Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy (COATS)
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy - a Monocentric, Double-Blind, Placebo-Controlled Trial|
- Categorial response to the medication. Categorial response is defined on the basis of CGI Improvement scale and 50% reduction in MADR-S score [ Time Frame: Whole duration of study ] [ Designated as safety issue: No ]
- Tolerability of treatment as assessed using the DOTES scale [ Time Frame: Whole duration of study ] [ Designated as safety issue: Yes ]
- Cognitive deficits as judged by the SKT system [ Time Frame: Study duration ] [ Designated as safety issue: No ]
- Self assessment of depression and anxiety using Beck's Depression/Anxiety Inventory (BDI/BAI) [ Time Frame: Whole study ] [ Designated as safety issue: No ]
- Changes is blood levels of homocysteine, folate, vit B12, P11 [ Time Frame: whole study duration ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Probands receive mirtazapine and venlafaxine
Patients receive mirtazapine 45mg and venlafaxine 300mg.
Placebo Comparator: 2
Patients receive mirtazapine and placebo
Patients receive mirtazapine 45mg and placebo.
Other Name: Remergil SolTab (R)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00150839
|Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg|
|Erlangen, Bavaria, Germany, 91054|
|Principal Investigator:||Stefan Bleich, MD||University Erlangen-Nuremberg|