NCT06776848View on ClinicalTrials.gov

A Placebo-controlled Evaluation of Low Dose Lithium Carbonate in Patients With TBR1-related Neurocognitive Disorders

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 12, 2025

Primary Completion Date

September 12, 2027

Study Completion Date

September 12, 2027

Conditions
Proven Pathogenic or Probably Pathogenic TBR1 Variant
Interventions
OTHER

Observation phase

Start of the observation phase for all patients for a period of 6 months. Group B: continuation of the observation phase for a further 6 months

DRUG

Lithium treatment

The daily dose of lithium will be increased until the target lithiaemia is reached, while monitoring tolerance and possible adverse effects.

BIOLOGICAL

biological monitoring

"The blood level of lithium will be monitored by regular blood tests~\- every 4 days until a targeted blood level is obtained"

Trial Locations (1)

21000

RECRUITING

CHU Dijon Bourgogne, Dijon

All Listed Sponsors
lead

Centre Hospitalier Universitaire Dijon

OTHER

NCT06776848 - A Placebo-controlled Evaluation of Low Dose Lithium Carbonate in Patients With TBR1-related Neurocognitive Disorders | Biotech Hunter | Biotech Hunter