Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
The Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
2 other identifiers
observational
16,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 2, 2001
CompletedFirst Submitted
Initial submission to the registry
September 23, 2001
CompletedFirst Posted
Study publicly available on registry
April 29, 2005
CompletedApril 8, 2026
March 31, 2026
September 23, 2001
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (6)
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
Eligibility Criteria
Individuals being evaluated for mood and anxiety disorders and healthy volunteers
You may qualify if:
- 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.
You may not qualify if:
- Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment, but not including self-help groups).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Suburban Hospitalcollaborator
- National Institute of Mental Health (NIMH)lead
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (6)
Ballard ED, Snider SL, Nugent AC, Luckenbaugh DA, Park L, Zarate CA Jr. Active suicidal ideation during clinical antidepressant trials. Psychiatry Res. 2017 Nov;257:303-308. doi: 10.1016/j.psychres.2017.07.065. Epub 2017 Jul 31.
PMID: 28787656DERIVEDNugent AC, Robinson SE, Coppola R, Zarate CA Jr. Preliminary differences in resting state MEG functional connectivity pre- and post-ketamine in major depressive disorder. Psychiatry Res Neuroimaging. 2016 Aug 30;254:56-66. doi: 10.1016/j.pscychresns.2016.06.006. Epub 2016 Jun 23.
PMID: 27362845DERIVEDBallard ED, Vande Voort JL, Bernert RA, Luckenbaugh DA, Richards EM, Niciu MJ, Furey ML, Duncan WC Jr, Zarate CA Jr. Nocturnal Wakefulness Is Associated With Next-Day Suicidal Ideation in Major Depressive Disorder and Bipolar Disorder. J Clin Psychiatry. 2016 Jun;77(6):825-31. doi: 10.4088/JCP.15m09943.
PMID: 27337418DERIVEDNugent AC, Iadarola ND, Miller FG, Luckenbaugh DA, Zarate CA Jr. Safety of research into severe and treatment-resistant mood disorders: analysis of outcome data from 12 years of clinical trials at the US National Institute of Mental Health. Lancet Psychiatry. 2016 May;3(5):436-42. doi: 10.1016/S2215-0366(16)00006-7. Epub 2016 Mar 10.
PMID: 26971192DERIVEDNugent AC, Robinson SE, Coppola R, Furey ML, Zarate CA Jr. Group differences in MEG-ICA derived resting state networks: Application to major depressive disorder. Neuroimage. 2015 Sep;118:1-12. doi: 10.1016/j.neuroimage.2015.05.051. Epub 2015 May 30.
PMID: 26032890DERIVEDMachado-Vieira R, Yuan P, Brutsche N, DiazGranados N, Luckenbaugh D, Manji HK, Zarate CA Jr. Brain-derived neurotrophic factor and initial antidepressant response to an N-methyl-D-aspartate antagonist. J Clin Psychiatry. 2009 Dec;70(12):1662-6. doi: 10.4088/JCP.08m04659. Epub 2009 Sep 8.
PMID: 19744406DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos A Zarate, M.D.
National Institute of Mental Health (NIMH)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2001
First Posted
April 29, 2005
Study Start
February 2, 2001
Last Updated
April 8, 2026
Record last verified: 2026-03-31
Data Sharing
- IPD Sharing
- Will not share
During the screening process, if a clinical issue arises that warrants further evaluation and/or possible treatment, the subject will be informed and advised to seek medical care in the appropriate setting outside of NIH.