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Bumetanide for Autism Treatment Study

Phase 1
Conditions
Autism Spectrum Disorder
Therapeutic 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
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.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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