SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Tolerability of SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP).
1 other identifier
interventional
83
1 country
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2012
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2011
CompletedFirst Posted
Study publicly available on registry
November 11, 2011
CompletedStudy Start
First participant enrolled
January 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2013
CompletedResults Posted
Study results publicly available
May 23, 2014
CompletedJune 10, 2021
May 1, 2021
1.5 years
November 9, 2011
April 24, 2014
May 29, 2021
Conditions
Outcome Measures
Primary Outcomes (7)
Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks
Baseline and up to 12 weeks
Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks
Baseline and up to 12 weeks
Change From Baseline in Pulse Rate at Up to 12 Weeks
Baseline and up to 12 weeks
Change From Baseline in Height at up to 12 Weeks
Baseline and up to 12 weeks
Change From Baseline in Weight at up to 12 Weeks
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.
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.
Baseline and up to 12 weeks
Study Arms (2)
SPD503
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
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).
Eligibility Criteria
You may qualify if:
- 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 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 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 Diagnostic and Statistical Manual of Mental Disorders 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 child-bearing potential (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 contraception.
You may not qualify if:
- 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., clinically significant 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 informed consent/assent.
- Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM-IV 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (33)
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
Mt. 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
Related Publications (1)
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.
PMID: 28165762DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Efficacy endpoints were exploratory. No statistical testing was performed because the study was not powered.
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2011
First Posted
November 11, 2011
Study Start
January 4, 2012
Primary Completion
July 15, 2013
Study Completion
July 15, 2013
Last Updated
June 10, 2021
Results First Posted
May 23, 2014
Record last verified: 2021-05