Venlafaxine Augmentation in Treatment Resistant Depression

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00253266

Enrollment

126

Registered

2005-11-15

Start date

2008-04-30

Completion date

2014-08-31

Last updated

2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Treatment resistant depression, Augmentation, Pharmacogenetics

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.

Interventions

DRUGVenlafaxine

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

DRUGQuetiapine

Quetiapine up to 200 mg/d for four weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Rating Scale (HDRS)	after monotherapy and after augmentation

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026