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Venlafaxine Augmentation in Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT00253266
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.

Condition or disease Intervention/treatment Phase
Depression Drug: Venlafaxine Drug: Quetiapine Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression
Study Start Date : April 2008
Primary Completion Date : April 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (HDRS) [ Time Frame: after monotherapy and after augmentation ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253266


Locations
Germany
Max Planck Institute of Psychiatry
Munich, Bavaria, Germany, 80804
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
Investigators
Principal Investigator: Florian Holsboer, MD, PhD Max-Planck-Institute of Psychiatry
More Information

Responsible Party: Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT00253266     History of Changes
Other Study ID Numbers: 01/2005
2005-001217-17 ( EudraCT Number )
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Quetiapine Fumarate
Venlafaxine Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents