A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD).
Source: ClinicalTrials.gov NCT00531752 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 3 |
36.778; 38.273; 36.135; -7.196; -5.745; -6.789 | 0.6749 |
| SECONDARY Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score at Week 1 and 2 |
-4.942; -3.591; -5.524; -6.022; -5.7; -7.109 | 0.5643 |
| SECONDARY Percentage of Participants With at Least 30 Percent Decrease From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score |
15.385; 13.636; 24; 26.087; 30; 30.435 | — |
| SECONDARY Percentage of Participants With 1 or 2 Score on Clinical Global Impression-Severity Scale (CGI-S) |
3.846; 4.545; 2; 0.0; 5; 4.082 | — |
| SECONDARY Percentage of Participants With Less Than or Equal to 18 Score on Adult ADHD Investigator Symptom Rating Scale (AISRS) |
11.538; 4.545; 14; 21.739; 10; 13.043 | — |
| SECONDARY Percentage of Participants With Sustained Response of at Least 30 Percent Decrease From Baseline in Time-Sensitive ADHD Symptom Scale (TASS) Total Score |
38.095; 27.778; 33.333; 23.529; 31.25; 31.429 | — |
| SECONDARY Change From Baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) Subscale Scores at Week 1, 2 and 3 |
-3.423; -1.636; -3.36; -4.326; -2.65; -4.022 | 0.8708 |
| SECONDARY 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 |
-0.46; 2.205; -4.75; -1.78; -0.952; -6.031 | 0.0392 sig |
| SECONDARY Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 3 |
6.63; 7.773; 6.962; -2.19; -1.289; -0.524 | 0.0913 |
| SECONDARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score at Week 3 |
5.333; 6.045; 5.327; -0.944; -0.19; -0.487 | 0.5466 |
| SECONDARY Change From Baseline in ADHD Impact Module - Adults (AIM-A) Subscale Score at Week 3 |
6.481; 6.409; 6.423; 1.815; 1.705; 1.663 | 0.7415 |
| SECONDARY Change From Baseline in Adult ADHD Quality of Life Scale (AAQOL) Subscale Score at Week 3 |
306.481; 292.045; 281.25; 163.889; 146.591; 167.788 | 0.5241 |
| SECONDARY Change From Baseline in Sheehan Disability Scale (SDS) Subscale Scores at Week 3 |
6.058; 6.095; 6.36; 4.593; 5.227; 5.01 | 0.3320 |
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.
Data sourced from ClinicalTrials.gov (NCT00531752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.