Attention-Deficit/Hyperactivity DisorderPhase 3NCT01081132
Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl
A Phase 3 study testing Extended-release Guanfacine Hydrochloride in people with Attention-Deficit/Hyperactivity Disorder, run by Shire at 54 sites in United States.
Trial summary
To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured by the ADHD-RS-IV Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Extended-release Guanfacine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 54 sitesUnited States
- Study dates
- 19 Sep 2011to 16 May 2013
- Phase
- Phase 3
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female, aged 13-17 years at the time of consent/assent (screening only).
- Subject's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidance E6 (1996) and applicable regulations before completing any study-related procedures at screening.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD, combined subtype, or hyperactive/impulsive subtype, based on a detailed psychiatric evaluation using the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K SADS PL) at screening (re-confirm if baseline visit is >35 days from screening).
- Subject has a minimum ADHD-RS-IV total score of 32 at baseline.
- Subject has a minimum CGI-S score of 4 at baseline.
- Subject is functioning at an age-appropriate level intellectually, as deemed by the Investigator.
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- Subject and parent/LAR understand, are able, willing and likely to fully comply with the study procedures and restrictions defined in this protocol.
- Subject is able to swallow intact tablets.
- All females must have a negative serum beta human Chorionic Gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test at baseline. Female subjects must abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception.
- Subject has a supine and standing blood pressure (BP) measurement within the 95th percentile for age, gender, and height.
Who cannot join
- Subject has a current, controlled (requiring a prohibited medication or behavioral modification program) or uncontrolled, comorbid psychiatric diagnosis [except Oppositional Defiant Disorder (ODD), but including all anxiety disorders (except simple phobias)], all major depressive disorders (dysthymia allowed unless medication required), and any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse disorder, or other symptomatic manifestations that, in the opinion of the Investigator, contraindicate SPD503 treatment or confound efficacy or safety assessments.
- Subject has any condition or illness including clinically significant abnormal screening laboratory values which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study.
- Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g., clinically significant heart block), exercise-related cardiac events including syncope and pre-syncope, or clinically significant bradycardia.
- Subject has any abnormal or clinically significant ECG findings as judged by the Investigator with consideration of the central ECG interpretation.
- Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension.
- Current use of any prohibited medication, including herbal supplements that affect blood pressure, heart rate, have central nervous system (CNS) effects, or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (i.e., antihistamines) at baseline.
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- Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM IV-TR (with the exceptions of nicotine) within the last six months.
- Subject has taken another investigational product within 30 days prior to baseline.
- Subject is significantly overweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at screening. Significantly overweight is defined as a BMI >95th percentile for this study.
- Body weight of less than 34.0kg or greater than 91.0kg at screening.
- Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or any components found in SPD503.
- Clinically important abnormality on urine drug and/or alcohol screen (excluding the subject's current ADHD stimulant if applicable).
- Subject is female and is pregnant or currently lactating.
- Subject failed screening or was previously enrolled in this study.
- Subject who is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.
- History of failure to respond to an adequate trial (consisting of an appropriate dose and adequate duration of therapy), in the opinion of the Investigator, of an α2-agonist for the treatment of ADHD.
- Subject has a history of a seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years) or a history of a tic disorder (including Tourette's syndrome).
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109
FutureSearch Trials
Austin, Texas, 78731
Rainbow Research
Barnwell, South Carolina, 29812
NorthCoast Clinical Trials
Beachwood, Ohio, 44122
Northwest Clinical Research Center
Bellevue, Washington, 98007
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201
IMMUNO International Research Centers
Centennial, Colorado, 80112
The Ohio State University
Columbus, Ohio, 43210
InSite Clinical Research
DeSoto, Texas, 75115
Harmonex Neuroscience Research
Dothan, Alabama, 36303
Triangle Neuropsychiatry
Durham, North Carolina, 27707
Sarkis Clinical Trials
Gainesville, Florida, 32607
Comprehensive Psychiatric Associates
Gladstone, Missouri, 64118
Neuroscience, Inc.
Herndon, Virginia, 20170
Amedica Research Institute, Inc.
Hialeah, Florida, 33013
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260
The Jackson Clinic
Jackson, Tennessee, 38305
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
George M. Joseph, MD, PA
Jacksonville Beach, Florida, 32250
East Side Therapeutic Resource
Kirkland, Washington, 98033
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Capstone Clinical Research
Libertyville, Illinois, 60048
Clinical Study Centers, LLC
Little Rock, Arkansas, 72211
Westex Clinical Investigations
Lubbock, Texas, 79423
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38119
AMR-Baber Research Inc.
Naperville, Illinois, 60563
Coastal Connecticut Research LLC
New London, Connecticut, 06320
IPS Research Company
Oklahoma City, Oklahoma, 73103
Morteza Nadjafi, MD, FAPA
Orlando, Florida, 32803
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Psychiatric Associates
Overland Park, Kansas, 66211
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003
CRI Worldwide
Philadelphia, Pennsylvania, 19139
OCCI, Inc.
Portland, Oregon, 97210
Alliance Research Group
Richmond, Virginia, 23230
Finger Lakes Clinical Research
Rochester, New York, 14618
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Northwest Behavioral Research Center
Roswell, Georgia, 30076
St Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63301
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
San Diego, California, 92108
Institute for Behavioral Medicine
Smyrna, Georgia, 30080
Miami Research Associates
South Miami, Florida, 33143
Encompass Clinical Research
Spring Valley, California, 91978
Richmond Behavioral Associates
Staten Island, New York, 10312
Clinical Neurophysiology Services, PC
Sterling Heights, Michigan, 48314
Clinco, Inc.
Terre Haute, Indiana, 47802
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104
University Services Sleep Diagnostic and Treatment Centers
West Chester, Pennsylvania, 19380
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
Elite Clinical Trials, Inc.
Wildomar, California, 92595
About this study
Official title: A Phase 3, Double-blind, Randomized, Multi-center, Placebo Controlled, Dose-optimization Study Evaluating the Safety, Efficacy, and Tolerability of Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Adolescents Aged 13-17 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)
To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured by the ADHD-RS-IV
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Extended-release Guanfacine Hydrochloride, Placebo
- 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.
Extended-release Guanfacine HydrochlorideDrug
Also called Intuniv
The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on weight.
PlaceboOther
Matching placebo will be provided as 1,2,3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on weight.
| Study group | Role | What they receive |
|---|---|---|
| Extended-release Guanfacine HCl | Experimental | Not described Receives: Drug: Extended-release Guanfacine Hydrochloride |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Measured: Baseline through week 13
Secondary outcomes (16)
Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment
CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill)
Measured: Baseline through week 13
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Learning and School Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Measured: Baseline and week 13
Change From Baseline in the WFIRS-P Family Domain Score at Week 13
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Family Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Measured: Baseline and week 13
Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Measured: Baseline and week 13
Change From Baseline in the WFIRS-P Global Domain Score at Week 13
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Measured: Baseline and week 13
Change From Baseline in the WFIRS-P Risk Domain Score at Week 13
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Risk Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Measured: Baseline and week 13
Change From Baseline in the WFIRS-P Social Domain Score at Week 13
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Social Domain consists of 7-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Measured: Baseline and week 13
Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 13
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Child Self-Concept Domain consists of 3-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Measured: Baseline and week 13
Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 13
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Life Skills Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Measured: Baseline and week 13
Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 13
The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Measured: Baseline and week 13
Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores at the Last On-Treatment Assessment
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Measured: weeks 1 through 13
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at Week 13
Behavior Rating Inventory of Executive Function (BRIEF) is a questionnaire composed of three indices: Global Executive Composite, Behavioral Regulation Index, and Metacognition Index. Items are rated 1 (never), 2 (sometimes), and 3 (often). The Global Executive Composite consists of 72 items with scoring ranging from 72 to 216. The Behavioral Regulation Index score is the total of 28 items and ranges from 28 to 84. The Metacognition Index score is the total of 44 items and ranges from 44 to 132. Lower scores reflect better functioning.
Measured: Baseline and week 13
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 13
The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 item questionnaire scored on a scale from 0 (never) to 4 (always/very often). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness.
Measured: Baseline through week 13
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Last On-Treatment Assessment
The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
Measured: Baseline and week 13
Structure Side-Effect Questionnaire (SSEQ)
The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking 'yes' or 'no' on the checklist for each of the events listed.
Measured: Through week 16
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Measured: Through week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study start19 Sep 2011
- Primary completion16 May 2013
- Study completion16 May 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081132
- Sponsor's protocol ID
- SPD503-312
- Other IDs
- 2011-002221-21
- Status last verified
- Jun 2021
- First submitted
- 3 Mar 2010
- Last updated
- 28 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wilens TE, Robertson B, Sikirica V, Harper L, Young JL, Bloomfield R, Lyne A, Rynkowski G, Cutler AJ. A Randomized, Placebo-Controlled Trial of Guanfacine Extended Release in Adolescents With Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2015 Nov;54(11):916-25.e2. doi: 10.1016/j.jaac.2015.08.016. Epub 2015 Sep 15.
PubMed 26506582
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blind, Randomized, Multi-center, Placebo Controlled, Dose-optimization Study Evaluating the Safety, Efficacy, and Tolerability of Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Adolescents Aged 13-17 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01081132
- Acronym / sponsor ID
- SPD503-312
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2011 (actual)
- Primary completion
- 16 May 2013 (actual)
- Study completion
- 16 May 2013 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Posted 23 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured by the ADHD-RS-IV
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended-release Guanfacine HCl | Experimental | Drug: Extended-release Guanfacine Hydrochloride |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Male or female, aged 13-17 years at the time of consent/assent (screening only).
- Subject's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidance E6 (1996) and applicable regulations before completing any study-related procedures at screening.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD, combined subtype, or hyperactive/impulsive subtype, based on a detailed psychiatric evaluation using the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K SADS PL) at screening (re-confirm if baseline visit is >35 days from screening).
- Subject has a minimum ADHD-RS-IV total score of 32 at baseline.
- Subject has a minimum CGI-S score of 4 at baseline.
Key exclusion criteria (17 listed)
- Subject has a current, controlled (requiring a prohibited medication or behavioral modification program) or uncontrolled, comorbid psychiatric diagnosis [except Oppositional Defiant Disorder (ODD), but including all anxiety disorders (except simple phobias)], all major depressive disorders (dysthymia allowed unless medication required), and any severe comorbid Axis II disorders or severe Axis I disorders such as post traumatic stress disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse disorder, or other symptomatic manifestations that, in the opinion of the Investigator, contraindicate SPD503 treatment or confound efficacy or safety assessments.
- Subject has any condition or illness including clinically significant abnormal screening laboratory values which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study.
- Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g., clinically significant heart block), exercise-related cardiac events including syncope and pre-syncope, or clinically significant bradycardia.
- Subject has any abnormal or clinically significant ECG findings as judged by the Investigator with consideration of the central ECG interpretation.
- Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension.
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 |
|---|---|---|
| Extended-release Guanfacine HydrochlorideAlso: IntunivThe test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on weight. | Drug | Extended-release Guanfacine HCl |
| PlaceboMatching placebo will be provided as 1,2,3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on weight. | Other | Placebo |
Primary outcome
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13
Time frame: Baseline through week 13
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
16 secondary outcomes
Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment
Time frame: Baseline through week 13
Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13
Time frame: Baseline and week 13
Change From Baseline in the WFIRS-P Family Domain Score at Week 13
Time frame: Baseline and week 13
Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13
Time frame: Baseline and week 13
Change From Baseline in the WFIRS-P Global Domain Score at Week 13
Time frame: Baseline and week 13
Change From Baseline in the WFIRS-P Risk Domain Score at Week 13
Time frame: Baseline and week 13
Change From Baseline in the WFIRS-P Social Domain Score at Week 13
Time frame: Baseline and week 13
Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 13
Time frame: Baseline and week 13
Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 13
Time frame: Baseline and week 13
Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 13
Time frame: Baseline and week 13
Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores at the Last On-Treatment Assessment
Time frame: weeks 1 through 13
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at Week 13
Time frame: Baseline and week 13
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 13
Time frame: Baseline through week 13
Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Last On-Treatment Assessment
Time frame: Baseline and week 13
Structure Side-Effect Questionnaire (SSEQ)
Time frame: Through week 16
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Through week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26506582Wilens TE, Robertson B, Sikirica V, Harper L, Young JL, Bloomfield R, Lyne A, Rynkowski G, Cutler AJ. A Randomized, Placebo-Controlled Trial of Guanfacine Extended Release in Adolescents With Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2015 Nov;54(11):916-25.e2. doi: 10.1016/j.jaac.2015.08.016. Epub 2015 Sep 15.
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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.
Study Director study director
Takeda
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extended-release Guanfacine Hydrochloride in people with Attention-Deficit/Hyperactivity Disorder, run by Shire at 54 sites in United States.
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 17 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 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2014). 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?
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13 (time frame: Baseline through week 13). 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 NCT01081132, 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 28 Jun 2021; AzTrials last refreshed its copy on 3 Nov 2026.