IMIPRAMINE TREATMENT OF OPIATE-DEPENDENT PATIENTS WITH DEPRESSIVE-DISORDERS - A PLACEBO-CONTROLLED TRIAL

Background: The literature is inconclusive on the role of antidepressa nt medications in treating drug dependence. Studies have either not fo cused on depressed patients or have selected patients with depressive disorders based on cross-sectional symptoms rather than a syndromal di agnosis. A clinical trial of an antidepressant was, therefore, conduct ed on drug-dependent patients with syndromal depression. Methods: Pati ents receiving methadone hydrochloride maintenance treatment were sele cted if they met the criteria for a DSM-III-R depressive disorder that was chronologically primary, had persisted during a past abstinent pe riod or was long-standing, and persisted during at least I month of st able methadone treatment. Subjects were randomized to a 12-week, doubl e-blind, placebo-controlled trial of imipramine hydrochloride. A favor able response was defined as a Clinical Global Impression scale score for depression of 2 (''much improved'') or 1 (''very much improved'') and at least a 75% reduction in self-reported drug or alcohol use or a bstinence. Results: One hundred thirty-seven patients were randomized, and 84 completed a minimum adequate trial of at least 6 weeks. Among the 84 adequately treated patients, 57% (24/42) receiving imipramine w ere rated as responders compared with 7% (3/42) receiving placebo (P < .001). On measures of mood, there was a robust effect of imipramine, I mipramine was superior to placebo on some self-reported measures of su bstance use and craving, and mood improvement was associated with impr ovement in self-reported substance use. However, few patients achieved urine-confirmed abstinence. Conclusions: Imipramine was an effective antidepressant in patients receiving methadone who were selected via s yndromal criteria for depressive illness, Imipramine patients whose mo od improves; however, this effect was less robust.