Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy (COATS)
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|ClinicalTrials.gov Identifier: NCT00150839|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 14, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major||Drug: Mirtazapine Drug: Venlafaxine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy - a Monocentric, Double-blind, Placebo-controlled Trial|
|Actual Study Start Date :||March 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
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)
- 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 ]
- Tolerability of treatment as assessed using the DOTES scale [ Time Frame: Whole duration of study ]
- Cognitive deficits as judged by the SKT system [ Time Frame: Study duration ]
- Self assessment of depression and anxiety using Beck's Depression/Anxiety Inventory (BDI/BAI) [ Time Frame: Whole study ]
- Changes is blood levels of homocysteine, folate, vit B12, P11 [ Time Frame: whole study duration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150839
|Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg|
|Erlangen, Bavaria, Germany, 91054|
|Principal Investigator:||Stefan Bleich, MD||University Erlangen-Nuremberg|