Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy

NCT00150839 | Completed Phase 4 DMC

• 1 other identifier: COATS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder, Major; Venlafaxine; Mirtazapine; Double-blind RCT; Magnetic resonance imaging; Hippocampal volume

Outcome Measures

Primary Outcomes (1)

• Categorial response to the medication. Categorial response is defined on the basis of CGI Improvement scale and 50% reduction in MADR-S score

  Whole duration of study

Secondary Outcomes (4)

• Tolerability of treatment as assessed using the DOTES scale

  Whole duration of study

• Cognitive deficits as judged by the SKT system

  Study duration

• Self assessment of depression and anxiety using Beck's Depression/Anxiety Inventory (BDI/BAI)

  Whole study

• Changes is blood levels of homocysteine, folate, vit B12, P11

  whole study duration

Study Arms (2)

1

ACTIVE COMPARATOR

Probands receive mirtazapine and venlafaxine

Drug: Venlafaxine

2

PLACEBO COMPARATOR

Patients receive mirtazapine and placebo

Drug: Mirtazapine

Interventions

Mirtazapine DRUG

Patients receive mirtazapine 45mg and placebo.

Also known as: Remergil SolTab (R)

2

Venlafaxine DRUG

Patients receive mirtazapine 45mg and venlafaxine 300mg.

Also known as: Remergil SolTab (R), Trevilor retard (R)

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Mirtazapine; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Stefan Bleich, MD

  University Erlangen-Nuremberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: March 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

DE (1)