This protocol is designed to screen candidates for participation in research studies in the National Institute of Mental Health's Mood and Anxiety Disorders Program (MAP). Participants must meet the specific criteria of a research study; this protocol serves as an entry point for admitting eligible patients and healthy volunteers to a MAP study.

Adults and children with mood and anxiety disorders and healthy volunteers may be eligible for this screening protocol. Evaluations vary for different protocols. Depending on the study of interest, candidates may undergo some or all of the following procedures: diagnostic interview; mood ratings, anxiety ratings, functioning ratings, other ratings; neuropsychological testing, physical examination; blood and urine tests, which may include a screen for drug abuse, tests for hepatitis, HIV, chemistry, blood count, thyroid function, pregnancy, and medication levels; and personal, social and family histories.

Healthy volunteers will be screened on an outpatient basis. Individuals with mood and anxiety disorders may be evaluated on an inpatient or outpatient basis. Outpatient screening involves one to three clinic visits of 1 to 4 hours over the course of 1 to 4 weeks. Inpatient screening may take from 1 to 3 weeks. If medical or psychiatric problems arise during inpatient evaluation, short-term treatment will be provided. Long-term treatment and psychotherapy are not offered under this screening protocol.

Condition
Mood Disorder Anxiety Disorder

Further Study Details: 

Expected Total Enrollment:  16000

The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers in order to determine if the patient/volunteer is appropriate for participation in research protocols in the Mood and Anxiety Disorders Program (MAP) at the National Institute of Mental Health (NIMH). 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; blood and urine laboratory evaluation; and a request for medical records. 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.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00024635

Maryland
      National Institute of Mental Health (NIMH), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  010254; 01-M-0254
Record last reviewed:  September 17, 2004
Last Updated:  April 28, 2005
Record first received:  September 23, 2001
ClinicalTrials.gov Identifier:  NCT00024635
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03