Phase 2
Completed N=45
Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00530335 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcomePrimary: Number of Participants With Adverse Events Leading to Discontinuation — 1; 1; 1 participants
Summary
The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120 mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events Leading to Discontinuation |
1; 1; 1 | — |
| SECONDARY Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J) |
-15.0; -9.9; -5.0; -9.3 | <0.001 sig |
| SECONDARY Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J) |
-11.9; -7.0; -4.9; -6.4 | <0.001 sig |
| SECONDARY Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity |
-1.2 | <0.001 sig |
| SECONDARY Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score |
0.2 | 0.749 |
| SECONDARY Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score |
-0.1 | 0.886 |
| SECONDARY Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores |
47.9; 1.20; 44.46; 0.86; 54.74; -0.63 | — |
| SECONDARY Change From Endpoint to Baseline in Stroop Color Word Test |
91.3; 4.1; 72.8; 4.9; 51.7; 4.2 | 0.005 sig |
| SECONDARY Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study |
4; 0 | — |
| SECONDARY Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion |
1; 0; 0; 4; 0 | — |
| SECONDARY Cytochrome P450 2D6 (CYP2D6) Phenotype Status |
44; 1 | — |
Eligibility Criteria
Inclusion Criteria
- at least 18 years of age
- meet Conners' Adult ADHD Diagnostic Interview for DSM-IV™ (CAADID) diagnostic criteria for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during childhood
- have a Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate symptoms) or greater
Exclusion Criteria
- Patients who meet DSM-IV diagnostic criteria for current major depression and also patients who have total score of more than 12 on the Hamilton Depression Rating Scale-17 items (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or past history of major depression and have received any anti-depression drug therapy within 6 months of Visit 1.
- Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and also require anti-anxiety drug therapy except for those taking benzodiazepines analogues for anxiety which need to be limited.
- Patients who have any history of bipolar disorder (DSM-IV), any history of schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from the study.
- Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.
Data sourced from ClinicalTrials.gov (NCT00530335). 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.