Stimulant and Guanfacine combination for ADHD: (#3) Comorbid Oppositional Symptoms in ADHD.

The following study by Robert L. Findling et al tested the effect of guanfacine extended release (GXR) adjunctive to a psychostimulant on oppositional symptoms in children and adolescents with ADHD.


STUDY DESIGN:

  • Age group: 6-17 yr old
  • n= 207
  • Duration: 9-week double-blind, placebo-controlled dose-optimization study = dose optimization (5 weeks), dose maintenance (3 weeks), and dose tapering (1 week).
  • Inclusion criteria: Subjects were required to have exhibited partial but suboptimal response to treatment with a long-acting oral psychostimulant for ≥4 weeks prior to screening.

Dose of medications:

  • During dose optimization: GXR was initiated at 1 mg/day and titrated in 1-mg/week increments (up to 4 mg/day) to the optimal dose.
  • Subjects continued taking their stable morning psychostimulant dose in addition to morning (a.m.) or evening (p.m.) doses of GXR or placebo. 

RESULTS:

  • Significant reductions from baseline to the final on-treatment assessment on the oppositional subscale of the CPRS–R:L were seen with GXR plus psychostimulant compared with placebo plus psychostimulant.
  • Treatment-emergent adverse events (TEAEs) were reported by 77.3%, 76.3%, and 63.4% of subjects in the GXR a.m., GXR p.m., and placebo groups, respectively.
  • The two most commonly reported TEAEs were headache (21.3% [32/150]) and somnolence (14.0% [21/150]) in the GXR a.m. plus psychostimulant group.
  • The two most commonly reported TEAEs were headache (21.1% [32/152]) and somnolence (13.2% [20/152]) in the GXR p.m.plus psychostimulant group.

CLINICAL TIPS FROM THIS STUDY:

  1. GXR adjunctive to a psychostimulant significantly reduced oppositional symptoms compared with placebo plus a psychostimulant in subjects with ADHD and a suboptimal response to psychostimulant alone.
  2. For subjects with significant oppositional symptoms, the mean (SD) optimal dose of GXR was 3.3 (0.95) mg/day for GXR plus psychostimulant overall.
  3. Significant efficacy as measured by the oppositional subscale of the CPRS–R:L was also demonstrated in the subgroup of subjects presenting with significant oppositional symptoms at baseline. 
  4. Most TEAEs were mild or moderate in severity; and most occurred during the dose-optimization period.

SOURCE: 

  • J Child Adolesc Psychopharmacol. 2014 Jun 1; 24(5): 245–252.

Please do post your questions or comments below. 


Dr. Harvinder Singh, M.D. (Admin)


Enroll in our online course to have access to all important clinically relevant psychiatry topics in one place.


Related Articles