Venlafaxine Augmentation in Treatment Resistant Depression

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

Detailed Description
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Drug: Venlafaxine
* Drug: Quetiapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum<br>Quetiapine augmentation | Drug: Venlafaxine<br>* Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)<br>* Other names: Trevilor retard;Drug: Quetiapine<br>* Quetiapine up to 200 mg/d for four weeks<br>* Other names: Seroquel;|
| Placebo Comparator: Placebo<br>Placebo augmentation | Drug: Venlafaxine<br>* Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)<br>* Other names: Trevilor retard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HDRS) |  | after monotherapy and after augmentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment resistant depression, Augmentation, Pharmacogenetics