Bumetanide in Autism Medication and Biomarker study<br>

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

1. Males or females aged *7 years to *15 years;
2. Criteria met for autism spectrum disorder and on DSM-V Social Responsiveness Scale (SRS) (24).
3. Written informed consent.

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 and blood sampling to control diuretic effects.
2. Serious, unstable illnesses including, gastroenterologic, respiratory, cardiovascular (arythmias, QT interval lengthening), endocrinologic, immunologic, hematologic disease, dehydration or hypotension;
3. Renal insufficiency (CKD st2-5; estimated glomerular filtration rate < 90 ml/min/1.73m2), congential or acquired renal disease with decreased concentration capacity (tubulopathy, diabetes insipidus) and liverinsufficiency interfering with excretion or metabolism of Bumetanide;
4. Neurological disorders such as epilepsy, seizures and microcephaly;
5. Start of behavioral treatment during study
6. Treatment with psychoactive medications (antipsychotics, antidepressants, anxiolytic drugs, psychostimulant drugs or other medication with effect on the central nervous system, including anti-epileptic drugs) 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, aminoglycosides, digitals, antihypertensive agents, indomethacin, probenecid, Lithium, other diuretics (e.g. furosemide, hydrochlorothiazide), drugs known to have a nephrotoxic potential
8. Documented history of hypersensitivity reaction to sulfonamide derivatives.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints will be the change in score on Social Responsiveness Scale<br /><br>(SRS). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will involve adaptive skill assessments; behavioral<br /><br>symptoms relating to rigidity; sensory modulation profiles , resting state EEG,<br /><br>sensory evoked EEG paradigms (ERP) and genetic analysis to predict treatment<br /><br>response. </p><br>