Assessment of the efficacy of Venlafaxine-HCL augmentation with the mood stabilizer Lamotrigine and with the neuroleptic Quetiapine in treatment resistant depression

Condition	Intervention	Phase
Treatment Resistant Depression	Drug: Venlafaxine  Drug: Lamotrigine  Drug: Quetiapine	Phase IV

Further study details as provided by Max-Planck-Institute of Psychiatry:

Primary Outcomes: - Hamilton Depression Rating Scale (HDRS); - Montgomery Asberg Depression Rating Scale (MADRS); - Clinical Global Impression (CGI)
Secondary Outcomes: - Self reported psychopathology (BDI, STAI); - Cognitive function; - Activity of endocrine and immunological parameters; - Gene expression profile
Expected Total Enrollment:  120

We examine the efficacy of Venlafaxine-HCL augmentation with the mood stabilizer Lamotrigine and with the neuroleptic Quetiapine in treatment resistant depression in a double-blind randomized clinical trial. Secondary objective is the ecaluation of pharmacogenetic factors contributing to drug efficacy in treatment resistant depression.

Ages Eligible for Study:  20 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

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
• Age between 20 and 70
• Total score > 18 in 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 epsiode

Exclusion Criteria:

• Other psychiatric axis I disorders than those mentioned as Inclusion criteria
• Acute suicidality (Item 3 of the Hamilton Depression Rating Scale > 2)
• Drug or alcohol addiction
• Patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
• Documentation or report of a previous ineffective tratement trial with venlafaxine, lamotrigine or quetiapine
• Functional kidney disorders
• Untreated hypertension
• Acute treatment with thyroid hormone (less than 3 months)
• Preganent or nursing patients
• Women of childbearing age without effective contraception

Please refer to this study by ClinicalTrials.gov identifier  NCT00253266

Thomas Nickel, MD      0049 - 89 - 30622  Ext. 572    nickel@mpipsykl.mpg.de
Hubertus Himmerich, MD      0049 - 89 - 30622  Ext. 638    himmerich@mpipsykl.mpg.de

Germany, Bavaria
      Max-Planck-Institute of Psychiatry, Munich,  Bavaria,  80804,  Germany

Study chairs or principal investigators

Florian Holsboer, MD, PhD,  Principal Investigator,  Max-Planck-Institute of Psychiatry   

Study ID Numbers:  01/2005; EudraCT 2005-001217-17
Last Updated:  December 8, 2005
Record first received:  November 11, 2005
ClinicalTrials.gov Identifier:  NCT00253266
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2006-01-10