Unipolar major depression of moderate to severe severity Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both males and females, age 11 through 17 years 2. Current moderate to severe unipolar major depression (MD) according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
Exclusion criteria
Exclusion criteria: 1. Generalised learning problems (clinical diagnosis) or a pervasive developmental disorder that results in an inability to complete the questionnaires, or both 2. Pregnant, or currently having sexual relations without reliable contraception 3. Currently taking another medication that may interact with a selective serotonin reuptake inhibitor (SSRI) and unable to stop this medication (uncommon)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistence of self-reported depressive symptoms at 52 weeks and recurrence of symptoms by 86 weeks. The instrument is the Mood and Feelings Questionnaire (MFQ) consisting of 33 items (range 0-66, higher scores more symptoms, >27 = clinical level of depression). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) will be completed by the interviewer (blind to treatment arm) (range 0-68, higher score = greater level of personal impairment) 2. The Children's Depression Rating Scale completed by the clinician treating the patient (range 17-113; higher scores = greater severity) 3. Psychiatric diagnosis: Children's Schedule for Affective Disorders (K-Sads); interviewer based diagnostic measure recording presence or absence of unipolar depression and other psychiatric diagnoses at each assessment point. All secondary outcome measures will be assessed at 0, 6, 12, 36, 52 and 86 weeks. | — |
Countries
England, United Kingdom