NCT04145076

Brain Response to Serotonergic Medications in ASD

Can Brain Activation and Connectivity Predict Treatment Response to Two Serotonergic Medications (Citalopram and Tianeptine) in Subjects With Autism Spectrum Disorders (ASD)?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study investigates brain response to single acute dose of citalopram, tianeptine, and placebo in males with and without autism spectrum disorder.

Detailed description

There is increasing evidence that the serotonin (5-HT) system is implicated in autism spectrum disorder (ASD), with the standard treatment for depression and anxiety in both the general population and ASD includes targeting the 5-HT system with selective serotonin reuptake inhibitors (SSRIs) citalopram. Some individuals with ASD have a good treatment response but others do not. Tianeptine, which has a different mechanism of action to SSRIs, is also an effective antidepressant. As it is unlikely that all individuals with ASD will respond to the same treatment, the investigators aim to conduct a pharmacological magnetic resonance imaging (phMRI) investigation to elucidate the neural mechanisms underlying the response to citalopram and tianeptine in ASD. The investigators are inviting 50 male adults with ASD and 50 male adults without ASD. Each participant receives each drug once (20 mg citalopram, 12.5 mg tianeptine, or placebo) and MRI is used to obtain measures of brain biochemistry, activity, and connectivity. The investigators also acquire data from questionnaires, electroencephalography, neurocognitive tests and blood samples.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Two oral doses of placebo.
DRUG	Citalopram	Single oral dose of citalopram (20mg) and single oral dose of placebo.
DRUG	Tianeptine	Single oral dose of tianeptine (12.5mg) and single oral dose of placebo.

Timeline

• Start date: 2014-12-15
• Primary completion: 2023-02-01
• Completion: 2023-05-31
• First posted: 2019-10-30
• Last updated: 2022-04-15

Locations

1 site across 1 country: United Kingdom