Autism Spectrum DisorderNCT04145076
Brain Response to Serotonergic Medications in ASD
A study testing Citalopram and Tianeptine in people with Autism Spectrum Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
This study investigates brain response to single acute dose of citalopram, tianeptine, and placebo in males with and without autism spectrum disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Citalopram and Tianeptine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2014to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, SE5 8AF
Nichol Wong, PhD, +44 (0)2078480124, nichol.wong@kcl.ac.uk
About this study
Official title: Can Brain Activation and Connectivity Predict Treatment Response to Two Serotonergic Medications (Citalopram and Tianeptine) in Subjects With Autism Spectrum Disorders (ASD)?
This study investigates brain response to single acute dose of citalopram, tianeptine, and placebo in males with and without autism spectrum disorder.
Read the 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
- Being tested
- Placebo, Citalopram, Tianeptine
- Keywords
- citalopram, tianeptine, pharmacological imaging
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Two oral doses of placebo.
CitalopramDrug
Single oral dose of citalopram (20mg) and single oral dose of placebo.
TianeptineDrug
Single oral dose of tianeptine (12.5mg) and single oral dose of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Placebo, Citalopram, Tianeptine | Experimental | Dose order: Placebo, Citalopram, Tianeptine Receives: Drug: Placebo; Drug: Citalopram; Drug: Tianeptine |
| Placebo, Tianeptine, Citalopram | Experimental | Dose order: Placebo, Tianeptine, Citalopram Receives: Drug: Placebo; Drug: Citalopram; Drug: Tianeptine |
| Citalopram, Placebo, Tianeptine | Experimental | Dose order: Citalopram, Placebo, Tianeptine Receives: Drug: Placebo; Drug: Citalopram; Drug: Tianeptine |
| Citalopram, Tianeptine, Placebo | Experimental | Dose order: Citalopram, Tianeptine, Placebo Receives: Drug: Placebo; Drug: Citalopram; Drug: Tianeptine |
| Tianeptine, Placebo, Citalopram | Experimental | Dose order: Tianeptine, Placebo, Citalopram Receives: Drug: Placebo; Drug: Citalopram; Drug: Tianeptine |
| Tianeptine, Citalopram, Placebo | Experimental | Dose order: Tianeptine, Citalopram, Placebo Receives: Drug: Placebo; Drug: Citalopram; Drug: Tianeptine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: In the months 5-6 following the last day of scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start15 Dec 2014
- Primary completionFeb 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated-measures cross-over study, where each subject receives each of three pharmacological probes once (order of drug administration was pseudorandomised).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Grainne McAlonan, King's College London
- Investigators
- Grainne McAlonan, PhD, Principal investigator, King's College LondonDeclan Murphy, PhD, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145076
- Sponsor's protocol ID
- 14/LO/0663
- Status last verified
- Apr 2022
- First submitted
- 25 Oct 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Brain Activation and Connectivity Predict Treatment Response to Two Serotonergic Medications (Citalopram and Tianeptine) in Subjects With Autism Spectrum Disorders (ASD)?
- ClinicalTrials.gov ID
- NCT04145076
- Acronym / sponsor ID
- 14/LO/0663
- Conditions
- Autism Spectrum Disorder
- Keywords
- citalopram, tianeptine, pharmacological imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Repeated-measures cross-over study, where each subject receives each of three pharmacological probes once (order of drug administration was pseudorandomised).
| Arm | Type | Receives |
|---|---|---|
| Placebo, Citalopram, Tianeptine | Experimental | Drug: Placebo, Drug: Citalopram, Drug: TianeptineDose order: Placebo, Citalopram, Tianeptine |
| Placebo, Tianeptine, Citalopram | Experimental | Drug: Placebo, Drug: Citalopram, Drug: TianeptineDose order: Placebo, Tianeptine, Citalopram |
| Citalopram, Placebo, Tianeptine | Experimental | Drug: Placebo, Drug: Citalopram, Drug: TianeptineDose order: Citalopram, Placebo, Tianeptine |
| Citalopram, Tianeptine, Placebo | Experimental | Drug: Placebo, Drug: Citalopram, Drug: TianeptineDose order: Citalopram, Tianeptine, Placebo |
| Tianeptine, Placebo, Citalopram | Experimental | Drug: Placebo, Drug: Citalopram, Drug: TianeptineDose order: Tianeptine, Placebo, Citalopram |
| Tianeptine, Citalopram, Placebo | Experimental | Drug: Placebo, Drug: Citalopram, Drug: TianeptineDose order: Tianeptine, Citalopram, Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTwo oral doses of placebo. | Drug | Citalopram, Placebo, Tianeptine, Citalopram, Tianeptine, Placebo, Placebo, Citalopram, Tianeptine, Placebo, Tianeptine, Citalopram, Tianeptine, Citalopram, Placebo, Tianeptine, Placebo, Citalopram |
| CitalopramSingle oral dose of citalopram (20mg) and single oral dose of placebo. | Drug | Citalopram, Placebo, Tianeptine, Citalopram, Tianeptine, Placebo, Placebo, Citalopram, Tianeptine, Placebo, Tianeptine, Citalopram, Tianeptine, Citalopram, Placebo, Tianeptine, Placebo, Citalopram |
| TianeptineSingle oral dose of tianeptine (12.5mg) and single oral dose of placebo. | Drug | Citalopram, Placebo, Tianeptine, Citalopram, Tianeptine, Placebo, Placebo, Citalopram, Tianeptine, Placebo, Tianeptine, Citalopram, Tianeptine, Citalopram, Placebo, Tianeptine, Placebo, Citalopram |
Primary outcome
Brain excitation and inhibition response to pharmacological stimulation as assessed by magnetic resonance spectroscopy
Time frame: In the months 1-2 following the last day of scanning
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.
Brain activation response to pharmacological stimulation as assessed by functional magnetic resonance imaging
Time frame: In the months 3-4 following the last day of scanning
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.
Brain connectivity response to pharmacological stimulation as assessed by resting-state functional magnetic resonance imaging
Time frame: In the months 5-6 following the last day of scanning
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grainne McAlonan, PhD principal investigator
King's College London
Declan Murphy, PhD study chair
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citalopram and Tianeptine in people with Autism Spectrum Disorder, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nichol Wong, PhD (+44 (0)2078480124, nichol.wong@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain excitation and inhibition response to pharmacological stimulation as assessed by magnetic resonance spectroscopy (time frame: In the months 1-2 following the last day of scanning). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.