- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00530335
Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)
25. Juli 2011 aktualisiert von: 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
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
45
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Interventionsmodell: Fakultätszuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Atomoxetin
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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
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Number of Participants With Adverse Events Leading to Discontinuation
Zeitfenster: over 8 weeks
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over 8 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Investigator Rated: Screening Version - Japanese Version (CAARS-Inv:SV-J)
Zeitfenster: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Change From Endpoint to Baseline in Connors's Adult ADHD Rating Scale-Self Report: Screening Version - Japanese Version (CAARS-S:SV-J)
Zeitfenster: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Change From Endpoint to Baseline in Clinical Global Impression-ADHD - Severity
Zeitfenster: baseline and 8 weeks
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Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
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baseline and 8 weeks
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Change From Endpoint to Baseline in Hamilton Depression Rating Scale - 17 Items (HAMD-17) Total Score
Zeitfenster: baseline and 8 weeks
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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).
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baseline and 8 weeks
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Change From Endpoint to Baseline in Hamilton Anxiety Rating Scale - 14 Items (HAMA) Total Score
Zeitfenster: baseline and 8 weeks
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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).
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baseline and 8 weeks
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Change From Endpoint to Baseline in 36-item Short-Form Health Survey (SF-36v2) Norm-based Subdomain and Summary Scores
Zeitfenster: baseline and 8 weeks
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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
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Change From Endpoint to Baseline in Stroop Color Word Test
Zeitfenster: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study
Zeitfenster: over 8 weeks
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Vital signs reported are Pulse (beats per minute [bpm]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).
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over 8 weeks
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Number of Participants With Potentially Clinically Significant Changes in Body Weight During the Study
Zeitfenster: over 8 weeks
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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%.
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over 8 weeks
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Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion
Zeitfenster: over 8 weeks
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The Fridericia correction of the QT interval(QTcF) was used.
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over 8 weeks
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Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Zeitfenster: 8 weeks
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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.
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8 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. September 2007
Primärer Abschluss (Tatsächlich)
1. April 2008
Studienabschluss (Tatsächlich)
1. April 2008
Studienanmeldedaten
Zuerst eingereicht
14. September 2007
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. September 2007
Zuerst gepostet (Schätzen)
17. September 2007
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
27. Juli 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
25. Juli 2011
Zuletzt verifiziert
1. Juli 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Erkrankungen des Nervensystems
- Neurologische Manifestationen
- Dyskinesien
- Aufmerksamkeitsdefizit und störende Verhaltensstörungen
- Neuroentwicklungsstörungen
- Aufmerksamkeitsdefizitstörung mit Hyperaktivität
- Hyperkinese
- Physiologische Wirkungen von Arzneimitteln
- Adrenerge Wirkstoffe
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Hemmer der Aufnahme von Neurotransmittern
- Membrantransportmodulatoren
- Adrenerge Aufnahmehemmer
- Atomoxetinhydrochlorid
Andere Studien-ID-Nummern
- 11821
- B4Z-JE-LYED (Andere Kennung: Eli Lilly and Company)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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