Depressive Disorder, Major | Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy
Depressive Disorder, Major research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Depressive Disorder, Major
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MirtazapinePatients receive mirtazapine 45mg and placebo.
Drug:VenlafaxinePatients receive mirtazapine 45mg and venlafaxine 300mg.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1Probands receive mirtazapine and venlafaxine
2Patients receive mirtazapine and placebo
Start Date: March 2006
Completed Date: December 2009
Phase: Phase 4
Primary Outcome: Categorial response to the medication. Categorial response is defined on the basis of CGI Improvement scale and 50% reduction in MADR-S score
Secondary Outcome: Tolerability of treatment as assessed using the DOTES scale
Study sponsors, principal investigator, and references
Principal Investigator: Stefan Bleich, MD
Lead Sponsor: University of Erlangen-Nürnberg