Skip to main content
OpenTrials
Completed

NCT Number: NCT00367835

SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms

To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

HOPE Research Institute, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects with ADHD and oppositional symptoms
  • ADHD-RS>=24
  • CGI >=4
  • T-score of Opp subscale CPRS-R:L >=65
  • Normal ECG and BP
  • >= 55 lbs

Treatment and study plan

SPD503 (Guanfacine hydrochloride)

Drug

Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).

Placebo

Drug

Placebo

Primary outcomes

  1. Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks

    Time frame: Baseline and up to 8 weeks

    The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.

Secondary outcomes

  1. Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks

    Time frame: Baseline and up to 8 weeks

    The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

  2. Assessment of Clinical Global Impression-Severity of Illness (CGI-S)

    Time frame: up to 8 weeks

    CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)

  3. Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)

    Time frame: up to 8 weeks

    CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

  4. Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks

    Time frame: Baseline and up to 8 weeks

    Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity.

  5. Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks

    Time frame: Baseline and up to 8 weeks

    The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents.

  6. Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)

    Time frame: up to 8 weeks

    The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of "strongly agree" or "agree".

  7. Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks

    Time frame: Baseline and up to 8 weeks

    QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.

  8. Change From Baseline in Pulse Rate at Up to 8 Weeks

    Time frame: Baseline and up to 8 weeks

  9. Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks

    Time frame: Baseline and up to 8 weeks

  10. Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks

    Time frame: Baseline and up to 8 weeks

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 23, 2006
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.