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

NCT ID: NCT01470469

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-04
• Study Completion Date: 2013-07-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SPD503

Group Type: ACTIVE_COMPARATOR

SPD503 (extended-release Guanfacine hydrochloride)

Intervention Type: DRUG

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).

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once-daily oral dosing in the evening for 12 weeks.

Interventions

SPD503 (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).

Intervention Type: DRUG

Placebo

Once-daily oral dosing in the evening for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Intuniv

Eligibility Criteria

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.

11. Subject is unable to limit caffeine intake to 2 servings per day throughout participation in the study beginning at time of informed consent/assent.

12. Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM-IV within the last 6 months.

13. Clinically important abnormality on drug and alcohol screen at the Screening Visit (Visit 1) or Baseline Visit (Visit 2).

14. 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.

15. Subject is well controlled on anxiolytic pharmacologic or non-pharmacologic therapy with acceptable tolerability.

16. 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).

17. Subject is currently using valproic acid or any drug known to inhibit or induce CYP3A4/5 in violation of the protocol-specified washout criteria at the Baseline Visit (Visit 2).

18. Use of another investigational medicinal product or participation in a clinical study within 30 days prior to the Baseline Visit (Visit 2).

19. Subject is significantly overweight based on Center for Disease Control and Prevention body mass index (BMI)-for-age sex specific charts at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >95th percentile for this study.

20. Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to guanfacine hydrochloride or any components found in SPD503.

21. Subject is female and is pregnant or currently lactating.

22. Subject failed screening or was previously enrolled in this study.

23. Subject has another member of the same household currently participating in this study.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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

Institute of Behavioral Medicine, LLC

Smyrna, Georgia, United States

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, United States

Midwest Research Group

Saint Charles, Missouri, United States

Premier Psychiatric Group, LLC

Lincoln, Nebraska, United States

Center for Psychiatry and Behavioral Medicine, Inc

Las Vegas, Nevada, United States

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Columbia University, NY State Psychiatric Institute

New York, New York, United States

Weill Cornell Medical Center

New York, New York, United States

Finger Lakes Clinical Research

Rochester, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Duke University Medical Center, Duke Child and Family Study Center

Durham, North Carolina, United States

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, United States

University Hospitals of Cleveland Medical Center

Cleveland, Ohio, United States

Professional Psychiatric Services

Mason, Ohio, United States

North Star Research

Middleburg Heights, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Research Strategies of Memphis, LLC

Memphis, Tennessee, United States

FutureSearch Clinical Trials, LP

Austin, Texas, United States

Houston Clinical Trials LLC

Houston, Texas, United States

Ericksen Research and Development

Clinton, Utah, United States

NeuroScience, Inc.

Herndon, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28165762 (View on PubMed)

Other Identifiers

SPD503-210

Identifier Type: -

Identifier Source: org_study_id