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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 23, 2001 | ||||||||
| Last Updated Date | August 28, 2009 | ||||||||
| Start Date ICMJE | September 2001 | ||||||||
| Estimated Primary Completion Date | April 2002 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
To estimate the MTD of oral CC-5013 administered to children with recurrent or refractory primary CNS tumors once daily for 21 days of a 28 day course. | ||||||||
| Change History | Complete list of historical versions of study NCT00024635 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
To characterize the pharmacokinetics of CC-5013 in children and adolescents. | ||||||||
| 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 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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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 16000 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | April 2002 (final data collection date for primary outcome measure) | ||||||||
| 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 ID ICMJE | NCT00024635 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 010254, 01-M-0254 | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | August 2009 | ||||||||
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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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