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

COMPLETEDPHASE2

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).

NCT01470469•Shire

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Outpatient subjects aged 6-17 years inclusive at the time of consent/assent (Screening Visit \[Visit 1\] only).
•2. 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).
•3. 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).
•4. 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).
•5. Subject is functioning at an age-appropriate level intellectually, as determined by the Investigator.
•6. 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.
•7. Subject is able to swallow intact tablets.
•8. 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.

Exclusion Criteria

•1. 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.
•2. 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.
•3. 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.
•4. 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.
•5. 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).
•6. 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.
•7. Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension.
•8. Subject has a blood pressure measurement above the 95th percentile for age, sex, and height.
•9. Subject has a history of a seizure disorder other than a single childhood febrile seizure occurring before the age of 3 years.
•10. 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.
+13 more criteria

Locations (33)

Birmingham Research Group, Inc

Birmingham, Alabama, United States

Dr. Joseph H. Rodd

Carson, California, United States

Sun Valley Research

Imperial, California, United States

Irvine Center for Clinical Research

Irvine, California, United States

Sharp Mesa Vista Hospital, Clinical Research Department

San Diego, California, United States

Elite Clinical Trials, Inc

Wildomar, California, United States

Florida Clinical Research Center

Bradenton, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Kolin Research Group

Winter Park, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Key Dates

Start Date

January 4, 2012

Primary Completion Date

July 15, 2013

Completion Date

July 15, 2013

Last Updated

June 10, 2021

Enrollment

ACTUAL participants

Conditions

Generalized Anxiety Disorder (GAD)Anxiety, SeparationPhobia, Social

Interventions

SPD503 (extended-release Guanfacine hydrochloride)

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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