Youths were included in the study only if they met all of the following criteria: |
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   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. |