Venlafaxine Augmentation in Treatment Resistant Depression

April 7, 2015 updated by: Max-Planck-Institute of Psychiatry

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80804
        • Max Planck Institute of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Verum
Quetiapine augmentation
Drug: Venlafaxine
Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
Other Names:
  • Trevilor retard
Drug: Quetiapine
Quetiapine up to 200 mg/d for four weeks
Other Names:
  • Seroquel
Placebo Comparator: Placebo
"Placebo" augmentation
Drug: Venlafaxine
Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
Other Names:
  • Trevilor retard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating Scale (HDRS)
Time Frame: after monotherapy and after augmentation
after monotherapy and after augmentation

Secondary Outcome Measures

Outcome Measure
Time Frame
Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])
Time Frame: after monotherapy and after augmentation
after monotherapy and after augmentation
Cognitive function
Time Frame: after monotherapy and after augmentation
after monotherapy and after augmentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Max-Planck-Institute of Psychiatry

Investigators

  • Principal Investigator: Florian Holsboer, MD, PHD, Max-Planck-Institute of Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

November 11, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/2005
  • 2005-001217-17 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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