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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg; University of Erlangen-Nürnberg Medical School
• Treatments: Antidepressive Agents; Mianserin; Mirtazapine; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• Women and men aged 18-55 years

• Moderate to severe depressive episode according to ICD10-criteria ICD10:F32.1, F32.2, F33.1, F33.2) and MADRS-sum value >=18 points

Exclusion Criteria:

• Bipolar affective disorder incl. BD-II.

• Psychiatric or neurologic comorbidity.

• Depression with psychotic symptoms.

• Pregnancy or lactation period.

• Significant cardiovascular or gastrointestinal disease.

• Severe dysfunction of liver (defined according to Child-Pugh-Criteria (>=Child A)) or kidney (defined according to KDIGO stage I (albuminuria >=30mg/g).

• Known and proven pharmacoresistance.

• Proven contraindication against MRI (e.g. pacemaker).

• Known incompatibility against one of the substances used.

• Intake of irreversible inhibitors of monoamine oxidase (MAOI, e.g. tranylcypromine) during last 14 days.

• Known phenylketonuria.

• Women with childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner).