Efficacy of Intuniv Extended Release as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD
Information source: JPM van Stralen Medicine Professional
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Guanfacine extended release (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: JPM van Stralen Medicine Professional Official(s) and/or principal investigator(s): Judy PM van Stralen, MD, Principal Investigator, Affiliation: JPM van Stralen Medicine Professinal Organization
Overall contact: Judy PM van Stralen, MD, Phone: 6137267355, Email: research@drvanstralen.ca
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. 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.
Clinical Details
Official title: A Single-Center, Randomized, Double Blind, Placebo-Controlled, Crossover Evaluation of the Effect of INTUNIV Extended Release as Adjunctive Treatment With Stimulant on Executive Function and Quality of Life at Home and School in Children With ADHD
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To evaluate the effect of adjunctive INTUNIV extended release treatment on executive function as assessed by the BRIEF-parent questionnaires
Secondary outcome: To evaluate the effect of adjunctive INTUNIV extended release treatment on quality of life as assessed by the KINDL®-child and KINDL®-parent questionnaires.To examine the congruency of the perceived effect of treatment on EF and quality of life from the perspective of the subject, parent, and teacher. To evaluate the effect of adjunct therapy on ADHD symptom control as assessed by the ADHD Rating Scale (ADHD-RS-IV) and Clinical Global Impression (CGI) of Severity (CGI-S) and of Improvement (CGI-I) questionnaires. To compare the percentage of subjects experiencing suicidal ideation, suicidal behaviour and self-injurious behaviour without suicidal intent and incident of Serious Adverse Events in each treatment arm
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.
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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
2. Patient's parent or legally authorized representative (LAR) must provide signed
informed consent before any study-related procedures are completed.
3. 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
4. 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.
5. 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.
6. Patient is functioning at an age-appropriate level intellectually, as judged by the
Investigator.
7. Patient is able to swallow intact tablets.
8. 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
9. Patient and parent/LAR understand, are willing, able, and likely to fully comply with
the study procedures and restrictions defined in this protocol.
Exclusion Criteria:
1. 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.
2. 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.
3. 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.
4. 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).
5. Patient has a known history of hypertension (see Blood Pressure Levels for Boys and
Girls by Age and Height Percentile
6. Patient has glaucoma.
7. Patient has a history of a seizure disorder (other than a simple childhood febrile
seizure).
8. Patient has renal or hepatic insufficiency
9. Patient is currently using prohibited medication.
10. Patient has taken another investigational product within 30 days prior to the
Enrolment Visit.
11. 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.
12. History of adverse event or failure to respond (lack of efficacy) to an adequate
trial of an alpha-agonist.
13. Patient is female and is pregnant or currently lactating.
14. 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.
Locations and Contacts
Judy PM van Stralen, MD, Phone: 6137267355, Email: research@drvanstralen.ca
JPM van Stralen Medicine Professional Corporation, Ottawa, Ontario K2G1W2, Canada; Recruiting Judy PM van Stralen, MD, Phone: 6137267355, Email: research@drvanstralen.ca Judy PM van Stralen, MD, Principal Investigator Erica Corsi, MD, Sub-Investigator
Additional Information
Starting date: October 2013
Last updated: November 10, 2013
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