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Venlafaxine Augmentation in Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT00253266
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : April 8, 2015
Information provided by (Responsible Party):
Max-Planck-Institute of Psychiatry

November 11, 2005
November 15, 2005
April 8, 2015
April 2008
April 2014   (Final data collection date for primary outcome measure)
Hamilton Depression Rating Scale (HDRS) [ Time Frame: after monotherapy and after augmentation ]
  • - Hamilton Depression Rating Scale (HDRS)
  • - Montgomery Asberg Depression Rating Scale (MADRS)
  • - Clinical Global Impression (CGI)
Complete list of historical versions of study NCT00253266 on ClinicalTrials.gov Archive Site
  • Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI]) [ Time Frame: after monotherapy and after augmentation ]
  • Cognitive function [ Time Frame: after monotherapy and after augmentation ]
  • - Self reported psychopathology (BDI, STAI)
  • - Cognitive function
  • - Activity of endocrine and immunological parameters
  • - Gene expression profile
Not Provided
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Venlafaxine Augmentation in Treatment Resistant Depression
Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.
We examine the efficacy of Venlafaxine-HCL augmentation with the neuroleptic Quetiapine in treatment resistant depression in a double-blind randomized clinical trial. Secondary objective is the evaluation of pharmacogenetic factors contributing to drug efficacy in treatment resistant depression.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Venlafaxine
    Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
    Other Name: Trevilor retard
  • Drug: Quetiapine
    Quetiapine up to 200 mg/d for four weeks
    Other Name: Seroquel
  • Experimental: Verum
    Quetiapine augmentation
    • Drug: Venlafaxine
    • Drug: Quetiapine
  • Placebo Comparator: Placebo
    "Placebo" augmentation
    Intervention: Drug: Venlafaxine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female and male inpatients with a major depressive disorder without psychotic features or with a depressive episode within a bipolar I or II disorder without psychotic features
  • Ages between 20 and 70 years
  • Total score greater than 18 on the Hamilton Depression Rating Scale
  • Documentation of at least one ineffective antidepressant drug trial under adequate dosage for at least 6 weeks in the current episode

Exclusion Criteria:

  • Other psychiatric axis I disorders than those mentioned as Inclusion criteria
  • Acute suicidality (Item 3 of the Hamilton Depression Rating Scale greater than 2)
  • Drug or alcohol addiction
  • Patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
  • Documentation or report of a previous ineffective treatment trial with venlafaxine, lamotrigine or quetiapine
  • Functional kidney disorders
  • Untreated hypertension
  • Acute treatment with thyroid hormone (less than 3 months)
  • Pregnant or nursing patients
  • Women of childbearing age without effective contraception
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2005-001217-17 ( EudraCT Number )
Not Provided
Not Provided
Max-Planck-Institute of Psychiatry
Max-Planck-Institute of Psychiatry
Not Provided
Principal Investigator: Florian Holsboer, MD, PhD Max-Planck-Institute of Psychiatry
Max-Planck-Institute of Psychiatry
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP