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Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy

NCT00150839 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-12-14

No results posted yet for this study

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.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Mirtazapine

Patients receive mirtazapine 45mg and placebo.

DRUG

Venlafaxine

Patients receive mirtazapine 45mg and venlafaxine 300mg.

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Stefan Bleich, MD · University Erlangen-Nuremberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00150839 on ClinicalTrials.gov