Clinical Trial: Safety and Efficacy of GTS21 in Adults With Attention-deficit Hyperactivity Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Randomized, Proof-of-Concept Crossover Trial to Assess the Effects of GTS21 on Cognitive Function, Clinical Symptoms, and Adverse Events in Adults Diagnosed With Attention-Deficit

Brief Summary: This study will be a randomized, double-blind, placebo-controlled crossover study to assess the effects of GTS21 (25 mg three times a day (tid), 75 mg tid, 150 mg tid) compared to placebo in non-smoking adults aged 18-55 with a diagnosis of ADHD, any subtype.

Detailed Summary:
Sponsor: CoMentis

Current Primary Outcome: To Assess the Safety and Tolerability of GTS21 (25 mg Tid, 75 mg Tid, 150 mg Tid). [ Time Frame: Baseline to study completion ]

The proportion of subjects with Treatment Emergent Adverse Events.


Original Primary Outcome: To assess the safety and tolerability of GTS21 (25 mg tid, 75 mg tid, 150 mg tid) based on treatment emergent adverse events (AE's), clinical laboratory tests, physical examinations, vital signs, and electrocardiograms (ECG's)

Current Secondary Outcome:

Original Secondary Outcome:

  • To assess the efficacy of GTS21 (25 mg tid, 75 mg tid, 150 mg tid) as measured by the mean difference between treatment with drug and treatment with placebo on a clinician administered version of the Conners' Adult ADHD Rating Scale (CAARS)
  • To assess the acute and sub-chronic effects of GTS21 on computerized assessments of attention, inhibitory control, and working memory in adults with ADHD
  • To determine the self-perceived change in cognitive and affective state with treatment and placebo


Information By: CoMentis

Dates:
Date Received: January 4, 2007
Date Started: February 2007
Date Completion:
Last Updated: August 16, 2010
Last Verified: August 2010