There is no proven effective treatment for adolescent major depressive disorder (MDD). The reported studies of treatment with tricyclic antidepressant medications have failed to find differences between the medication and placebo. The present study is proposed under the Public Academic Liaison (PAL) Program. The protocol involves a 3 week, single blind, placebo washout, followed by a 10 week, double blind, placebo controlled study of amitriptyline (AMI) in inpatient, non-psychotic, non-bipolar MDD. AMI plasma levels will be measured to study the relationship between medication level and clinical response. This study will help answer the question, which remains an open one, of whether tricyclic antidepressants have a legitimate role in the treatment of depression in adolescent inpatients with major depressive disorder. If this question is answered in the negative, studies of other types of agents will then be embarked upon. Attending were a member of the committee (Dr. Geller), two ad hoc visitors (Drs. Gabrielle Carlson and Barry Garfinkel) knowledgeable in areas relating to the application, and the Executive Secretary of the committee. The findings of the site visit team were considered by the committee at its review meeting, and have been incorporated in this summary statement.
| Birmaher, B (1998) Should we use antidepressant medications for children and adolescents with depressive disorders? Psychopharmacol Bull 34:35-9 |
| Birmaher, B; Waterman, G S; Ryan, N D et al. (1998) Randomized, controlled trial of amitriptyline versus placebo for adolescents with ""treatment-resistant"" major depression. J Am Acad Child Adolesc Psychiatry 37:527-35 |
| Birmaher, B; Ryan, N D; Williamson, D E et al. (1996) Childhood and adolescent depression: a review of the past 10 years. Part I. J Am Acad Child Adolesc Psychiatry 35:1427-39 |
| Birmaher, B; Ryan, N D; Williamson, D E et al. (1996) Childhood and adolescent depression: a review of the past 10 years. Part II. J Am Acad Child Adolesc Psychiatry 35:1575-83 |
