Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers

Depression Clinical Trial

Official title:

The Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00024635
• Other study ID #: 010254
• Secondary ID: 01-M-0254
• Status: Recruiting
• Start date: February 2, 2001

Study information

• Verified date: April 16, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Carlos A Zarate, M.D.
• Phone: (877) 646-3644
• Email: moodresearch[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 99 Years

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Disorder
• Depression
• Healthy Volunteers
• Mood Disorders

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)	Suburban Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eligibility for research	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.	Current and historical

External Links

•   NIH Clinical Center Detailed Web Page