Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
The proposed study is a randomized, placebo-controlled, double-blind trial to evaluate the
safety and efficacy of antidepressant combination for the treatment of depression.
Depressive disorder is one of the most common human diseases with a high burden for every
patient, her/his family, health care system and society as a whole. Actual treatment concepts
of depressive disorders include pharmacologic, biologic (e.g. electroconvulsive therapy,
light therapy) and psychologic therapy. Even though effective therapeutic options are at
hand, therapy needs time. It is often not possible to reach full remission of the disease and
10-25% of patients suffering from depression are regarded as "treatment-resistant". In
treatment resistant depression, the use of a combination of antidepressive drugs is
considered safe and effective. However, at present no data exist concerning the use of drug
combination as primary therapeutic option. The aim of the study is to examine the hypothesis,
that significantly more patients achieve full remission of depressive symptoms when treated
with the combination of two antidepressants and as a secondary hypothesis, that patients
receiving a drug combination will achieve remission faster than patients treated with
monotherapy. To test these hypotheses, a two group parallel design is used comparing the
efficacy and safety of mirtazapine in combination with venlafaxine or placebo.
Phase:
Phase 4
Details
Lead Sponsor:
University of Erlangen-Nürnberg University of Erlangen-Nürnberg Medical School