A Randomized, Double Blind, Parallel Group, Multicenter Efficacy and Safety Study of SEP-225289 Versus Placebo in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT01692782 Phase 2 COMPLETED Results posted

A Phase 2 study of SEP-225289 in adults with attention deficit hyperactivity disorder (ADHD).

Details

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	341
Start date	2012-12
Completion	2013-12

Conditions

• Adult Attention Deficit Hyperactivity Disorder

Interventions

• SEP-225289
• SEP-225289
• Placebo

Primary outcomes

• Change From Baseline at Week 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV) — 4 Weeks
  The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores.

Countries

United States