Venlafaxine Augmentation in Treatment Resistant Depression

Max-Planck-Institute of Psychiatry

Status and phase: Completed; Phase 4

Conditions: Depression

Treatments: Drug: Quetiapine; Drug: Venlafaxine

Study type: Interventional

Funder types: Other

Identifiers

NCT00253266

01/2005

2005-001217-17 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 2 patient groups, including a placebo group

Verum

Experimental group

Description:

Quetiapine augmentation

Treatment:

Drug: Venlafaxine

Drug: Quetiapine

Placebo

Placebo Comparator group

Description:

"Placebo" augmentation

Treatment:

Drug: Venlafaxine