Attention Deficit Hyperactivity Disorder (ADHD)BCADHDNCT03709940
Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD)
A study testing MPH in people with Attention Deficit Hyperactivity Disorder (ADHD), run by King's College London at 1 site in United Kingdom.
Trial summary
This study investigates whether a relationship exists between pre-treatment brain characteristics and treatment response in adults with Attention Deficit Hyperactivity Disorder (ADHD). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- MPH
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 May 2013to 10 Mar 2016
- 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 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- males
- aged 18-45 years old
- intelligent quotient (IQ) > 70 (as measured by WASI)
- diagnosis of ADHD confirmed through clinical assessment (Adult ADHD Clinic)
- non-medicated (stimulant medication-naive or not taking stimulant medication for at least 4 weeks)
Who cannot join
- no other brain disorders other than ADHD
- no condition precluding MRI scanning (e.g., metallic implants, claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD): a Biomarker to Predict Treatment Response
This study investigates whether a relationship exists between pre-treatment brain characteristics and treatment response in adults with Attention Deficit Hyperactivity Disorder (ADHD).
Read the detailed description
There is a pressing need in psychiatry to offer more individualised treatments, and to improve outcomes from clinical trials. This 'individualised medicine' approach requires the development of biomarkers of treatment response.
60 adults with ADHD are recruited from the Adult ADHD Clinic at the Maudsley Hospital, London, United Kingdom.
The study is developed over three sessions, two at baseline (DAY 1 and DAY 2) and one after two months of treatment (follow-up).
The first two sessions are conceived as a single-blind non-randomised placebo-controlled cross-over experiment. The first 30 participants enrolled in the study receive a placebo tablet (ascorbic acid 50 mgs) on DAY 1 before the behavioural assessment and magnetic resonance imaging (MRI) scan. The behavioural assessment and the functional MRI measurements are repeated two days after (DAY 2), under a clinically effective dose (20 mgs) of short-acting methylphenidate (MPH).
The order of the tablets is reverted for the remaining 30 participants to balance any potential expectation and practice effect between the two conditions. Placebo and medication are over-encapsulated with the same red opaque capsules by the pharmacy team. Also, the protocol followed during the two sessions is absolutely identical in respect of timing and tests administered in order to keep the participants blind to the drug condition (medication or placebo).
After the scanning sessions, all the participants receive the same prescription of a long-acting formulation of MPH, according to the clinical guidelines adopted by the Maudsley Hospital. Treatment response is evaluated clinically and behaviourally after 2 months of treatment (follow-up). Pre-treatment brain characteristics are tested as potential predictors (biomarkers) of treatment response.
- Being tested
- MPH
- Keywords
- longitudinal study, magnetic resonance imaging (MRI), brain connectivity, biomarker, treatment response, methylphenidate, stimulant medication
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPHDrug
Also called Methylphenidate
Participants undergo behavioural tests and brain scanning twice, once under placebo and once under an acute dose of MPH, before starting long-term treatment with a long-acting formulation of MPH used routinely at the Adult ADHD Clinic.
| Study group | Role | What they receive |
|---|---|---|
| Placebo, MPH | Experimental | Dose order: placebo, methylphenidate (MPH)
Participants receive a placebo tablet (ascorbic acid 50 mgs) on DAY 1 and a clinically effective dose of short-acting MPH (20 mgs) on DAY 2. Receives: Drug: MPH |
| MPH, Placebo | Experimental | Dose order: methylphenidate (MPH), placebo
Participants receive a clinically effective dose of short-acting MPH (20 mgs) on DAY 1 and a placebo tablet (ascorbic acid 50 mgs) on DAY 2. Receives: Drug: MPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion imaging-based measurements as statistically significant predictors of treatment response (i.e. of participants' performance on adult ADHD rating scale at follow-up as compared to baseline).
Diffusion based measurements include specific measures of anatomical connectivity of pathways originating in the frontal lobes, such as the fronto-striatal pathways and the superior longitudinal fasciculus. According to previously published criteria, treatment response is defined as a symptomatic improvement of at least 30%, as measured by participants' performance on adult ADHD rating scale at follow-up as compared to baseline.
Measured: In the month 2-3 following the last scan.
Secondary outcomes (3)
Functional connectivity measurements as statistically significant predictors of treatment response (i.e. of participants' performance on adult ADHD rating scale at follow-up as compared to baseline).
Functional connectivity measurements include the strength of functional connectivity along pathways originating in the frontal lobes, such as the fronto-striatal pathways and the attentive networks. Treatment response is defined as in outcome 1.
Measured: In the month 4-5 following the last scan.
Diffusion imaging-based measurements as statistically significant predictors of treatment response defined by a data-driven approach.
A categorical approach (data-driven analysis using multivariate k-mean clustering) is used to define treatment response on the basis of clinical and behavioural characteristics at follow-up. Clinical characteristics include participants' performance on adult ADHD rating scale at follow-up as compared to baseline, whereas behavioural characteristics include participants' performance on the Qb test at follow-up as compared to baseline.
Measured: In the month 6-7 following the last scan.
Functional connectivity measurements as statistically significant predictors of treatment response as defined by a data-driven approach.
Treatment response is defined as in outcome 3.
Measured: In the month 8-9 following the last scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start3 May 2013
- Primary completion15 Jan 2015
- Study completion10 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 30 participants with Attention Deficit Hyperactivity Disorder (ADHD) undergo behavioural tests and brain scanning twice, once under placebo and once under an acute dose of methylphenidate (MPH). The order of the tablets is inverted for the second half of the sample, thus the last 30 participants undergo behavioural tests and brain scanning twice, once under an acute dose of MPH and once under placebo. All 60 participants are then treated with a long-acting formulation of MPH used routinely at the Adult ADHD Clinic.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Sponsor
- Investigators
- Declan Murphy, MD, PhD, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709940
- Sponsor's protocol ID
- ConnectADHD
- Acronym
- BCADHD
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parkkinen S, Radua J, Andrews DS, Murphy D, Dell'Acqua F, Parlatini V. Cerebellar network alterations in adult attention-deficit/hyperactivity disorder. J Psychiatry Neurosci. 2024 Jul 3;49(4):E233-E241. doi: 10.1503/jpn.230146. Print 2024 Jul-Aug.
PubMed 38960626
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD): a Biomarker to Predict Treatment Response
- ClinicalTrials.gov ID
- NCT03709940
- Acronym / sponsor ID
- BCADHD / ConnectADHD
- Keywords
- longitudinal study, magnetic resonance imaging (MRI), brain connectivity, biomarker, treatment response, methylphenidate, stimulant medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Shire
- Study start
- 3 May 2013 (actual)
- Primary completion
- 15 Jan 2015 (actual)
- Study completion
- 10 Mar 2016 (actual)
- First posted
- 17 Oct 2018 (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 whether a relationship exists between pre-treatment brain characteristics and treatment response in adults with Attention Deficit Hyperactivity Disorder (ADHD).
Detailed description
There is a pressing need in psychiatry to offer more individualised treatments, and to improve outcomes from clinical trials. This 'individualised medicine' approach requires the development of biomarkers of treatment response.
60 adults with ADHD are recruited from the Adult ADHD Clinic at the Maudsley Hospital, London, United Kingdom.
The study is developed over three sessions, two at baseline (DAY 1 and DAY 2) and one after two months of treatment (follow-up).
The first two sessions are conceived as a single-blind non-randomised placebo-controlled cross-over experiment. The first 30 participants enrolled in the study receive a placebo tablet (ascorbic acid 50 mgs) on DAY 1 before the behavioural assessment and magnetic resonance imaging (MRI) scan. The behavioural assessment and the functional MRI measurements are repeated two days after (DAY 2), under a clinically effective dose (20 mgs) of short-acting methylphenidate (MPH).
The order of the tablets is reverted for the remaining 30 participants to balance any potential expectation and practice effect between the two conditions. Placebo and medication are over-encapsulated with the same red opaque capsules by the pharmacy team. Also, the protocol followed during the two sessions is absolutely identical in respect of timing and tests administered in order to keep the participants blind to the drug condition (medication or placebo).
After the scanning sessions, all the participants receive the same prescription of a long-acting formulation of MPH, according to the clinical guidelines adopted by the Maudsley Hospital. Treatment response is evaluated clinically and behaviourally after 2 months of treatment (follow-up). Pre-treatment brain characteristics are tested as potential predictors (biomarkers) of treatment response.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 30 participants with Attention Deficit Hyperactivity Disorder (ADHD) undergo behavioural tests and brain scanning twice, once under placebo and once under an acute dose of methylphenidate (MPH). The order of the tablets is inverted for the second half of the sample, thus the last 30 participants undergo behavioural tests and brain scanning twice, once under an acute dose of MPH and once under placebo. All 60 participants are then treated with a long-acting formulation of MPH used routinely at the Adult ADHD Clinic.
| Arm | Type | Receives |
|---|---|---|
| Placebo, MPH | Experimental | Drug: MPHDose order: placebo, methylphenidate (MPH) Participants receive a placebo tablet (ascorbic acid 50 mgs) on DAY 1 and a clinically effective dose of short-acting MPH (20 mgs) on DAY 2. |
| MPH, Placebo | Experimental | Drug: MPHDose order: methylphenidate (MPH), placebo Participants receive a clinically effective dose of short-acting MPH (20 mgs) on DAY 1 and a placebo tablet (ascorbic acid 50 mgs) on DAY 2. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- males
- aged 18-45 years old
- intelligent quotient (IQ) > 70 (as measured by WASI)
- diagnosis of ADHD confirmed through clinical assessment (Adult ADHD Clinic)
- non-medicated (stimulant medication-naive or not taking stimulant medication for at least 4 weeks)
Key exclusion criteria (2 listed)
- no other brain disorders other than ADHD
- no condition precluding MRI scanning (e.g., metallic implants, claustrophobia)
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 |
|---|---|---|
| MPHAlso: MethylphenidateParticipants undergo behavioural tests and brain scanning twice, once under placebo and once under an acute dose of MPH, before starting long-term treatment with a long-acting formulation of MPH used routinely at the Adult ADHD Clinic. | Drug | MPH, Placebo, Placebo, MPH |
Primary outcome
Diffusion imaging-based measurements as statistically significant predictors of treatment response (i.e. of participants' performance on adult ADHD rating scale at follow-up as compared to baseline).
Time frame: In the month 2-3 following the last scan.
Diffusion based measurements include specific measures of anatomical connectivity of pathways originating in the frontal lobes, such as the fronto-striatal pathways and the superior longitudinal fasciculus. According to previously published criteria, treatment response is defined as a symptomatic improvement of at least 30%, as measured by participants' performance on adult ADHD rating scale at follow-up as compared to baseline.
3 secondary outcomes
Functional connectivity measurements as statistically significant predictors of treatment response (i.e. of participants' performance on adult ADHD rating scale at follow-up as compared to baseline).
Time frame: In the month 4-5 following the last scan.
Diffusion imaging-based measurements as statistically significant predictors of treatment response defined by a data-driven approach.
Time frame: In the month 6-7 following the last scan.
Functional connectivity measurements as statistically significant predictors of treatment response as defined by a data-driven approach.
Time frame: In the month 8-9 following the last scan.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Derived from this study: PubMed 38960626Parkkinen S, Radua J, Andrews DS, Murphy D, Dell'Acqua F, Parlatini V. Cerebellar network alterations in adult attention-deficit/hyperactivity disorder. J Psychiatry Neurosci. 2024 Jul 3;49(4):E233-E241. doi: 10.1503/jpn.230146. Print 2024 Jul-Aug.
- 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.
Declan Murphy, MD, PhD study director
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 MPH in people with Attention Deficit Hyperactivity Disorder (ADHD), 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 17 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion imaging-based measurements as statistically significant predictors of treatment response (i.e. of participants' performance on adult ADHD rating scale at follow-up as compared to baseline). (time frame: In the month 2-3 following the last scan.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03709940, which also lists 1 linked publication.
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 17 Oct 2018.