Venlafaxine Augmentation in Treatment Resistant Depression

This study is currently recruiting participants.
Verified April 2014 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: April 3, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Depression
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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253266

Contacts
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

Locations
Germany
Max Planck Institute of Psychiatry Recruiting
Munich, Bavaria, Germany, 80804
Contact: Florian Holsboer, MD, PhD    +49 (0)89 30622 ext 221    holsboer@mpipsykl.mpg.de   
Contact: Nickel Thomas, MD    + 49 (0)8930622 ext 572    nickel@mpipsykl.mpg.de   
Principal Investigator: Florian Holsboer, MD, PhD         
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
Investigators
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
ClinicalTrials.gov 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
Augmentation
Pharmacogenetics

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine
Quetiapine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 15, 2014