Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy (COATS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by University of Erlangen-Nürnberg Medical School.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Erlangen-Nürnberg
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00150839
First received: September 6, 2005
Last updated: November 20, 2008
Last verified: July 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Depressive Disorder, Major |
Drug: Mirtazapine Drug: Venlafaxine |
Phase 4 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Erlangen-Nürnberg Medical School:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 80 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Probands receive mirtazapine and venlafaxine
|
Drug: Venlafaxine
Patients receive mirtazapine 45mg and venlafaxine 300mg.
Other Names:
|
|
Placebo Comparator: 2
Patients receive mirtazapine and placebo
|
Drug: Mirtazapine
Patients receive mirtazapine 45mg and placebo.
Other Name: Remergil SolTab (R)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150839
Contacts
| Contact: Stefan Bleich, MD | 004991318534262 | stefan.bleich@uk-erlangen.de |
| Contact: Helge Frieling, MD | 004991318534262 | helge.frieling@uk-erlangen.de |
Locations
| Germany | |
| Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg | Recruiting |
| Erlangen, Bavaria, Germany, 91054 | |
| Contact: Stefan Bleich, MD 004991318534262 stefan.bleich@uk-erlangen.de | |
| Principal Investigator: Stefan Bleich, MD | |
| Sub-Investigator: Julia Wilhelm, MD | |
| Sub-Investigator: Helge Frieling, MD | |
Sponsors and Collaborators
University of Erlangen-Nürnberg
Investigators
| Principal Investigator: | Stefan Bleich, MD | University Erlangen-Nuremberg |
More Information
Additional Information:
No publications provided
| Responsible Party: | Stefan Bleich, University of Erlangen-Nürnberg |
| ClinicalTrials.gov Identifier: | NCT00150839 History of Changes |
| Other Study ID Numbers: | COATS |
| Study First Received: | September 6, 2005 |
| Last Updated: | November 20, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Erlangen-Nürnberg Medical School:
|
Depressive Disorder, Major Venlafaxine Mirtazapine |
Double-blind RCT Magnetic resonance imaging Hippocampal volume |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Antidepressive Agents Mirtazapine Mianserin Venlafaxine Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antidepressive Agents, Tricyclic |
Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Serotonin Antagonists Serotonin Agents Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013