Clinical Trial: Adult Attention Deficit Hyperactivity Disorder

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

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

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

Detailed Summary: This is a Phase 2, randomized, double-blind, parallel-group, multicenter, outpatient study evaluating the efficacy and safety of SEP 225289 in adults with ADHD using 2 oral dosages (4 or 8 mg SEP 225289 once daily [QD]) versus placebo over a 4 week treatment period.
Sponsor: Sunovion

Current Primary Outcome: Change From Baseline at Week 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV) [ Time Frame: 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.


Original Primary Outcome: Change From Baseline at Week 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV) [ Time Frame: 4 Weeks ]

Current Secondary Outcome:

  • Change From Baseline in ADHD Symptoms Measured With the ADHD RS IV at Weeks 1, 2, 3. [ Time Frame: Weeks 1, 2, 3 ]
    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 (range 0 - 54).
  • Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI S) at Weeks 1, 2, 3, 4. [ Time Frame: Weeks 1, 2, 3, 4 ]
    The CGI-S modified asked the clinician one question: Considering your total clinical experience with adult ADHD, how mentally ill is the subject at this time?".The clinician's answer was rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = ng the most extremely ill subjects.
  • Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4 [ Time Frame: Weeks 1, 2, 3, 4 ]
    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 even number items (2, 4, 6, 8, 10, 12, 14, 16, 18) assess hyperactive impulsive symptoms and the odd number items (1, 3, 5, 7, 9, 11, 13, 15, 17) assess inattentive symptoms. The ADHD inattentiveness subscale score is defined as sum of items (1, 3, 5, 7, 9, 11, 13, 15, 17) scores (range 0 - 27). The ADHD hyperactive impulsive subscale score is defined as sum of items (2, 4, 6, 8, 10, 12, 14, 16, 18) scores (range 0 - 27).
  • The Number of Responders at Weeks 1, 2, 3, 4. A Responder is Defined as a Subject With a ≥ 30% Improvement in ADHD Symptoms Compared With Baseline as Measured by the ADHD RS IV. [ Time Frame: Weeks 1, 2, 3, 4 ]
  • Change From Baseline in the Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADDS) as Measured at Weeks 1, 2, 3, 4. [ Time Frame: Weeks 1, 2, 3, 4 ]
    The WRAADDS measured the severity of the target symptoms of adults with ADHD. It measured symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rated individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) and summarized each of the 7 categories on a 0 to 4 scale (0 = none, 1 = mild, 2 = moderate, 3 = quite a bit, 4 = very much). The WRAADDS total score is defined as sum of all 28 item subscores (range 0 - 56).


Original Secondary Outcome:

  • Change from baseline in ADHD symptoms measured with the ADHD RS IV at Weeks 1, 2, 3, and 6. [ Time Frame: Weeks 1, 2, 3, 4, and 6 ]
  • Change from baseline in Clinical Global Impression - Severity of Illness scale (CGI S) at Weeks 1, 2, 3, 4, and 6. [ Time Frame: Weeks 1, 2, 3, 4, and 6 ]
  • Change from baseline in the inattentiveness and hyperactivity subscales of the ADHD RS IV at Weeks 1, 2, 3, 4, and 6 [ Time Frame: Weeks 1, 2, 3, 4, and 6 ]
  • The percentage of responders at Weeks 1, 2, 3, 4, and 6. A responder is defined as a subject with a ≥ 30% improvement in ADHD symptoms compared with baseline as measured by the ADHD RS IV. [ Time Frame: Weeks 1, 2, 3, 4, and 6 ]
  • Change from baseline in cognition as measured by the CDR Computerized Cognitive Assessment System at Weeks 2, 4, and 6. [ Time Frame: Weeks 2, 4, and 6 ]
  • Change from baseline in the WRAADDS as measured at Weeks 1, 2, 3, 4, and 6. [ Time Frame: Weeks 1, 2, 3, 4, and 6 ]


Information By: Sunovion

Dates:
Date Received: September 18, 2012
Date Started: December 2012
Date Completion:
Last Updated: January 9, 2015
Last Verified: January 2015