A Study in Pediatric Participants With Generalized Anxiety Disorder

Lilly

Status and phase: Completed; Phase 3

Conditions: Anxiety Neuroses; Anxiety States, Neurotic; Neuroses, Anxiety

Treatments: Drug: Duloxetine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01226511

F1J-MC-HMGI (Other Identifier)

12929

Details and patient eligibility

About

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).

Enrollment: 281 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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281 participants in 2 patient groups, including a placebo group

Duloxetine

Experimental group

Description:

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

Treatment:

Drug: Duloxetine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Duloxetine

Drug: Placebo