Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial
— BCADHDOfficial title:
Brain Connectivity in Attention Deficit Hyperactivity Disorder (ADHD): a Biomarker to Predict Treatment Response
NCT number | NCT03709940 |
Other study ID # | ConnectADHD |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 3, 2013 |
Est. completion date | March 10, 2016 |
Verified date | October 2018 |
Source | King's College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigates whether a relationship exists between pre-treatment brain characteristics and treatment response in adults with Attention Deficit Hyperactivity Disorder (ADHD).
Status | Completed |
Enrollment | 60 |
Est. completion date | March 10, 2016 |
Est. primary completion date | January 15, 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - no other brain disorders other than ADHD - no condition precluding MRI scanning (e.g., metallic implants, claustrophobia) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College London | London |
Lead Sponsor | Collaborator |
---|---|
King's College London | Shire |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | In the month 4-5 following the last scan. | |
Secondary | 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. | In the month 6-7 following the last scan. | |
Secondary | 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. | In the month 8-9 following the last scan. |
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