Venlafaxine Augmentation in Treatment Resistant Depression - Full Text View

Sponsor:	Max-Planck-Institute of Psychiatry
Information provided by:	Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier:	NCT00253266

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Venlafaxine Venlafaxine hydrochloride Quetiapine Quetiapine fumarate

U.S. FDA Resources

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:	March 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Verum: Experimental Quetiapine augmentation	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
Placebo: Placebo Comparator "Placebo" augmentation	Drug: Venlafaxine Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)

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, Bavaria
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:

Homepage of the Max Planck Institute of Psychiatry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Max-Planck-Institute of Psychiatry ( Prof. Florian Holsboer )
Study ID Numbers:	01/2005, EudraCT 2005-001217-17
Study First Received:	November 11, 2005
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00253266 History of Changes
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:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Depressive Disorder
Serotonin Uptake Inhibitors

Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Serotonin Agents
Mental Disorders
Therapeutic Uses
Venlafaxine
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009