Skip to main content
OpenTrials
Completed

NCT Number: NCT00253266

Venlafaxine Augmentation in Treatment Resistant Depression

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Max Planck Institute of Psychiatry

Munich, Bavaria, 80804, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venlafaxine

Drug

Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)

Other names: Trevilor retard

Quetiapine

Drug

Quetiapine up to 200 mg/d for four weeks

Other names: Seroquel

Primary outcomes

  1. Hamilton Depression Rating Scale (HDRS)

    Time frame: after monotherapy and after augmentation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Max-Planck-Institute of Psychiatry

Other

Registry information

Official study title

Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Nov 15, 2005
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.