Venlafaxine Augmentation in Treatment Resistant Depression
Information source: Max-Planck-Institute of Psychiatry
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Venlafaxine (Drug); Quetiapine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Max-Planck-Institute of Psychiatry Official(s) and/or principal investigator(s):
Florian Holsboer, MD, PhD, Principal Investigator, Affiliation: Max-Planck-Institute of Psychiatry
Overall contact:
Thomas Nickel, MD, Phone: 0049 - 89 - 30622, Ext: 572, Email: nickel@mpipsykl.mpg.de
Summary
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic
quetiapine in treatment resistant depression.
Clinical Details
Official title: Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Hamilton Depression Rating Scale (HDRS)
Secondary outcome: Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])Cognitive function
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 70 Years.
Gender(s): 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
- 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
Locations and Contacts
Thomas Nickel, MD, Phone: 0049 - 89 - 30622, Ext: 572, Email: nickel@mpipsykl.mpg.de
Max-Planck-Institute of Psychiatry, Munich, Bavaria 80804, Germany; Recruiting
Additional Information
Homepage of the Max-Planck-Institute of Psychiatry
Starting date: April 2008
Ending date: March 2011
Last updated: April 11, 2008
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