A Phase Iia, Randomized, Double Blind, Placebo Controlled, Three-treatment, Two-period Crossover Study Of The Efficacy And Safety Of Two Doses Of Pf-03654746 In Adults With Attention Deficit Hyperactivity Disorder
Overview
- Phase
- Phase 2
- Intervention
- PF-03654746
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Pfizer
- Enrollment
- 66
- Locations
- 6
- Primary Endpoint
- Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine whether PF-03654746 is effective in the treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized, double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg), and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants will be required to washout of prior ADHD medication before entering the study. Participants will be required to come to the site for 10 visits over approximately a 10-week period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview.
- •Male and female outpatients. Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview.
- •Female subjects must be of non-childbearing potential.
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension), hepatic, neurologic, or allergic disease.
- •Current or lifetime history of psychosis or bipolar disorder; any current anxiety disorder (with the exception of social or specific phobia), or substance abuse or dependence in the past 6 months.
- •Current episode of Major Depression or episode within the last 6 months.
Arms & Interventions
Flexible Dose
Intervention: PF-03654746
Placebo
Intervention: Placebo capsules
Fixed Dose
Intervention: PF-03654746
Outcomes
Primary Outcomes
Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3
Time Frame: Baseline, Week 3
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
Secondary Outcomes
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3(Baseline, Week 3)
- Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2(Baseline, Week 1, 2)
- Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S)(Week 1, 2, 3)
- Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)(Week 1, 2, 3)
- Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3(Baseline, Week 1, 2, 3)
- Change From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score on Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 21(Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21)
- Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3(Baseline, Week 3)
- Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3(Baseline, Week 3)
- Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score(Week 1, 2, 3)
- Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score(Day 7, 14, 21)
- Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3(Baseline, Week 3)
- Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3(Baseline, Week 3)