Lithium treatment for children with autism

Lithium treatment for children with autism: A randomized, controlled, phase II trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000040336

Enrollment

Unknown

Registered

2020-11-28

Start date

2020-12-01

Completion date

Unknown

Last updated

2021-02-16

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

Conditions

Autism spectrum disorder

Interventions

experimental group:Lithium carbonate

Control group:calcium carbonate

Eligibility

Sex/Gender

All

Age

3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Meet the ASD diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, age 3-12 years; 2. Behavior Scale for children with autism (ABC) more than 53 points; 3. Children autism rating scale (CARS)>30 points; 4. The family members give informed consent and sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Genetic metabolic disease; 2. Chromosomal diseases; 3. Epilepsy; 4. History of high fever and convulsion; 5. Have taken any drugs that can cause cognitive change and damage to organs within 1 month; 6. Any other physical or mental disorder that can cause brain dysfunction.

Design outcomes

Primary

Measure	Time frame
Autism Treatment Evaluation Checklist, ATEC;	—

Secondary

Measure	Time frame
Autism Behavior Checklist, ABC;Childhood Autism Rating Scale, CARS;Psychoeducational Profile version 3, PEP-3;The Children Sleep Health Questionnaire, CSHQ;Gastrointestinal assessment questionnaires (GSRS);Hippocampal volume;Parenting Stress Index-Short Form PSI-SF;	—

Countries

China

Contacts

Public ContactChanglian Zhu

The Third Affiliated Hospital of Zhengzhou University

zhuc@zzu.edu.cn+86 13526520357

Outcome results

None listed

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