Depression Clinical Trial in Bethesda MD
NCT00024635
| Observational
This study is looking to recruit 16000 Participants
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.
Details for the study
Population
Individuals being evaluated for mood and anxiety disorders and healthy volunteers
Brief Title
Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
Official Title
The Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
Brief Summary
The purpose of this protocol is to allow for the careful screening of patients and healthy
<br /> volunteers for participation in research protocols in the Experimental Therapeutics and
<br /> Pathophysiology Lab (ETPB) at the National Institute of Mental Health (NIMH) and for the
<br /> collection of natural history data. In addition the protocol will allow clinicians to gain
<br /> more experience in the use of a variety of polysomnographic and high-density EEG recordings.
<br /> Subjects in this protocol will undergo an evaluation which may include: a psychiatric
<br /> interview; a diagnostic interview; rating scales; a medical history; a physical exam; brain
<br /> magnetic resonance imaging (MRI); electroencephalography (EEG); electrocardiography (EKG),
<br /> magnetoencephalography (MEG); blood, saliva and urine laboratory evaluation; and a request
<br /> for medical records. Subjects may also be asked to complete questionnaires about attitudes
<br /> towards research and motivation for research participation. The data collected may also be
<br /> linked with data from other mood and anxiety disorder protocols (e.g., brain imaging, DNA,
<br /> psychophysiology tests, treatment studies, etc) for the purposes of better understanding the
<br /> diagnosis, pathophysiology, and treatment response of patients with mood disorders. Parents
<br /> of minors will be interviewed. Upon conclusion of the screening process, subjects will either
<br /> be offered participation in a research protocol and will sign the appropriate informed
<br /> consent, or will be considered not appropriate for participation in research and will be
<br /> referred back into the community. The current protocol thus serves as an entry point for
<br /> individuals with mood or anxiety disorders or healthy volunteers to enter NIMH IRB approved
<br /> ETPB protocols.
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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
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.
Study 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.