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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 99
Healthy Volunteers: t
View:

• 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, lupus anticoagulant, anticardiolipin (aCL) antibodies, anti-b2glycoprotein-I antibodies, PT/PTT, blood levels of psychotropic drugs, pregnancy testing, and urine drug screen for the presence of psychoactive drugs and drugs of abuse).

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Carlos A Zarate, M.D.
moodresearch@mail.nih.gov
(301) 326-5836
Time Frame
Start Date: 2001-02-02
Participants
Target number of participants: 16000
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: National Institute of Mental Health (NIMH)
Collaborators: Suburban Hospital

This content was sourced from clinicaltrials.gov