Conditions

Anxiety Neuroses Anxiety States, Neurotic Neuroses, Anxiety

Outcome Measures

Primary Outcomes (1)

Change From Baseline to 10-Week Endpoint in the Pediatric Anxiety Rating Scale (PARS) Severity Score Evaluated for Symptoms Identified on the Generalized Anxiety Subsection of the PARS Symptom Checklist
PARS severity score for GAD was assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist. PARS severity score for GAD was derived by summing 5 of 7 severity/impairment/interference items (2, 3, 5, 6, 7); each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach adjusted for baseline, pooled investigator, age category, visit, treatment, treatment\*visit, age category\*visit, and baseline\*visit.
Baseline, 10 weeks

Secondary Outcomes (13)

Response Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Pediatric Anxiety Rating Scale (PARS) Severity Score for GAD
Baseline, 10 weeks
Change From Baseline to 10-Week Endpoint on the Pediatric Anxiety Rating Scale (PARS) Severity Total Score Evaluated for All Symptoms Identified on the PARS Symptom Checklist Symptoms
Baseline, 10 weeks
Change From Baseline to 10-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale
Baseline, 10 weeks
Remission Rate at Endpoint for Generalized Anxiety Disorder (GAD) Using Clinical Global Impressions of Severity (CGI-S) Scale
10 weeks
Change From Baseline to 10-Week Endpoint in the Children's Global Assessment Scale (CGAS)
Baseline, 10 weeks
+8 more secondary outcomes

Study Arms (2)

Duloxetine

EXPERIMENTAL

30-120 mg flexible dosing once daily for 10 weeks. At the end of the 10 week blinded treatment period, participants may participate in an 18 week extension

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

Administered once daily for 10 weeks. At the end of the 10 week blinded treatment period, placebo participants receive duloxetine in the 18 week extension

Drug: DuloxetineDrug: Placebo

Interventions

DuloxetineDRUG

Administered orally

Also known as: Cymbalta, LY248686

DuloxetinePlacebo

PlaceboDRUG

Administered orally

Placebo

Eligibility Criteria

Age7 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Diagnosed with GAD on clinical exam as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and supported by the Mini International Neuropsychiatric Interview for children and adolescents (MINI-Kid)
Diagnosis of moderate or greater severity of GAD as determined by the following:
Presence of 4 or more symptoms identified on the generalized anxiety subsection of the Pediatric Anxiety Rating Scale (PARS) symptom checklist at screening and randomization. Two of which are excessive worry and dread or fearful anticipation (nonspecific)
PARS severity score of 15 or more at screening and randomization for symptoms identified on the generalized anxiety subsection of PARS symptom checklist at screening and randomization
Clinical Global Impressions of Severity (CGI-S) rating of 4 or more at screening and randomization
Presence of significant social, academic, and/or familial dysfunction as determined by the Children's Global Assessment Scale (CGAS) score of 60 or less at screening and randomization
Female participants must test negative for pregnancy during screening Furthermore, female participants must agree to abstain from sexual activity or to use a reliable method of birth control as determined by the investigator during the study
Participant's parent/legal representative and participant, if capable, are judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol
Participant's parent/legal representative and participant, if capable, must have a degree of understanding such that they can communicate intelligently with the investigator and study coordinator
Participants must be capable of swallowing study drug whole (without opening the capsule, crushing, dissolving, dividing, et cetera)
Participants must have venous access sufficient to allow blood sampling and are compliant with blood draws as per the protocol

You may not qualify if:

Current diagnosis of major depressive disorder (MDD)
Participants for whom the primary focus of treatment is separation anxiety or social phobia (participants with secondary separation anxiety or social phobia are allowed to participate)
Have current primary diagnosis of any DSM-IV-TR Axis I disorder except GAD, or a current secondary DSM-IV-TR Axis 1 disorder that requires any pharmacologic treatment (other than those disorders listed below). Primary is defined as the disorder that is the primary focus of treatment
Have a history of DSM-IV-TR-defined substance abuse or dependence within the past year, excluding caffeine and nicotine
Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, or pervasive development disorder, as judged by the investigator
Have 1 or more first-degree relatives (parents or siblings) with diagnosed bipolar I disorder
Have a serious or unstable medical illness, psychological condition, clinically significant laboratory or electrocardiogram (ECG) result, hypersensitivity to duloxetine, or its active ingredients, frequent or severe allergic reactions to multiple medications, uncontrolled narrow-angle glaucoma, acute liver injury (for example, hepatitis) or severe cirrhosis (Child-Pugh Class C), or a history of any seizure disorder (other than febrile seizures)
Have a significant suicide attempt within 1 year of screening or are currently at risk of suicide in the opinion of the investigator
Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks prior to screening. Participants who require a change to psychotherapy between weeks 1 through 10 will be excluded
Have a weight less than 20 kilograms at any time during the screening period
Female participants who are pregnant, nursing or have recently given birth

Contact the study team to confirm eligibility.