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
Sponsor:
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
  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:
  • Remergil SolTab (R)
  • Trevilor retard (R)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Venlafaxine
Mirtazapine
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antidepressive Agents, Tricyclic
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on September 18, 2014