- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00024635
Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
The Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Carlos A Zarate, M.D.
- Phone Number: (877) 646-3644
- Email: moodresearch@mail.nih.gov
Study Locations
-
-
Maryland
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Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
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Adult Healthy Volunteers
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Adult Patients
Adult patients with mood and anxiety disorders
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Minor Healthy Volunteers
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Minor Patients
Minor patients with mood and anxiety disorders
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Parents of Minor Healthy Volunteers
Parents and guardians of minor healthy volunteers
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Parents of Minor Patients
Parents and guardians of minor patients with mood and anxiety disorders
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eligibility for research
Time Frame: Current and historical
|
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
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carlos A Zarate, M.D., National Institute of Mental Health (NIMH)
Publications and helpful links
General Publications
- 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.
- Nugent 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.
- Ballard 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. Erratum In: J Clin Psychiatry. 2016 Dec;77(12):e1655.
- Nugent 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.
- Nugent 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.
- Machado-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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010254
- 01-M-0254
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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