The success with which tricyclics and other antidepressants have been used to treat panic disorders and the possible success of a tricyclic in inducing symptom relief in primarily anxious outpatients have contributed to the development of increased interest in the anxiolytic properties of antidepressants. A tendency to abuse the benzodiazepines, along with their reputation for addictive properties and engendering tolerance, has increased the importance of finding anxiolytics of distinctive chemical composition. A study is proposed to compare the efficacy of: a) a widely used and demonstrably effective benzodiazepine (diazepam); b) an effective tricyclic antidepressant established as a possibly effective anxiolytic (imipramine); c) a non-tricyclic, second generation antidepressant of established efficacy but untried as an anxiolytic (trazodone); and d) an inert placebo in the treatment of Generalized Anxiety Disorder (GAD) in a sample of family practice patients. In addition to meeting the criteria for diagnosis as GAD, patients must have been suffering from anxiety of at least moderate severity for at least 3 months to qualify for study participation. The proposed study involves: a) a one-week placebo washout period preceded by at least one week during which no psychotropic medications are taken; b) an 8-week double-blind treatment period with assessments after 1, 2, 3, 4, 6, and 8 weeks; c) an assessment at Week 9 after a final week of placebo treatment; and d) a 17-week assessment at the end of a 2-month follow-up period of improved patients. Frequent assessments early in the trial are included to enhance the likelihood of detecting differences across treatments in the temporal course of symptom relief. The possible impact upon treatment outcome of concomitant depression, phobic- and panic-like symptoms, obsessive-compulsive tendencies, feelings of inferiority and resentment leading to interpersonal difficulties, and the chronicity of anxiety will be examined.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH040000-03
Application #
3377840
Study Section
(TDAB)
Project Start
1984-09-30
Project End
1988-08-31
Budget Start
1986-09-01
Budget End
1987-08-31
Support Year
3
Fiscal Year
1986
Total Cost
Indirect Cost
Name
University of Pennsylvania
Department
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104