A Study in Pediatric Participants With Generalized Anxiety Disorder
Condition: Anxiety Neuroses; Anxiety States, Neurotic; Neuroses, Anxiety
MeSH terms: Anxiety Disorders; Neurotic Disorders
Intervention: Duloxetine; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 281.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out if duloxetine [30-120 milligrams (mg)] given once a
      day by mouth for 10 weeks to children and adolescents, is better than placebo when treating
      Generalized Anxiety Disorder (GAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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