Phase 2
Completed N=45
Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00636818 ↗Enrolled (actual)
45
Serious AEs
2.3%
Results posted
Dec 2009
Primary outcomePrimary: Discontinuations Due to Adverse Events (AE) — 1; 1 participants
Summary
The primary objective of this clinical study is to assess overall safety and tolerability as measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Discontinuations Due to Adverse Events (AE) |
1; 1 | — |
| SECONDARY Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score |
32.0; -12.8 | <0.001 sig |
| SECONDARY Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S) |
4.8; -1.7 | <0.001 sig |
| SECONDARY Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score |
30.6; -12.1 | <0.001 sig |
| SECONDARY Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) |
4.8; -1.5 | 0.013 sig |
| SECONDARY Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14) |
6.7; -2.0 | 0.005 sig |
| SECONDARY Change From Baseline to 8 Week Endpoint in Stroop Color Word Test |
82.4; 4.5; 68.7; 4.8; 49.0; 3.5 | 0.005 sig |
| SECONDARY Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2) |
46.77; -0.38; 43.71; 3.62; 53.12; -3.02 | 0.791 |
| SECONDARY Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Significant Changes in Body Weight During the Study |
5; 0 | — |
| SECONDARY Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion |
0; 0; 0; 1; 0 | — |
| SECONDARY Cytochrome P450 2D6 (CYP2D6) Phenotype Status |
44; 0 | — |
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 Impressions-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 17-item Hamilton Depression Rating Scale (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 (NCT00636818). 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.