Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD)

NCT03709940 | Completed

• 1 other identifier: ConnectADHD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates whether a relationship exists between pre-treatment brain characteristics and treatment response in adults with Attention Deficit Hyperactivity Disorder (ADHD).

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

longitudinal study; magnetic resonance imaging (MRI); brain connectivity; biomarker; treatment response; methylphenidate; stimulant medication

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  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.

  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.

  In the month 8-9 following the last scan.

Study Arms (2)

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.

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.

Drug: MPH

Interventions

MPH DRUG

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.

Also known as: Methylphenidate

MPH, Placebo; Placebo, MPH

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• no other brain disorders other than ADHD
• no condition precluding MRI scanning (e.g., metallic implants, claustrophobia)

Sponsors & Collaborators

• King's College London: lead
• Shire: collaborator

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38960626 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

5,10-dihydro-5-methylphenazine; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Declan Murphy, MD, PhD

  King's College London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The first part of the study (DAY 1 and DAY 2) is conceived as a single-blind placebo-controlled cross-over experiment. Participants are blind to the order of the tablets (placebo and MPH). After the two scanning sessions, all 60 participants are started on a long-acting formulation of MPH used routinely at the Adult ADHD Clinic (open trial phase).
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: May 3, 2013
• Primary Completion: January 15, 2015
• Study Completion: March 10, 2016
• Last Updated: October 17, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)