Clinical trial NCT00531752: A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-09-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3
timeFrame: Baseline, Week 3
Secondary outcomes:
measure: Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2
timeFrame: Baseline, Week 1, 2
measure: Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
timeFrame: Week 1, 2, 3
measure: Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S)
timeFrame: Week 1, 2, 3
measure: Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS)
timeFrame: Week 1, 2, 3
measure: Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score
timeFrame: Day 7, 14, 21
measure: Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3
timeFrame: Baseline, Week 1, 2, 3
measure: 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
timeFrame: Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21
measure: Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3
timeFrame: Baseline, Week 3
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3
timeFrame: Baseline, Week 3
measure: Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3
timeFrame: Baseline, Week 3
measure: Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3
timeFrame: Baseline, Week 3
measure: Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3
timeFrame: Baseline, Week 3
Other outcomes:
measure: Change From Baseline in Medical Outcome Study - Sleep Scale (MOS-SS) Subscale Scores at Week 1, 2 and 3
timeFrame: Baseline, Week 1, 2, 3
measure: Change From Baseline in Subjective Sleep Questionnaire (SSQ) Latency Subscale Scores at Week 1, 2 and 3
timeFrame: Baseline, Week 1, 2, 3
measure: Change From Baseline in Subjective Sleep Questionnaire (SSQ) Hours of Sleep Subscale Scores at Week 1, 2 and 3
timeFrame: Baseline, Week 1, 2, 3
measure: Change From Baseline in Subjective Sleep Questionnaire (SSQ) Number of Awakenings Subscale Scores at Week 1, 2 and 3
timeFrame: Baseline, Week 1, 2, 3
measure: Change From Baseline in Subjective Sleep Questionnaire (SSQ) Total Awake After Sleep Onset (WASO) Subscale Scores at Week 1, 2 and 3
timeFrame: Baseline, Week 1, 2, 3
measure: Change From Baseline in Subjective Sleep Questionnaire (SSQ) Quality of Sleep Subscale Scores at Week 1, 2 and 3
timeFrame: Baseline, Week 1, 2, 3
measure: Number of Participants With Clinically Significant Laboratory Test Abnormalities
timeFrame: Baseline up to 1 week after last study dose
measure: Number of Participants With Electrocardiogram (ECG) Findings
timeFrame: Baseline up to End of Treatment (Week 3 of period 2)
measure: Number of Participants With Clinically Significant Vital Sign Abnormalities
timeFrame: Baseline up to 1 week after last study dose
measure: Number of Participants With Change From Baseline in Physical Examination and Neurological Examination
timeFrame: Baseline up to 1 week after last study dose (1 week after end of Period 2)
measure: Treatment Duration
timeFrame: Day 1 up to Day 21
Locations:
city: Lafayette
country: United States
facility: Bay Area Research Institute
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Chicago
country: United States
facility: The University of Illinois at Chicago, Institute for Juvenile Research
state: Illinois
city: Cambridge
country: United States
facility: Massachusetts General Hospital, ADHD Program
state: Massachusetts
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Herndon
country: United States
facility: NeuroScience, Inc
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: