Brain Response to Serotonergic Medications in ASD

NCT04145076 | Unknown

• 1 other identifier: 14/LO/0663
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism Spectrum Disorder

Keywords

citalopram; tianeptine; pharmacological imaging

Outcome Measures

Primary Outcomes (3)

• Brain excitation and inhibition response to pharmacological stimulation as assessed by magnetic resonance spectroscopy

  The measure of brain excitation and inhibition response to placebo, citalopram, and tianeptine includes the following: Assessment of the ratio of brain excitation and inhibition (measured as the balance of excitatory and inhibitory neurotransmitters) using proton magnetic resonance spectroscopy.

  In the months 1-2 following the last day of scanning

• Brain activation response to pharmacological stimulation as assessed by functional magnetic resonance imaging

  The measure of brain activation response to placebo, citalopram, and tianeptine includes the following: Assessment of the blood-oxygen-level-dependent activation during tasks using functional magnetic resonance imaging.

  In the months 3-4 following the last day of scanning

• Brain connectivity response to pharmacological stimulation as assessed by resting-state functional magnetic resonance imaging

  The measure of brain connectivity response to placebo, citalopram, and tianeptine includes the following: Assessment of the regional homogeneity during resting-state using functional magnetic resonance imaging.

  In the months 5-6 following the last day of scanning

Study Arms (6)

Placebo, Citalopram, Tianeptine

EXPERIMENTAL

Dose order: Placebo, Citalopram, Tianeptine

Drug: Placebo; Drug: Citalopram; Drug: Tianeptine

Placebo, Tianeptine, Citalopram

EXPERIMENTAL

Dose order: Placebo, Tianeptine, Citalopram

Drug: Placebo; Drug: Citalopram; Drug: Tianeptine

Citalopram, Placebo, Tianeptine

EXPERIMENTAL

Dose order: Citalopram, Placebo, Tianeptine

Drug: Placebo; Drug: Citalopram; Drug: Tianeptine

Citalopram, Tianeptine, Placebo

EXPERIMENTAL

Dose order: Citalopram, Tianeptine, Placebo

Drug: Placebo; Drug: Citalopram; Drug: Tianeptine

Tianeptine, Placebo, Citalopram

EXPERIMENTAL

Dose order: Tianeptine, Placebo, Citalopram

Drug: Placebo; Drug: Citalopram; Drug: Tianeptine

Tianeptine, Citalopram, Placebo

EXPERIMENTAL

Dose order: Tianeptine, Citalopram, Placebo

Drug: Placebo; Drug: Citalopram; Drug: Tianeptine

Interventions

Placebo DRUG

Two oral doses of placebo.

Citalopram, Placebo, Tianeptine; Citalopram, Tianeptine, Placebo; Placebo, Citalopram, Tianeptine; Placebo, Tianeptine, Citalopram; Tianeptine, Citalopram, Placebo; Tianeptine, Placebo, Citalopram

Citalopram DRUG

Single oral dose of citalopram (20mg) and single oral dose of placebo.

Citalopram, Placebo, Tianeptine; Citalopram, Tianeptine, Placebo; Placebo, Citalopram, Tianeptine; Placebo, Tianeptine, Citalopram; Tianeptine, Citalopram, Placebo; Tianeptine, Placebo, Citalopram

Tianeptine DRUG

Single oral dose of tianeptine (12.5mg) and single oral dose of placebo.

Citalopram, Placebo, Tianeptine; Citalopram, Tianeptine, Placebo; Placebo, Citalopram, Tianeptine; Placebo, Tianeptine, Citalopram; Tianeptine, Citalopram, Placebo; Tianeptine, Placebo, Citalopram

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Intelligence Quotient (IQ) above 70
• Has capacity and is capable of giving written informed consent
• Able to read, comprehend and record information written in English
• Bodyweight of \<120 kg and BMI within the range 18.5 - 33 kg/m2 (inclusive).
• Not taking medication directly affecting gamma-aminobutyric acid (GABA) neurotransmission for at least the past 4 weeks
• Not taking medication directly affecting the serotonergic system for at least the past 4 weeks
• ASD only: Diagnosis of Autism Spectrum Disorder (ICD 10-R criteria, confirmed using the Autism Diagnostic Interview (ADI) and/or ADOS) including atypical autism
• ASD only: Being recommended drug therapy for symptoms of depression and/or anxiety
• Controls only: No diagnosis of Autism Spectrum Disorder (ICD 10-R criteria, confirmed using the ADI and/or ADOS)
• Controls only: No diagnosis of major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or ICD 10.

You may not qualify if:

• Current risk of self-harm
• Acute risk of suicidality (e.g., current suicidal ideations)
• Age \< 18 years or \> 60 years old.
• Taking medication directly affecting the serotonergic system (e.g. SSRIs, Tricyclic antidepressants)
• Taking medication directly affecting GABA neurotransmission (e.g. antiepileptic drugs, and benzodiazepines)
• Taking antipsychotic medication or medication for attention deficit hyperactivity disorder (ADHD) for the past 4 weeks
• History of dependence to alcohol or substances of abuse (excluding nicotine)
• Major mental illness (e.g. psychosis), or a learning disability (mental retardation)
• Needle phobia
• Medical/genetic disorder associated with ASD
• Diagnosed and treated for hyperkinesis or Tourette's syndrome
• Allergy to food colouring

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Citalopram; tianeptine

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Grainne McAlonan, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

• Declan Murphy, PhD

  King's College London

  STUDY CHAIR

Central Study Contacts

Nichol Wong, PhD

CONTACT

+44 (0)2078480124; nichol.wong@kcl.ac.uk

Grainne McAlonan, PhD

CONTACT

+44 (0)2078480831; grainne.mcalonan@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators are blinded to the drug condition.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy head of department

Model Details: Repeated-measures cross-over study, where each subject receives each of three pharmacological probes once (order of drug administration was pseudorandomised).

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 30, 2019
• Study Start: December 15, 2014
• Primary Completion: February 1, 2023
• Study Completion: May 31, 2023
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)