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The role and mechanism of lithium salt in children with ADHD

The role and mechanism of lithium salt in children with ADHD

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089288
Enrollment
Unknown
Registered
2024-09-05
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

hyperactivity

Interventions

Experimental group:Oral lithium extended-release treatment, 5 mg/kg, twice daily, 12 hours apart, for 3 months, discontinued for 3 months.
Control group 1:Administered oral placebo calcium carbonate based on conventional rehabilitation training
Control group 2:Only receive treatment with methylphenidate
Combination therapy group:Treatment with methylphenidate in addition to oral lithium extended-release

Sponsors

Zhengzhou University Third Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: Children aged 6 to 14 years with a definite diagnosis of ADHD were included if they were 1) aged 6 to 14 years inclusive at the time of parental informed consent; 2) male or female; 3) had a DSM-V confirmed diagnosis of ADHD (any manifestation) at screening and were determined by SNAP-IV; 4) were not receiving medication with methylphenidate or amphetamines at that time; or were receiving medication and had to be willing and appropriate (ie, receive the best treatment at the investigator 's discretion) to washout current treatment regimen.

Exclusion criteria

Exclusion criteria: Exclusion criteria : 1) Patients who are currently receiving non-stimulant drugs for ADHD (i.e. atomoxetine, clonidine, guanfacine, etc.); 2) Complications of inherited metabolic diseases or autoimmune/inflammatory diseases; 3) Epilepsy; 4) History of febrile convulsions, fever or other infectious symptoms; 5) Taking any drug that can cause cognitive changes and important organ damage within 1 month before medication; 6) Any other physical and mental disorders that can lead to brain dysfunction

Design outcomes

Primary

MeasureTime frame
Near Infrared Functional Brain Imaging;ADHD-RS;IVA;SNAP-IV;

Secondary

MeasureTime frame
Electroencephalogram;Weiss;Conners;Intelligence assessment (Wechsler);S-S;QCD;PRS;PSI;

Countries

China

Contacts

Public Contactchanglian zhu; Yiran Xu

Zhengzhou University Third Affiliated Hospital

changlianzhu@hotmail.com+86 135 2652 0357

Outcome results

None listed

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