Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Venlafaxine
  • Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
• Drug: Quetiapine
  • Quetiapine up to 200 mg/d for four weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Verum
  • Quetiapine augmentation
• Placebo Comparator: Placebo
  • "Placebo" augmentation

Primary Measures

• Hamilton Depression Rating Scale (HDRS)
  • Time Frame: after monotherapy and after augmentation
    Safety Issue?: No

Secondary Measures

• Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])
  • Time Frame: after monotherapy and after augmentation
    Safety Issue?: No
• Cognitive function
  • Time Frame: after monotherapy and after augmentation
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Max-Planck-Institute of Psychiatry

Overall Clinical Trial Officials and Contacts

Florian Holsboer, MD, PhD Principal Investigator Max-Planck-Institute of Psychiatry  

Overall Contact: Thomas Nickel, MD 0049 - 89 - 30622 nickel@mpipsykl.mpg.de

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00253266

Study ID Number: 01/2005

ClinicalTrials.gov Identifier: NCT00253266

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Homepage of the Max Planck Institute of Psychiatry