Depression Clinical Trial
Official title:
Maintenance Therapies in Recurrent Depression-Study I
This study will evaluate the effectiveness of five combinations of drug therapy and psychotherapy in maintaining remission of depression symptoms in people with recurrent major depression.
Depression is a serious illness that can interfere with a person's ability to work, study,
sleep, eat, and enjoy activities that once were pleasurable. It is characterized by several
symptoms, such as the following: persistent sad, anxious, or "empty" mood; feelings of
hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. If left
untreated, depression symptoms can last for years, and may worsen as time goes on. Even with
treatment, however, it is possible for depression to recur. Remission is a main goal in the
treatment of depression and it may be accomplished through various strategies. This study
will evaluate the effectiveness of five combinations of treatments, including medication
therapy and psychotherapy, in maintaining remission of depression symptoms.
All participants in this study will first be treated with imipramine for 7 to 11 months.
Once remission of depression symptoms has been achieved and maintained for 20 weeks,
participants will be randomly assigned to one of the following five maintenance treatments
for 36 months: psychotherapy plus imipramine; psychotherapy plus placebo; psychotherapy
alone; medication clinic treatment plus imipramine; or medication clinic treatment plus
placebo. Assessments will be made at Weeks 12 and 20 and Months 7, 11, and 36, and will
include the time it takes for depression symptoms to recur, as well as scores on depression
and mania severity scales.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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