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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00969618 |
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Date of registration:
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31/08/2009 |
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Primary sponsor: |
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Public title:
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A Long Term Follow-Up Study for Asian Adult Patients With Attention Deficit Hyperactivity Disorder
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Scientific title:
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Long-Term, Open-Label Safety and Efficacy Study of Atomoxetine Hydrochloride in Adult Patients With Attention-Deficit/Hyperactivity Disorder (ADHD) |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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178 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00969618 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who have completed the B4Z-JE-LYEE study and signed the ICD.
- Patients must have been judged by the investigator to be reliable to keep
appointments for clinic visits and all tests, including venipuncture and
examinations, required by the protocol.
- Patients must possess an educational level and degree of understanding of the
language of their country that enables them to communicate suitably with the
investigator and study coordinator.
Exclusion Criteria:
- Patients who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition, Text Revision criteria for current anxiety disorder and also patients who
require anti-anxiety drug therapy within previous study except for those taking
benzodiazepines analogs for anxiety. The dosage of diazepam equivalents should not
be more than 5 mg/day.
- Patients who, in the opinion of the investigator, are at serious suicidal risk or
serious risk of harming others, or whose score for Item 11 on the Hamilton Depression
Rating Scale-17 items is equal or more than 2 at randomization or screening.
- Patients with significant medical conditions that are likely to become unstable
during the trial or would likely be destabilized by treatment with atomoxetine or
require treatment with excluded medications.
- Patients with a history of allergy to atomoxetine, severe allergies to more than 1
class of medications, or multiple adverse drug reactions.
- Patients who have received treatment within the past 30 days with a drug that has not
received regulatory approval for any indication at the time the informed consent
document is obtained.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Attention Deficit Hyperactivity Disorder
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Intervention(s)
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Drug: Atomoxetine
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Primary Outcome(s)
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Number of participants with adverse events leading to discontinuation
[Time Frame: Over 48 weeks]
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Secondary Outcome(s)
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Mean change from baseline to 48 weeks endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)
[Time Frame: Baseline and 48 weeks]
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Mean change from baseline to 48 weeks endpoint in comorbid, anxiety symptoms, as measured by Hamilton Anxiety Rating Scale-14 items (HAMA-14)
[Time Frame: Baseline and 48 weeks]
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Mean change from baseline to 48 weeks endpoint in comorbid, depressive symptoms, as measured by Hamilton Depression Rating Scale-17 items (HAMD-17)
[Time Frame: Baseline and 48 weeks]
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Mean change from baseline to 48 weeks endpoint in the by Conners' Adult ADHD Rating Scale- Investigator Rated: Screening Version 18-item total ADHD symptom score (CAARS-InvSV)
[Time Frame: Baseline and 48 weeks]
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Mean change from baseline to 48 weeks endpoint in the Behavior Rating Inventory of Executive Function -Adult (BRIEF-A) Version: Self Report (BRIEF-A:Self Report )
[Time Frame: Baseline and 48 weeks]
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Mean change from baseline to 48 weeks endpoint in the BRIEF-A Version: Informant scores (BRIEF-A:Informant scores)
[Time Frame: Baseline and 48 weeks]
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Mean change from baseline to 48 weeks endpoint in the by the Adult ADHD Quality of Life Measure (AAQoL)
[Time Frame: Baseline and 48 weeks]
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Secondary ID(s)
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12397
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B4Z-JE-LYEK
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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