Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study
Percentage of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Baseline Through Week 252
Number of Participants With At Least One SAE
Number of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Baseline Through Week 252

Secondary Outcomes (38)

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Baseline Through Week 252
Number of Participants With At Least One TEAE
Baseline Through Week 252
Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs)
Baseline Through Week 252
Number of Participants With At Least One DCAEs
Baseline Through Week 252
Percentage of Participants Who Discontinued Due to Any Reason
Baseline Through Week 252
+33 more secondary outcomes

Study Arms (1)

Edivoxetine

EXPERIMENTAL

All enrolled participants were administered starting dose of 0.1 milligram per kilogram per day (mg/kg/day), or participant specific known stable dose, rollover participants (LNBJ \[No NCT number\]) and (LNBF \[NCT00922636\]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.

Drug: Edivoxetine

Interventions

EdivoxetineDRUG

0.1 mg/kg/day or participant specific known stable dose, rollover participants (LNBJ \[No NCT number\]) and (LNBF \[NCT00922636\]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.

Also known as: LY2216684

Edivoxetine

Eligibility Criteria

Age6 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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.

You may not qualify if:

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.
+2 more criteria

Contact the study team to confirm eligibility.