- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00530335
Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)
25 juli 2011 uppdaterad av: Eli Lilly and Company
An Open-Label Pilot Study for Atomoxetine in Adult Subjects With Attention Deficit/Hyperactivity Disorder
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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
45
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Aichi, Japan, 466-8560
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Chiba, Japan, 272-8516
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Fukushima, Japan, 960-1295
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Hokkaido, Japan, 060-8648
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Hyogo, Japan, 661-0002
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Ishikawa, Japan, 920-8641
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kanagawa, Japan, 259-1193
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kumamoto, Japan, 862-0920
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kyoto, Japan, 606-8507
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Nara, Japan, 634-8522
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Saitama, Japan, 350-0495
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Tokyo, Japan, 160-0023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Atomoxetin
|
40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Number of Participants With Adverse Events Leading to Discontinuation
Tidsram: over 8 weeks
|
over 8 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)
Tidsram: baseline and 8 weeks
|
Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently).
Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.
|
baseline and 8 weeks
|
Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)
Tidsram: baseline and 8 weeks
|
Scale=30 items divided between 3 subscales: inattention (9 items), hyperactivity-impulsivity (9 items), and ADHD index (12 items), using a 4-point scale (0=not at all/never to 3=very much/very frequently).
Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) with range of scores from 0 to 54.
|
baseline and 8 weeks
|
Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity
Tidsram: baseline and 8 weeks
|
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
|
baseline and 8 weeks
|
Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score
Tidsram: baseline and 8 weeks
|
The 17-item HAMD measures depression severity.
Each item was evaluated and scored using either a 5-point scale (e.g.
absent, mild, moderate, severe, very severe) or a 3-point scale (e.g.
absent, mild, marked).
The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
|
baseline and 8 weeks
|
Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score
Tidsram: baseline and 8 weeks
|
The 14-item HAMA assesses the severity of anxiety.
The investigator talked to the patient about their symptoms over the previous week before the study visit.
Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe.
The total score of HAMA-14 may range from 0 (normal) to 56 (severe).
|
baseline and 8 weeks
|
Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores
Tidsram: baseline and 8 weeks
|
Derivation of norm-based scoring: Items re-scored to ensure choices were in consistent order and sum up converted score in each subscale; Transform subscale score; Normalize transformed subscale score (i.e. Z-score) using Japanese mean and standard deviation of SF-36v2 subscales. Calculate: norm-based score=Z-score*10+50 in each subscale. |
baseline and 8 weeks
|
Change From Endpoint to Baseline in Stroop Color Word Test
Tidsram: baseline and 8 weeks
|
An assessment of response inhibition.
Three timed tests: reading color words in black ink; reading the printed colored ink; and reading color words printed in different colored ink.
There were 100 items for each of the three test categories and if they made it through the 100 words with time remaining, they would repeat the list.
|
baseline and 8 weeks
|
Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
Tidsram: over 8 weeks
|
Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).
|
over 8 weeks
|
Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study
Tidsram: over 8 weeks
|
Potentially clinically significant weight loss was defined as any decrease of at least 7%.
Potentially clinically significant weight gain was defined as any increase of at least 7%.
|
over 8 weeks
|
Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
Tidsram: over 8 weeks
|
The Fridericia correction of the QT interval(QTcF) was used.
|
over 8 weeks
|
Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Tidsram: 8 weeks
|
CYP2D6 is the primary atomoxetine metabolizing enzyme.
Metabolizer status was determined by focusing on the normal, decreased, and defective allele.
Poor metabolizer = defective/defective.
Extensive metabolizer is all except for poor metabolizer.
|
8 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2007
Primärt slutförande (Faktisk)
1 april 2008
Avslutad studie (Faktisk)
1 april 2008
Studieregistreringsdatum
Först inskickad
14 september 2007
Först inskickad som uppfyllde QC-kriterierna
14 september 2007
Första postat (Uppskatta)
17 september 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 juli 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juli 2011
Senast verifierad
1 juli 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Sjukdomar i nervsystemet
- Neurologiska manifestationer
- Dyskinesier
- Uppmärksamhetsbrist och störande beteendestörningar
- Neuropsykiatriska funktionsnedsättningar
- Attention Deficit Disorder med hyperaktivitet
- Hyperkinesis
- Läkemedels fysiologiska effekter
- Adrenerga medel
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Neurotransmittorupptagshämmare
- Membrantransportmodulatorer
- Adrenerga upptagshämmare
- Atomoxetinhydroklorid
Andra studie-ID-nummer
- 11821
- B4Z-JE-LYED (Annan identifierare: Eli Lilly and Company)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Attention Deficit Hyperactivity Disorder
-
Purdue Pharma LPAvslutadAttention Deficit/Hyperactivity DisorderFörenta staterna
-
The Hospital for Sick ChildrenEhave; Ontario Brain InstituteAvslutadAttention-deficit Hyperactivity DisorderKanada
-
National Taiwan University HospitalAvslutadAttention-deficit/Hyperactivity Disorder
-
National Taiwan University HospitalNational Science Council, TaiwanOkändAttention Deficit/Hyperactivity DisorderTaiwan
-
National Taiwan University HospitalAvslutadAttention-deficit/Hyperactivity DisorderTaiwan
-
Ornit CohenOkändAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder med hyperaktivitet | Attention Deficit Disorder | Attention Deficit Disorders med hyperaktivitet | Attention Deficit Hyperactivity DisordersIsrael
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)RekryteringAttention-Deficit Hyperactivity DisorderFörenta staterna
-
Ironshore Pharmaceuticals and Development, IncAvslutadAttention-Deficit Hyperactivity DisorderFörenta staterna
-
Florida International UniversityAvslutadAttention-deficit/Hyperactivity DisorderFörenta staterna
-
National Taiwan University HospitalOkändAttention Deficit/Hyperactivity DisorderTaiwan
Kliniska prövningar på Atomoxetine
-
Boehringer IngelheimRekryteringAttention Deficit Hyperactivity DisorderTyskland
-
Eli Lilly and CompanyAvslutadAttention Deficit Hyperactivity Disorder | TrotssyndromItalien
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA)AvslutadMetamfetaminberoende | MetamfetaminmissbrukFörenta staterna
-
Brigham and Women's HospitalHar inte rekryterat ännu
-
ApnimedAvslutadObstruktiv sömnapnéFörenta staterna
-
Children's Hospital Los AngelesBaylor College of Medicine; Children's Hospital of Philadelphia; Children... och andra samarbetspartnersAvslutadDjup ventrombosFörenta staterna
-
University of California, San FranciscoAvslutadFeokromocytom | ParagangliomFörenta staterna
-
Seoul National University HospitalKyung Hee University Hospital at GangdongAvslutadNeurogen ortostatisk hypotensionKorea, Republiken av
-
Lindner Center of HOPEUniversity of CincinnatiAvslutad
-
Yale UniversityAvslutadKokainberoende | OpiatberoendeFörenta staterna