Phase 2 N=45 Treatment

Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00636818 ↗

Enrolled (actual)

Serious AEs

2.3%

Results posted

Dec 2009

Primary outcome: Primary: Discontinuations Due to Adverse Events (AE) — 1; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Atomoxetine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Sep 2008

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	—

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).

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.

View full record on ClinicalTrials.gov →

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.