Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder

Last updated: June 23, 2005
Sponsor: National Center for Research Resources (NCRR)
Overall Status: Completed

Phase

3

Condition

Tic Disorders

Williams Syndrome

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

N/A

Clinical Study ID

NCT00004376
199/11979
YALESM-7588
  • Ages 7-16
  • All Genders

Study Summary

OBJECTIVES:

I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit hyperactivity disorder.

Eligibility Criteria

Inclusion

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Tourette syndrome or other chronic tic disorder meeting Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria

  • DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) Clinician's Global Impression for ADHD greater than 4 Hyperactivity Index of Conners Parent or Teacher Questionnaire standard score 65 or higher (1.5 standard deviation units)

--Prior/Concurrent Therapy--

  • At least 2 weeks since medication for tics, ADHD, or obsessive compulsive disorder (4 weeks since neuroleptics or fluoxetine)

  • No failure on prior guanfacine

--Patient Characteristics--

  • Hepatic: No liver failure

  • Renal: No renal failure

  • Cardiovascular: No hypertension No other heart disease

  • Pulmonary: No pulmonary disease

  • Other: No Intelligence Quotient below 80 No current DSM-IV diagnosis of the following: Major depression Bipolar disorder Pervasive developmental disorder Psychotic disorder No seizure disorder No other significant medical condition No pregnant women

Study Design

Total Participants: 35
Study Start date:
September 01, 1994
Estimated Completion Date:
June 30, 2000

Study Description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by pubertal status.

There is a 7- to 14-day washout with a placebo prior to treatment for all patients.

The first group receives oral guanfacine 3 times a day for 8 weeks. The dose is gradually increased to minimize sedation; by day 14, most patients are stabilized and the dose is then increased as clinically indicated and tolerated.

The second group receives a placebo 3 times a day for 8 weeks. Patients in either group may be treated with guanfacine for an additional 8 weeks.