adult patients with mood and anxiety disorders
Minor Healthy Volunteers
Minor Healthy Volunteers
Minor Patients
Minor patients with mood and anxiety disorders
Parents of Minor Healthy Volunteers
Parents and guardians of minor healthy volunteers
Parents of Minor Patients
Parents and guardians of minor patients with mood and anxiety disorders


Outcome Measures
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Primary Outcome Measures :
  1. Eligibility for research [ Time Frame: Current and historical ]
    Evaluations of psychiatric and other medical conditions and histories to determine if the subjects are appropriate for participation in NIMH IRB approved protocols and for the collection of natural history data.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals being evaluated for mood and anxiety disorders and healthy volunteers
Criteria
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024635


Contacts
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Contact: Carlos A Zarate, M.D. (877) 646-3644 moodresearch@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Suburban Hospital
Investigators
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Principal Investigator: Carlos A Zarate, M.D. National Institute of Mental Health (NIMH)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00024635    
Other Study ID Numbers: 010254
01-M-0254
First Posted: April 29, 2005    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: April 13, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: .During the screening process, if a clinical issue arises that warrants further evaluation and/or possible treatment, the subject will be informed and advised to seek medical care in the appropriate setting outside of NIH.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Screening
Anxiety
Mood
Diagnostic Testing
Natural History
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Bipolar Disorder
Mood Disorders
 Pathologic Processes
Mental Disorders
Bipolar and Related Disorders