Bumetanide for Autism Treatment Study
- Conditions
- Autism Spectrum DisorderTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2014-001560-35-NL
- Lead Sponsor
- Brain Center Rudolf Magnus, University Medical Center Utrecht, Department of Psychiatry, Utrecht , the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method