EUCTR2014-001560-35-NL
Active, not recruiting
Phase 1
Bumetanide in Autism Medication and BIomarker study - BAMBI
Brain Center Rudolf Magnus, University Medical Center Utrecht, Department of Psychiatry, Utrecht , the Netherlands0 sitesJanuary 13, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Brain Center Rudolf Magnus, University Medical Center Utrecht, Department of Psychiatry, Utrecht , the Netherlands
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Males or females aged \=7 years to \=15 years;
- •2\.Criteria met for autism on Autism Diagnostic Observation Schedule \- Generic (ADOS G) and Social Responsiveness Scale (SRS) (24\).
- •3\.Written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Total IQ \< 55 (WISC) and/or inability to comply with the protocol\-specified procedures for the duration of the study, including treatment, blood sampling to control diuretic effects.
- •2\.Serious, unstable illnesses including, gastroenterologic, respiratory, cardiovascular (QT interval lengthening), endocrinologic, immunologic, or hematologic disease;
- •3\.Renal or hepatic dysfunction that would interfere with excretion or metabolism of Bumetanide;
- •4\.Neurological disorders such as epilepsy, seizures and microcephaly;
- •5\.Behavioral treatment
- •6\.Treatment with psychoactive medications, including anticonvulsants, in the last 8 weeks prior to start of the study, except melatonin; no use of other psychoactive substances is allowed from 8 weeks prior to the pre\-study evaluation until the endpoint measurements at the end of the washout period. If clinically feasible and desired by the patients and/or parents, then it is allowed to stop psychoactive medication to allow enrollment in the study after a 8 week washout period of their psychoactive medication.
- •7\.Treatment with NSAIDS or aminoglycosides.
- •8\.Documented history of hypersensitivity reaction to sulfonamide derivatives.
Outcomes
Primary Outcomes
Not specified
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