Effects of Methylphenidate on Brain and Cognition in 22q11 Deletion Syndrome

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Chromosome 22q11.2 deletion syndrome (22q11DS) is a neurogenetic condition associated with a high risk of psychiatric disorders, including schizophrenia spectrum disorders. This population is characterized by a specific neurocognitive profile and atypical brain development. Methylphenidate is a psychostimulant used in the treatment of attention deficit with/without hyperactivity (ADHD). Although ADHD is one of the most important co-morbidities in 22q11DS, affecting 35-45% of patients, to date only two studies have focused on quantifying the efficacy of this treatment in this population. The objective of this study is to quantify the improvement in cognitive performance as well as the differences in brain connectivity associated with the methylphenidate molecule in a population at risk of cognitive impairment and the development of schizophrenia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Geneva, Switzerland
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Male or female with confirmed 22q11DS diagnosis.

• Minimum age of 8 years or maximum age of 25 years and 11 months.

• Attention difficulties pointed out by parents and/or the participant.

• Sufficient verbal expression and comprehension skills to understand and follow instructions based on initial interview.

Exclusion Criteria:

• Participants younger than 8 years and older that 25 years and 11 months.

• Previous adverse experience with MPH

• Cardio-vascular diseases including rhythm disorders, severe hypertension, cardiac insufficiency, obliterating cardiac and peripheral arterial disease, preexisting cerebrovascular affections, hemodynamically significant congenital heart defect, channelopathies.

• For the naïve group only: corrected QT (QTc) distance at baseline electrocardiogram above 460 milliseconds or elongation at control electrocardiogram (Day 6 of treatment) superior to 30 milliseconds with functional complaint.

• Psychiatric affections including anxiety attack, psychic tension or restlessness, manic episode, marked psychotic symptoms, schizophrenia, borderline personality disorder, clinical depression (present or past), suicidal episode, diagnosis or family history of Tourette syndrome, alcohol or drug abuse.

• Other somatic affections including hyperthyroid, glaucoma, pheochromocytoma.

• Concurrent treatment with monoamine oxidase inhibitors or interruption less than 14 days before beginning of treatment.

• Pregnancy or breastfeeding.