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Venlafaxine Augmentation in Treatment Resistant Depression

This study is currently recruiting participants.
Verified February 2012 by Max-Planck-Institute of Psychiatry
Sponsor:
Information provided by (Responsible Party):
Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier:
NCT00253266
First received: November 11, 2005
Last updated: February 8, 2012
Last verified: February 2012
History of Changes

November 11, 2005
February 8, 2012
April 2008
October 2012   (final data collection date for primary outcome measure)
Hamilton Depression Rating Scale (HDRS) [ Time Frame: after monotherapy and after augmentation ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: No ]
  • Cognitive function [ Time Frame: after monotherapy and after augmentation ] [ Designated as safety issue: No ]
  • - Self reported psychopathology (BDI, STAI)
  • - Cognitive function
  • - Activity of endocrine and immunological parameters
  • - Gene expression profile
Not Provided
Not Provided
 
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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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
    Interventions:
    • 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.
 
Recruiting
242
March 2013
October 2012   (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
Both
20 Years to 70 Years
No
Contact: Thomas Nickel, MD 0049 - 89 - 30622 ext 572 nickel@mpipsykl.mpg.de
Contact: Marcus Ising, PhD 0049 - 89 - 30622 ext 430 ising@mpipsykl.mpg.de
Germany
 
NCT00253266
01/2005, 2005-001217-17
Yes
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
February 2012

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