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Investigation of the cause of autism using the medication Bumetanide

Testing E/I imbalance in autism with Bumetanide – a parallel group randomized waitlist-control trial in adolescents and adults - Testing E/I imbalance in autism with Bumetanide

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2021-003514-39-SE
Enrollment
50
Registered
2021-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Interventions

Sponsors

Gillberg Neuropsychiatry Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Autism Spectrum Disorder Age 12-40 years old. Are the trial subjects under 18? yes Number of subjects for this age range: 25 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Long QT syndrome Intellectual disability

Design outcomes

Primary

MeasureTime frame
Main Objective: To test the Excitatory/Inhibitory (E/I) imbalance hypothesis of the underlying neurophysiology in Autism Spectrum Disorder, by testing the effect of the diuretic drug Bumetanide on objectively measured performances and physiological reactions to specific socio-emotional and perceptual tests. ;Secondary Objective: To test the safety and tolerability of the drug in Autism Spectrum Disorder. ;Primary end point(s): Improvement in emotion labeling task;Timepoint(s) of evaluation of this end point: Baseline, at 3 months and at 6 months

Secondary

MeasureTime frame
Secondary end point(s): Change in pupillary reaction to emotional faces Change in results in paradoxical motion perception task Change in attention to details Change in fear detection task Change in sensory perception Type of AE, SAEs, SUSARs Frequency of AE, SAEs, SUSARs Severity of AEs, SAEs ;Timepoint(s) of evaluation of this end point: Baseline, at 3 months and at 6 months. Safety endpoints regarding adverse events will be estimated at each contact with subjects.

Countries

Sweden

Contacts

Public ContactGNC

Gillberg Neuropsychiatry Centre

nouchine.hadjikhani@gnc.gu.se00460313425986

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026