CompletedNCT01470469Updated Jun 10, 2021Results posted

SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)

A Phase 2 interventional study of SPD503 (extended-release Guanfacine hydrochloride) and Placebo in Generalized Anxiety Disorder (GAD), Anxiety, Separation and Phobia, Social, sponsored by Shire. Completed at 33 sites in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-06-10.

Sponsored by Shire (part of Takeda) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 83
Allocation: Randomized
Ages: 6 Years to 17 Years
Sex: All

Study summary

This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and ECGs.

Conditions studied

Generalized Anxiety Disorder (GAD)
Anxiety, Separation
Phobia, Social

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In context

Generalized Anxiety Disorder

517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.

This study's enrollment of 83 is close to the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.

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Lead sponsor

Shire is the lead sponsor of 351 studies on the registry; 2 are open to participants now.

Of its 48 completed or terminated interventional studies of FDA-regulated products, 48 (100%) have results posted.

First submitted before Shire became part of Takeda.

Browse Shire studies →All Takeda studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Outpatient subjects aged 6-17 years inclusive at the time of consent/assent (Screening Visit [Visit 1] only).
Subject's parent or legally authorized representative (LAR) must provide signature of , and there must be documentation of assent by the subject indicating that the subject is aware of the nature of the study and the required procedures 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 (Screening Visit [Visit 1] only).
Subject meets Fourth Edition, Text Revision (DSM-IV-TR) criteria for a Primary Diagnosis of 1 or any combination of the following; GAD, SAD or SoP (300.02, 309.21 and 300.23), based on a detailed psychiatric evaluation at screening including completion of the Anxiety Disorders Interview Schedule for DSM-IV Child Version (ADIS-C).
Subject has a score of >/= 4 on the Clinician Severity Rating Scale for the Principal Diagnosis on the ADIS-C CSR) at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2).
Subject is functioning at an age-appropriate level intellectually, as determined by the Investigator.
Subject and parent/LAR understand, are able, willing, and likely to fully comply with the study procedures and restrictions defined in this protocol, in the opinion of the Investigator.
Subject is able to swallow intact tablets.
Subjects who are females of (FOCP), defined as >/= 9 years of age or if \<9 years of age are post-menarchal, must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at the Baseline Visit (Visit 2) and Week 12 (Visit 11/ET). Females of child-bearing potential must abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of .

Exclusion criteria

Exclusion Criteria:

Subject has a current co-morbid psychiatric diagnosis of a major depressive disorder, bipolar illness, psychosis, a pervasive development disorder other than Asperger's Syndrome, attention deficit hyperactivity disorder, an eating disorder, or substance abuse disorder.
Subject has an ADIS-C CSR score for any Axis I disorder that is greater than the ADIS-C CSR score for their Principal Diagnosis of GAD, SAD, or SoP.
Subject has any condition or illness which, in the opinion of the Investigator, represents an inappropriate risk to the subject and/or could confound the interpretation of the study.
Within 14 days prior to the Baseline Visit subject has received any evidence-based psychosocial intervention intended to reduce anxiety symptoms i.e. Individual Cognitive Behavioral Therapy, Group Cognitive Behavioral Therapy, or Social Effectiveness Training.
Subject has started or changed the type or intensity of a non evidence-based psychosocial intervention intended to reduce anxiety symptoms within 6 weeks prior to the Baseline Visit (Visit 2).
Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g., heart block), exercise-related cardiac events including syncope and pre syncope, or clinically significant bradycardia.
Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension.
Subject has a blood pressure measurement above the 95th percentile for age, sex, and height.
Subject has a history of a seizure disorder other than a single childhood febrile seizure occurring before the age of 3 years.
Subject is currently considered at risk for suicide in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
Subject is unable to limit caffeine intake to 2 servings per day throughout participation in the study beginning at time of /assent.
Subject has a history of alcohol or other substance abuse or dependence, as defined by within the last 6 months.
Clinically important abnormality on drug and alcohol screen at the Screening Visit (Visit 1) or Baseline Visit (Visit 2).
History of failure to respond to 2 adequate trials (consisting of an appropriate dose and adequate duration of therapy) of an SSRI or one trial of cognitive behavioral therapy for the treatment of GAD, SAD, or SoP.
Subject is well controlled on anxiolytic pharmacologic or non-pharmacologic therapy with acceptable tolerability.
Subject is currently using a prohibited medication or other medications, including herbal supplements that have identified anxiolytic or anxiogenic effects, that affect BP or heart rate or that have CNS effects in violation of the protocol-specified washout criteria at the Baseline Visit (Visit 2).
Subject is currently using valproic acid or any drug known to inhibit or induce /5 in violation of the protocol-specified washout criteria at the Baseline Visit (Visit 2).
Use of another medicinal product or participation in a clinical study within 30 days prior to the Baseline Visit (Visit 2).
Subject is significantly overweight based on Center for Disease Control and Prevention (BMI)-for-age sex specific charts at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >95th percentile for this study.
Subject has a known or suspected allergy, , or clinically significant intolerance to guanfacine hydrochloride or any components found in SPD503.
Subject is female and is pregnant or currently lactating.
Subject failed screening or was previously enrolled in this study.
Subject has another member of the same household currently participating in this study.

Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 83 participants (actual)

Study arms

Active comparator
SPD503
Drug: SPD503 (extended-release Guanfacine hydrochloride)
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugSPD503 (extended-release Guanfacine hydrochloride)
Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance).
Also known as: Intuniv
DrugPlacebo
Once-daily oral dosing in the evening for 12 weeks.

What researchers measure

Primary outcomes

Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Pulse Rate at Up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Height at up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Weight at up to 12 Weeks
Time frame: Baseline and up to 12 weeks
Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks
QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.
Time frame: Baseline and up to 12 weeks
Change From Baseline in ECG QTcF Interval at up to 12 Weeks
The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.
Time frame: Baseline and up to 12 weeks

Results

Posted May 23, 2014

Limitations and caveats

Efficacy endpoints were exploratory. No statistical testing was performed because the study was not powered.

Participant flow

Participant flow — Overall Study
Milestone	PLACEBO	SPD503
Started	21	62
Completed	11	38
Not completed	10	24
Withdrew: Withdrawal by subject	4	6
Withdrew: Lack of efficacy	1	7
Withdrew: Adverse event	0	7
Withdrew: Lost to follow-up	2	2
Withdrew: Protocol violation	1	1
Withdrew: Other	2	1

Outcome measures

PrimaryChange From Baseline in Systolic Blood Pressure at Up to 12 Weeks

Time frame:: Baseline and up to 12 weeks
Reported as:: Mean · mmHg

Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks
mmHg	PLACEBO	SPD503
Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks	-1.7 ± 11.18	-2.3 ± 11.40

PrimaryChange From Baseline in Diastolic Blood Pressure at Up to 12 Weeks

Time frame:: Baseline and up to 12 weeks
Reported as:: Mean · mmHg

Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks
mmHg	PLACEBO	SPD503
Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks	0.9 ± 7.37	-1.3 ± 9.09

PrimaryChange From Baseline in Pulse Rate at Up to 12 Weeks

Time frame:: Baseline and up to 12 weeks
Reported as:: Mean · beats/min

Change From Baseline in Pulse Rate at Up to 12 Weeks
beats/min	PLACEBO	SPD503
Change From Baseline in Pulse Rate at Up to 12 Weeks	-0.5 ± 11.09	-1.8 ± 11.54

PrimaryChange From Baseline in Height at up to 12 Weeks

Time frame:: Baseline and up to 12 weeks
Reported as:: Mean · cm

Change From Baseline in Height at up to 12 Weeks
cm	PLACEBO	SPD503
Change From Baseline in Height at up to 12 Weeks	0.5 ± 0.91	1.0 ± 1.79

PrimaryChange From Baseline in Weight at up to 12 Weeks

Time frame:: Baseline and up to 12 weeks
Reported as:: Mean · kg

Change From Baseline in Weight at up to 12 Weeks
kg	PLACEBO	SPD503
Change From Baseline in Weight at up to 12 Weeks	0.7 ± 1.73	1.3 ± 1.57

PrimaryChange From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks

QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.

Time frame:: Baseline and up to 12 weeks
Reported as:: Mean · msec

Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks
msec	PLACEBO	SPD503
Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks	0.7 ± 6.50	0.1 ± 5.33

PrimaryChange From Baseline in ECG QTcF Interval at up to 12 Weeks

The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.

Time frame:: Baseline and up to 12 weeks
Reported as:: Mean · msec

Change From Baseline in ECG QTcF Interval at up to 12 Weeks
msec	PLACEBO	SPD503
Change From Baseline in ECG QTcF Interval at up to 12 Weeks	0.3 ± 9.38	4.1 ± 14.01

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
PLACEBO	—	0/21 (0%)	10/21 (47.6%)
SPD503	—	0/62 (0%)	48/62 (77.4%)

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	PLACEBO	SPD503
HeadacheNervous system disorders	4/21	22/62
SomnolenceNervous system disorders	1/21	17/62
FatigueGeneral disorders	0/21	13/62
Abdominal pain upperGastrointestinal disorders	2/21	10/62
Joint sprainInjury, poisoning and procedural complications	3/21	1/62
DizzinessNervous system disorders	1/21	7/62
Dizziness posturalNervous system disorders	0/21	7/62
ConstipationGastrointestinal disorders	0/21	6/62
VomitingGastrointestinal disorders	1/21	6/62
Decreased appetiteMetabolism and nutrition disorders	0/21	6/62

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	PLACEBO	SPD503	Total
Mean	11.8 ± 3.46	11.7 ± 3.39	11.7 ± 3.38

Age, Customized
Age, Customized(Participants)	PLACEBO	SPD503	Total
Age 6-12 years	12	38	50
Age 13-17 years	9	24	33

Sex: Female, Male
Sex: Female, Male(Participants)	PLACEBO	SPD503	Total
Female	10	38	48
Male	11	24	35

Region of Enrollment
Region of Enrollment(Participants)	PLACEBO	SPD503	Total
UNITED STATES	21	62	83

Study locations

33 sites

Birmingham Research Group, Inc
Birmingham, Alabama 35216, United States
Dr. Joseph H. Rodd
Carson, California 90746, United States
Sun Valley Research
Imperial, California 92251, United States
Irvine Center for Clinical Research
Irvine, California 92618, United States
Sharp Mesa Vista Hospital, Clinical Research Department
San Diego, California 92123, United States
Elite Clinical Trials, Inc
Wildomar, California 92595, United States
Florida Clinical Research Center
Bradenton, Florida 34201, United States
Sarkis Clinical Trials
Gainesville, Florida 32607, United States
Kolin Research Group
Winter Park, Florida 32789, United States
Atlanta Center for Medical Research
Atlanta, Georgia 30308, United States
Institute of Behavioral Medicine, LLC
Smyrna, Georgia 30080-6315, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana 70629, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan 48307, United States
Midwest Research Group
Saint Charles, Missouri 63301, United States
Premier Psychiatric Group, LLC
Lincoln, Nebraska 68526, United States
Center for Psychiatry and Behavioral Medicine, Inc
Las Vegas, Nevada 89128, United States
Center for Emotional Fitness
Cherry Hill, New Jersey 08002, United States
Columbia University, NY State Psychiatric Institute
New York, New York 10032, United States
Weill Cornell Medical Center
New York, New York 10065, United States
Finger Lakes Clinical Research
Rochester, New York 14618, United States
Richmond Behavioral Associates
Staten Island, New York 10312, United States
Duke University Medical Center, Duke Child and Family Study Center
Durham, North Carolina 27705-4596, United States
University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
Cincinnati, Ohio 45219, United States
University Hospitals of Cleveland Medical Center
Cleveland, Ohio 44012, United States
Professional Psychiatric Services
Mason, Ohio 45040, United States
North Star Research
Middleburg Heights, Ohio 44130, United States
IPS Research Company
Oklahoma City, Oklahoma 73103, United States
Coastal Carolina Research Center
Mount Pleasant, South Carolina 29464, United States
Research Strategies of Memphis, LLC
Memphis, Tennessee 38119, United States
FutureSearch Clinical Trials, LP
Austin, Texas 78731, United States
Houston Clinical Trials LLC
Houston, Texas 77098, United States
Ericksen Research and Development
Clinton, Utah 84015, United States
NeuroScience, Inc.
Herndon, Virginia 20170, United States

References and documents

Publications

Strawn JR, Compton SN, Robertson B, Albano AM, Hamdani M, Rynn MA. Extended Release Guanfacine in Pediatric Anxiety Disorders: A Pilot, Randomized, Placebo-Controlled Trial. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):29-37. doi: 10.1089/cap.2016.0132. Epub 2017 Feb 6. PubMed 28165762 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01470469
Lead sponsor: Shire
Responsible party: Sponsor
First posted: Nov 11, 2011
Start date: Jan 4, 2012
Primary completion: Jul 15, 2013
Completion: Jul 15, 2013
Results posted: May 23, 2014
Last update: Jun 10, 2021

Study contacts

Study Director

study director · Takeda

View the source record on ClinicalTrials.gov ↗

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