Table 1.

Inclusion and exclusion criteria

Youths were included in the study only if they met all of the following criteria:
Male and female outpatients.
Youths whose parent/guardian provided signed informed consent.
Youths who provided signed informed assent.
Youths whose parent/guardian agreed to administer study medication daily.
Youths diagnosed with either a current major depressive disorder or depressive disorder and a comorbid substance-related disorder.
Youths suffering from depressive symptoms of at least moderate severity (CDRS-R score ≥ 40).
Youths were excluded from the study for any of the following reasons:
Youths with a clinically-significant general medical or neurological condition.
Youths with clinical evidence to suggest the presence of mental retardation.
Youths for whom treatment with another psychotropic medication would be anticipated while enrolled in the study.
Youths who received treatment with another psychotropic medication within 2 weeks of receiving blinded study medication.
Youths with a history of intolerance, allergy, or non-response to fluoxetine.
Youths who failed 4 weeks of treatment with a non-TCA, non MAOI antidepressant during the current depressive episode.
Youths with a clinically significant abnormal screening laboratory.
Youths who were actively suicidal, or if in the investigator's judgment participation in the study could place the youth at undue risk.
Diagnosis of any of the following DSM-IV defined disorders: bipolar I or II disorder, psychotic disorder (history), obsessive-compulsive disorder (current), panic disorder (current), bulimia (current), or anorexia (current).
Females who were pregnant or breastfeeding.
Females who were sexually active and were not using medically accepted means of contraception.
Youths who, in the investigator's opinion, required pharmacological detoxification.