Brain Response to Serotonergic Medications in ASD

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: King's College London
• Treatments: Citalopram; Dexetimide; Tianeptine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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