FASST - Fetal Alcohol Spectrum Stimulant Trial

PHASE4UnknownINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 14, 2022

Primary Completion Date

April 30, 2023

Study Completion Date

July 31, 2023

Conditions
Fetal Alcohol Spectrum Disorders
Interventions
DRUG

Methylphenidate Hydrochloride

This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Ritalin 10 will be administered at the child's prescribed dose and may include a half tablet (5mg) increment. Ritalin 10 will be encapsulated in full tablet (10mg) or half tablet (5mg) dose.

DRUG

Placebo

The placebo is Maize Starch and Pregelatinised Maize Starch. The placebo will be encapsulated using the same capsule that is opaque so that participants cannot distinguish the two visually. Where the active mediation amount is small for the capsule, there will be additional Starcke 1500 (Maize Starch and Pregelatinised Maize Starch) added to fill the capsule so that the active drug and capsule also weigh approximately the same. The dose of placebo will be matched to the participants currently prescribed stimulant medication.

DRUG

Methylphenidate hydrochloride

This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Ritalin LA will be administered at the child's prescribed total dose. Ritalin LA will be encapsulated.

DRUG

Methylphenidate Hydrochloride 18 MG

This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Concerta (18mg) will be administered at the child's prescribed total dose. Concerta will be encapsulated.

DRUG

Dexamphetamine sulfate

This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Dexamphetamine (10mg) will be administered at the child's prescribed total dose. Dexamphetamine will be encapsulated.

Trial Locations (1)

3168

RECRUITING

Monash Health, Clayton

Sponsors
All Listed Sponsors
collaborator

Monash University

OTHER

lead

Monash Medical Centre

OTHER