A Study of Pediatric Participants With Attention Deficit/Hyperactivity Disorder
Status: | Terminated |
---|---|
Conditions: | Neurology, Psychiatric |
Therapuetic Areas: | Neurology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 6 - 18 |
Updated: | 4/29/2018 |
Start Date: | September 2009 |
End Date: | July 2015 |
Long-Term, Open-Label, Safety Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder
The primary purpose of the study is to assess long-term safety and tolerability of
Edivoxetine in pediatric participants with attention deficit hyperactive disorder (ADHD).
Edivoxetine in pediatric participants with attention deficit hyperactive disorder (ADHD).
INCLUSION CRITERIA:
-Participants must meet Diagnostic and Statistical Manual of Mental Disorders 4th Ed
(DSM-IV) diagnostic criteria for ADHD (inattentive, hyperactive/impulsive, or combined
subtypes) based on an interview by an experienced clinician and confirmed using the Kiddie
Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present (SADS)
and Lifetime Version (K-SADS-PL) at Visit 1 for new participants and in the parent trial
for rollover participants.
-Participants must have an ADHDRS-IV-Parent: Inv total score of at least 1.5 standard
deviations above the age/gender norm at both screening/randomization. New participants must
have a Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder- Severity
(CGI-ADHD-S) score greater than or equal to 4 at both screening/randomization.
- Participants of child-bearing potential agree to use a reliable method of birth
control during the study and for 1 month following the last dose of study drug. Female
participants of child-bearing potential must test negative for pregnancy at the time
of enrollment based on a urine pregnancy test.
- Participants must have laboratory results, showing no clinically significant
abnormalities.
- Parents/participants must have a degree of understanding sufficient to communicate
suitably with the investigator/ study coordinator.
- Participants must be of normal intelligence.
- Participants/parents must have been judged by the investigator to be reliable to keep
appointments for clinic visits/all tests, including venipunctures and examinations
required by the protocol.
- Participants must be able to swallow tablets.
EXCLUSION CRITERIA:
- Participants who weigh less than 16 kg at screening/randomization.
- Female participants who are pregnant/breastfeeding.
- Participants who have previously withdrawn/discontinued early from this study or any
other study investigating Edivoxetine.
- Participants who have a history of Bipolar I/II disorder, psychosis, or pervasive
developmental disorder.
- Participants with a history of any seizure disorder or known electroencephalographic
(EEG) abnormalities in the absence of seizures.
- Participants who are at serious suicidal risk.
- Participants with a history of severe allergies to more than 1 class of medications,
or multiple adverse drug reactions, or known hypersensitivity to Edivoxetine.
- Participants with a history of alcohol or drug abuse/dependence within the past 3
months of screening, or who are currently using alcohol, drugs of abuse, or any
prescribed or over-the-counter medication in a manner that the investigator considers
indicative of abuse/dependence.
- Participants who screen positive for drugs of abuse cannot participate.
- Participants who have a medical condition that would increase sympathetic nervous
system activity markedly, or who are taking a medication on a daily basis that has
sympathomimetic activity are excluded.
- Participants with problems that would be exacerbated by increased norepinephrine tone
including a history of cardiovascular disease, thyroid dysfunction, glaucoma, or
urinary retention.
- Participants who at any time during the study are likely to need psychotropic
medications apart from the drugs under study.
- Participants who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks
prior to randomization.
- Participants with current or past history of clinically significant hypertension.
- Participants who are currently enrolled in, or discontinued within the last 30 days
from a clinical trial involving an off-label use of an investigational drug, or
concurrently enrolled in any other type of medical research judged not to be
scientifically or medically compatible with this study.
- Participants whose family anticipates a move outside the geographic range of the
investigative site during participation in the study or who plan extended travel
inconsistent with the recommended visit intervals.
- Participants who, in the opinion of the investigator, are unsuitable in any other way
to participate in this study.
We found this trial at
17
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials