CompletedPhase 2

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

United States83 participantsStarted 2012-01-04

Plain-language 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.

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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.

What they're measuring

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

Timeframe: Baseline and up to 12 weeks

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

Timeframe: Baseline and up to 12 weeks

Change From Baseline in Pulse Rate at Up to 12 Weeks

Timeframe: Baseline and up to 12 weeks

Change From Baseline in Height at up to 12 Weeks

Timeframe: Baseline and up to 12 weeks

Change From Baseline in Weight at up to 12 Weeks

Timeframe: Baseline and up to 12 weeks

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

Timeframe: Baseline and up to 12 weeks

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

Timeframe: Baseline and up to 12 weeks

Trial details

NCT IDNCT01470469

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-07-15

Results submitted2014-04-24

View on ClinicalTrials.gov More Generalized Anxiety Disorder (GAD) trials

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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.

What they're measuring

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

Timeframe: Baseline and up to 12 weeks

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

Timeframe: Baseline and up to 12 weeks

Change From Baseline in Pulse Rate at Up to 12 Weeks

Timeframe: Baseline and up to 12 weeks

Change From Baseline in Height at up to 12 Weeks

Timeframe: Baseline and up to 12 weeks

Change From Baseline in Weight at up to 12 Weeks

Timeframe: Baseline and up to 12 weeks

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

Timeframe: Baseline and up to 12 weeks

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

Timeframe: Baseline and up to 12 weeks

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria