THE CONTROLLED EVALUATION OF IMIPRAMINE AND AMITRIPTYLINE IN HOSPITALIZED DEPRESSED PSYCHIATRIC PATIENTS. A CONTRIBUTION TO THE METHODOLOGY OF DRUG EVALUATION.

Abstract

1. Thirty acutely depressed patients were treated with imipramine and amitriptyline for periods of three weeks each in a double blind cross-over design. Twenty-four patients completed the six weeks study period. Clinical improvement on a highly significant level occurred for both drugs. No significant differences could be noted between drugs with the exception of a near significant difference existing at the ten day interval, amitriptyline producing more improvement than imipramine. However, this difference disappeared at the twenty day period. Amitriptyline appears to produce improvement somewhat faster than imipramine, but after about three weeks, imipramine has caught up with amitriptyline. Improvement with both drugs occurred within the first three weeks and could be maintained for another three weeks by the other agent, i.e., drugs were interchangeable after the first three week period. 2. The clinical change noted by the physician may not correspond with the subjective change reported by the patient. The patient may feel improved even though this improvement may not be noticeable to the physician. Even if noticeable, the patient may attribute more importance to such an improvement than does the physician. 3. A cross-over design appears to be inadequate in studies in which one may expect major change to occur within the initial study period. Furthermore, randomization of patients, according to a given criteria, does not necessarily provide randomization for other criteria (e.g., psychological test results in this study).