Major Depressive Disorder
Conditions
Keywords
depression, major depressive disorder, escitalopram, Lexapro, pediatric
Brief summary
This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD).
Interventions
DRUGEscitalopram
Patients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.
Sponsors
Forest Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Male or female outpatients 7 to 11 years of age, inclusive * Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with a minimum duration of 6 weeks * Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about his or her condition, provides informed consent, and agrees to accompany the patient to all study visits. (Preferably the same parent, guardian, or LAR will accompany the patient to all study visits) * Patient's family is sufficiently organized and stable to guarantee adequate safety monitoring
Exclusion criteria
* Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that was the primary focus of treatment * Patients with a diagnosis of conduct disorder will not be allowed to participate in this study * Current diagnosis of mental retardation, dementia, or amnestic or other cognitive disorders based on DSM-IV-TR criteria * History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or other drugs of the same class * Imminent risk of injuring self or others or causing significant damage to property, as judged by the PI * Suicide risk as determined by meeting any of the following criteria: * Any suicide attempt * Significant risk, as judged by the PI, based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Any Treatment Emergent Adverse Events (TEAEs) | From Baseline (Week 0) to Week 26 | The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period, |
Countries
United States
Participant flow
Recruitment details
Patient recruitment occurred at 16 studies sites located in the US from October of 2010 to August of 2012.
Pre-assignment details
All patients completed a 1-week no-drug screening period before beginning treatment with study drug.
Participants by arm
| Arm | Count |
|---|---|
| Escitalopram Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period. | 118 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Did not meet InclusionExclusion criteria | 30 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Other Reason | 4 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 17 |
Baseline characteristics
| Characteristic | Escitalopram |
|---|---|
| Age, Continuous | 9.4 Years STANDARD_DEVIATION 1.2 |
| Age, Customized Age 11 Years | 25 participants |
| Age, Customized Ages 7 Years to 8 Years | 31 participants |
| Age, Customized Ages 9 Years to 10 Years | 62 participants |
| BMI(Body Mass Index), mean | 20.86 kg/m2 STANDARD_DEVIATION 5.83 |
| Height, mean | 141.27 cm STANDARD_DEVIATION 10.22 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black | 26 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 16 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 102 participants |
| Race/Ethnicity, Customized Other | 4 participants |
| Race/Ethnicity, Customized White | 85 participants |
| Region of Enrollment United States | 118 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 65 Participants |
| Weight, mean | 42.71 kg STANDARD_DEVIATION 16.67 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 59 / 118 |
| serious Total, serious adverse events | 2 / 118 |
Outcome results
Primary
Patients With Any Treatment Emergent Adverse Events (TEAEs)
The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,
Time frame: From Baseline (Week 0) to Week 26
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Escitalopram | Patients With Any Treatment Emergent Adverse Events (TEAEs) | 89 participants |