Attention Deficit Hyperactivity DisorderPhase 4NCT01985581
Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD
A Phase 4 study testing Guanfacine extended release and Stimulant therapy in people with Attention Deficit Hyperactivity Disorder, run by JPM van Stralen Medicine Professional at 1 site in Canada.
Trial summary
This study looks to examine whether or not INTUNIV extended release can help children aged 6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving Executive Function when added to their usual care stimulant therapy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Guanfacine extended release and Stimulant therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Mar 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patient aged 6 to 12 years at the time of consent/assent and to then of study. A patient who would turn 13 before the end of the study cannot be enrolled
- Patient's parent or legally authorized representative (LAR) must provide signed informed consent before any study-related procedures are completed.
- Patient meets the diagnostic standard manual-5 criteria for a primary diagnosis of ADHD, combined sub-type, hyperactive/impulsive sub-type, or inattentive sub-type
- Patient is currently on a stable stimulant regimen but whose EF is suboptimal. Suboptimal EF is defined as a global executive composite t-score greater than 65 (>1.5 SD from mean) on the BRIEF-P questionnaire at screening.
- Patient who is currently and is expected to remain on a stable stimulant regimen throughout the study. A stable stimulant regimen is defined as:
- •No significant change in dose or dosing frequency within the past 30 days prior to screening and stimulant is felt to be optimized by the investigator.
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- Patient is functioning at an age-appropriate level intellectually, as judged by the Investigator.
- Patient is able to swallow intact tablets.
- Patient has sitting blood pressure (BP) measurement within the 95th percentile for age, sex, and height (see Blood Pressure Levels for Boys and Girls by Age and Height Percentile
- Patient and parent/LAR understand, are willing, able, and likely to fully comply with the study procedures and restrictions defined in this protocol.
Who cannot join
- Patient has a current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis [except oppositional defiant disorder (ODD)], including any severe co-morbid Axis II disorders or severe Axis I disorders such as post-traumatic stress disorder (PTSD), bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder (OCD), substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis or conduct disorder.
- Patient has any condition or illness which, in the opinion of the Investigator, represents an inappropriate risk to the patient and/or could confound the interpretation of the study. Mild stable asthma treated without the use of beta-2 agonist is not exclusionary.
- Patient has a known personal history, or presence, of structural cardiac abnormalities, cardiovascular or cerebrovascular disease, serious heart rhythm abnormalities, syncope, tachycardia, cardiac conduction problems (e.g., clinically significant heart block or QT interval prolongation: QTc >0.44 seconds), exercise-related cardiac events including syncope and pre-syncope, or clinically significant bradycardia.
- Patient has a known family history (in siblings, parents, and/or grand-parents) of sudden cardiac death, ventricular arrhythmia, or QT prolongation (QTc >0.44 seconds).
- Patient has a known history of hypertension (see Blood Pressure Levels for Boys and Girls by Age and Height Percentile
- Patient has glaucoma.
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- Patient has a history of a seizure disorder (other than a simple childhood febrile seizure).
- Patient has renal or hepatic insufficiency
- Patient is currently using prohibited medication.
- Patient has taken another investigational product within 30 days prior to the Enrolment Visit.
- Patient has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or any of its active ingredients or patient is taking other products containing guanfacine.
- History of adverse event or failure to respond (lack of efficacy) to an adequate trial of an alpha-agonist.
- Patient is female and is pregnant or currently lactating.
- Patient is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicide ideation. Patients with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
Trial locations and contacts
1 site in 1 country.
Canada1 site
JPM van Stralen Medicine Professional Corporation
Ottawa, Ontario, K2G1W2
About this study
Official title: A Single-Center, Randomized, Double Blind, Placebo-Controlled, Crossover Evaluation of the Effect of GXR as Adjunctive Treatment With Stimulant on Executive Function and Quality of Life at Home and School in Children With ADHD
This study looks to examine whether or not INTUNIV extended release can help children aged 6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving Executive Function when added to their usual care stimulant therapy. Executive functions are a set of mental processes that include emotional control, planning, organization, working memory, inhibition of behaviors, and managing time and space. As children with ADHD usually have difficulties with Executive Function, and Executive function difficulties lead to more difficulties in school and behaviour, it is anticipated that adding INTUNIV extended release to usual stimulant therapy will improve Executive Function scores as rated by parents and teachers. Improvements in quality of life will also be measured.
Read the detailed description
Although stimulant medications have been shown to have positive impact on executive function (EF) (Findling et al, 2009; Hale et al. 2011), little has been documented about the effect of INTUNIV extended release on EF in children. The manifestation of clinical symptoms related to impairment in EF often leads to the search for additional treatment options and in many cases to adjunct therapies to the traditional stimulant medication treatment regimen. Demonstrating that the addition of INTUNIV extended release to usual stimulant therapy is effective for symptom control as well as in improving EF may influence clinical treatment algorithms and the need for health care resources to effectively manage patients. Since EF deficits negatively impact academic achievement and behavior at school and because children spend a large number of daytime hours at school, the concordance of any reported improvement in the school and the home environment will be examined. Overall improvement in quality of life with the addition of INTUNIV extended release will also be evaluated.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Guanfacine extended release, Placebo, Stimulant therapy
- Keywords
- Attention Deficit Hyperactivity Disorder, Intuniv extended release, Executive Function, Quality of Life
- 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.
Guanfacine extended releaseDrug
Also called Intuniv extended release
PlaceboDrug
Stimulant therapyDrug
patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
| Study group | Role | What they receive |
|---|---|---|
| Placebo first then GXR | Experimental | patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine). In the first intervention period subject took placebo and second intervention period subject took GXR. GXR dose was optimized to between 1 and 4mg. Receives: Drug: Guanfacine extended release; Drug: Placebo; Drug: Stimulant therapy |
| GXR first then Placebo | Placebo comparator | patient will continue to take stable dosage of usual stimulant(Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine). In the first intervention period subject took GXR and second intervention period subject took placebo. GXR dose was optimized to between 1 and 4mg. Receives: Drug: Guanfacine extended release; Drug: Placebo; Drug: Stimulant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires
The Behavioural Rating Inventory of Executive Function (BRIEF) was developed to assess such real-world expressions of executive function in the home (BRIEF-P) as assessed by the parent. This is an 86 item questionnaire completed by the parents. The score is converted to a t-score with a score less than 65 being considered within the normal range. Higher scores are worsening in function.
Measured: measured at baseline and end of each 12 week treament arm
Secondary outcomes (6)
Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire.
The KINDL is a quality of life questionnaire of 24 items completed by the subject (KINDL-child). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the child
Measured: Measured at baseline and end of each 12 week treatment arm
Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV)
The ADHD-RS-IV is completed by the Investigator familiar with the scale. It is an 18 item scale designed to reflect current symptomatology of ADHD based on the DSM-5 criteria. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, with higher scores reflecting more severe symptoms
Measured: comparison from baseline to end of each 12 week treatment arm
Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm
To compare the number of subjects experiencing suicidal ideation, suicidal behaviour and self-injurious behaviour without suicidal intent as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and incident of Serious Adverse Events (SAEs) in each treatment arm
Measured: Measured up to 30 weeks
Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire.
The KINDL is a quality of life questionnaire of 24 items completed by the parent (KINDL-parent). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the parent.
Measured: Measured at baseline and end of each 12 week treatment arm
Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change on the Clinical Global Impression of Severity (CGI-S) Scale
The Clinical Global Impression- Severity scale is a scale of illness ranging from 1 (normal) to 7 (among the most severely ill patients). Subjects who felt normal, not at all ill or borderline mentally ill are considered improved. The outcome measure is reporting the percentage of participants showing improvement
Measured: comparison from baseline to end of each 12 week treatment arm
Evaluate the Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in Clinical Global Impression of Improvement (CGI-I) Scale
CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Subjects who felt very much improved or much improved are considered improved.The outcome measure is reporting the percentage of participants showing improvement
Measured: comparison from baseline to end of each 12 week treatment arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- JPM van Stralen Medicine Professional
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judy PM van Stralen, MD, Principal investigator, JPM van Stralen Medicine Professinal Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985581
- Sponsor's protocol ID
- RES 13-001
- Status last verified
- May 2016
- First submitted
- 27 Oct 2013
- Last updated
- 23 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double Blind, Placebo-Controlled, Crossover Evaluation of the Effect of GXR as Adjunctive Treatment With Stimulant on Executive Function and Quality of Life at Home and School in Children With ADHD
- ClinicalTrials.gov ID
- NCT01985581
- Acronym / sponsor ID
- RES 13-001
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Intuniv extended release, Executive Function, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- JPM van Stralen Medicine ProfessionalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Posted 23 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks to examine whether or not INTUNIV extended release can help children aged 6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving Executive Function when added to their usual care stimulant therapy. Executive functions are a set of mental processes that include emotional control, planning, organization, working memory, inhibition of behaviors, and managing time and space. As children with ADHD usually have difficulties with Executive Function, and Executive function difficulties lead to more difficulties in school and behaviour, it is anticipated that adding INTUNIV extended release to usual stimulant therapy will improve Executive Function scores as rated by parents and teachers. Improvements in quality of life will also be measured.
Detailed description
Although stimulant medications have been shown to have positive impact on executive function (EF) (Findling et al, 2009; Hale et al. 2011), little has been documented about the effect of INTUNIV extended release on EF in children. The manifestation of clinical symptoms related to impairment in EF often leads to the search for additional treatment options and in many cases to adjunct therapies to the traditional stimulant medication treatment regimen. Demonstrating that the addition of INTUNIV extended release to usual stimulant therapy is effective for symptom control as well as in improving EF may influence clinical treatment algorithms and the need for health care resources to effectively manage patients. Since EF deficits negatively impact academic achievement and behavior at school and because children spend a large number of daytime hours at school, the concordance of any reported improvement in the school and the home environment will be examined. Overall improvement in quality of life with the addition of INTUNIV extended release will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo first then GXR | Experimental | Drug: Guanfacine extended release, Drug: Placebo, Drug: Stimulant therapypatient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine). In the first intervention period subject took placebo and second intervention period subject took GXR. GXR dose was optimized to between 1 and 4mg. |
| GXR first then Placebo | Placebo comparator | Drug: Guanfacine extended release, Drug: Placebo, Drug: Stimulant therapypatient will continue to take stable dosage of usual stimulant(Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine). In the first intervention period subject took GXR and second intervention period subject took placebo. GXR dose was optimized to between 1 and 4mg. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Male or female patient aged 6 to 12 years at the time of consent/assent and to then of study. A patient who would turn 13 before the end of the study cannot be enrolled
- Patient's parent or legally authorized representative (LAR) must provide signed informed consent before any study-related procedures are completed.
- Patient meets the diagnostic standard manual-5 criteria for a primary diagnosis of ADHD, combined sub-type, hyperactive/impulsive sub-type, or inattentive sub-type
- Patient is currently on a stable stimulant regimen but whose EF is suboptimal. Suboptimal EF is defined as a global executive composite t-score greater than 65 (>1.5 SD from mean) on the BRIEF-P questionnaire at screening.
- Patient who is currently and is expected to remain on a stable stimulant regimen throughout the study. A stable stimulant regimen is defined as:
Key exclusion criteria (14 listed)
- Patient has a current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis [except oppositional defiant disorder (ODD)], including any severe co-morbid Axis II disorders or severe Axis I disorders such as post-traumatic stress disorder (PTSD), bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder (OCD), substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis or conduct disorder.
- Patient has any condition or illness which, in the opinion of the Investigator, represents an inappropriate risk to the patient and/or could confound the interpretation of the study. Mild stable asthma treated without the use of beta-2 agonist is not exclusionary.
- Patient has a known personal history, or presence, of structural cardiac abnormalities, cardiovascular or cerebrovascular disease, serious heart rhythm abnormalities, syncope, tachycardia, cardiac conduction problems (e.g., clinically significant heart block or QT interval prolongation: QTc >0.44 seconds), exercise-related cardiac events including syncope and pre-syncope, or clinically significant bradycardia.
- Patient has a known family history (in siblings, parents, and/or grand-parents) of sudden cardiac death, ventricular arrhythmia, or QT prolongation (QTc >0.44 seconds).
- Patient has a known history of hypertension (see Blood Pressure Levels for Boys and Girls by Age and Height Percentile
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 |
|---|---|---|
| Guanfacine extended releaseAlso: Intuniv extended release | Drug | GXR first then Placebo, Placebo first then GXR |
| Placebo | Drug | GXR first then Placebo, Placebo first then GXR |
| Stimulant therapypatient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) | Drug | GXR first then Placebo, Placebo first then GXR |
Primary outcome
Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires
Time frame: measured at baseline and end of each 12 week treament arm
The Behavioural Rating Inventory of Executive Function (BRIEF) was developed to assess such real-world expressions of executive function in the home (BRIEF-P) as assessed by the parent. This is an 86 item questionnaire completed by the parents. The score is converted to a t-score with a score less than 65 being considered within the normal range. Higher scores are worsening in function.
6 secondary outcomes
Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire.
Time frame: Measured at baseline and end of each 12 week treatment arm
Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV)
Time frame: comparison from baseline to end of each 12 week treatment arm
Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm
Time frame: Measured up to 30 weeks
Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire.
Time frame: Measured at baseline and end of each 12 week treatment arm
Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change on the Clinical Global Impression of Severity (CGI-S) Scale
Time frame: comparison from baseline to end of each 12 week treatment arm
Evaluate the Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in Clinical Global Impression of Improvement (CGI-I) Scale
Time frame: comparison from baseline to end of each 12 week treatment arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Judy PM van Stralen, MD principal investigator
JPM van Stralen Medicine Professinal Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guanfacine extended release and Stimulant therapy in people with Attention Deficit Hyperactivity Disorder, run by JPM van Stralen Medicine Professional at 1 site in Canada.
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 14 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 23 May 2016. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires (time frame: measured at baseline and end of each 12 week treament arm). 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 23 May 2016.