Venlafaxine Augmentation in Treatment Resistant Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Max-Planck-Institute of Psychiatry
Information provided by (Responsible Party):
Max-Planck-Institute of Psychiatry Identifier:
First received: November 11, 2005
Last updated: April 3, 2014
Last verified: April 2014

This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.

Condition Intervention Phase
Drug: Venlafaxine
Drug: Quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression

Resource links provided by NLM:

Further study details as provided by Max-Planck-Institute of Psychiatry:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: after monotherapy and after augmentation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 242
Study Start Date: April 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum
Quetiapine augmentation
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
Placebo Comparator: Placebo
"Placebo" augmentation
Drug: Venlafaxine
Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
Other Name: Trevilor retard

Detailed Description:

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.


Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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
  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 identifier: NCT00253266

Contact: Thomas Nickel, MD 0049 - 89 - 30622 ext 572
Contact: Marcus Ising, PhD 0049 - 89 - 30622 ext 430

Max Planck Institute of Psychiatry Recruiting
Munich, Bavaria, Germany, 80804
Contact: Florian Holsboer, MD, PhD    +49 (0)89 30622 ext 221   
Contact: Nickel Thomas, MD    + 49 (0)8930622 ext 572   
Principal Investigator: Florian Holsboer, MD, PhD         
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
Principal Investigator: Florian Holsboer, MD, PhD Max-Planck-Institute of Psychiatry
  More Information

Additional Information:
No publications provided

Responsible Party: Max-Planck-Institute of Psychiatry Identifier: NCT00253266     History of Changes
Other Study ID Numbers: 01/2005, 2005-001217-17
Study First Received: November 11, 2005
Last Updated: April 3, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Max-Planck-Institute of Psychiatry:
Treatment resistant depression

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents processed this record on March 26, 2015