Venlafaxine Augmentation in Treatment Resistant Depression

Phase 4

Completed

• Conditions: Depression
• Interventions: Drug: Venlafaxine; Drug: Quetiapine

• Registration Number: NCT00253266
• Lead Sponsor: Max-Planck-Institute of Psychiatry

Brief Summary

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

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 Timeline

• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2005-11-11
• Study First Posted: 2005-11-15
• Study Start: 2008-04
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum	Venlafaxine	Quetiapine augmentation
Verum	Quetiapine	Quetiapine augmentation
Placebo	Venlafaxine	"Placebo" augmentation

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HDRS)	after monotherapy and after augmentation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Max Planck Institute of Psychiatry; 🇩🇪 Munich, Bavaria, Germany