Status:
COMPLETED
Venlafaxine Augmentation in Treatment Resistant Depression
Lead Sponsor:
Max-Planck-Institute of Psychiatry
Conditions:
Depression
Eligibility:
All Genders
20-70 years
Phase:
PHASE4
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 evalua...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00253266
Start Date
April 1 2008
End Date
August 1 2014
Last Update
April 8 2015
Active Locations (1)
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1
Max Planck Institute of Psychiatry
Munich, Bavaria, Germany, 80804