SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)
Condition: Generalized Anxiety Disorder (GAD); Anxiety, Separation; Phobia, Social
MeSH terms: Anxiety Disorders; Phobic Disorders; Phobia, Social; Anxiety, Separation
Intervention: SPD503 (extended-release Guanfacine hydrochloride); Placebo
Intervention description: 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).; Once-daily oral dosing in the evening for 12 weeks.
Intervention MeSH terms: Guanfacine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

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 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.