Protocol Number: 01-M-0254

Title:

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

Number:

01-M-0254

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 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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility 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.

Special Instructions:

Currently Not Provided

Keywords:

Screening

Psychiatric History

Medical History

Diagnostic Evaluation

Physical Examination

Mood

Anxiety

Diagnostic Testing

Recruitment Keyword(s):

Anxiety

HV

Healthy Volunteer

Normal Control

Mood Disorder

PTSD

Post-Traumatic Stress Disorder

Condition(s):

Mood Disorder

Anxiety Disorder

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Mental Health

Contact(s):

Brenda Y. Gray
National Institutes of Health
Building 10
Room 3N228
10 Center Drive
Bethesda, Maryland 20892
Phone: (877) 646-3644
Fax: Not Listed
Electronic Address: moodresearch@mail.nih.gov

Citation(s):

The Yale-Brown Obsessive Compulsive Scale I Development, use, and reliability

A rating scale for mania: reliability, validity and sensitivity

Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL):initial reliability and validity data

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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/16/2008