Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers
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| First Received Date ICMJE | September 23, 2001 | ||||||||
| Last Updated Date | December 19, 2012 | ||||||||
| Start Date ICMJE | September 2001 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00024635 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers | ||||||||
| Official Title ICMJE | 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 volunteers for participation in research protocols in the Mood and Anxiety Disorders Program (MAP) 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); electroencephalography (EEG); magnetoencephalography (MEG); blood 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 MAP protocols. |
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| Detailed Description | 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. 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); 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 ETPB protocols. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Not Provided | ||||||||
| Study Population | Not Provided | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 16000 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE |
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. |
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| Gender | Both | ||||||||
| Ages | 3 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00024635 | ||||||||
| Other Study ID Numbers ICMJE | 010254, 01-M-0254 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Suburban Hospital | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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