| November 11, 2005 |
| September 17, 2009 |
| April 2008 |
| December 2010 (final data collection date for primary outcome measure) |
| Hamilton Depression Rating Scale (HDRS) [ Time Frame: after monotherapy and after augmentation ] [ Designated as safety issue: No ] |
- - Hamilton Depression Rating Scale (HDRS)
- - Montgomery Asberg Depression Rating Scale (MADRS)
- - Clinical Global Impression (CGI)
|
| Complete list of historical versions of study NCT00253266 on ClinicalTrials.gov Archive Site |
- Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI]) [ Time Frame: after monotherapy and after augmentation ] [ Designated as safety issue: No ]
- Cognitive function [ Time Frame: after monotherapy and after augmentation ] [ Designated as safety issue: No ]
|
- - Self reported psychopathology (BDI, STAI)
- - Cognitive function
- - Activity of endocrine and immunological parameters
- - Gene expression profile
|
| |
| Venlafaxine Augmentation in Treatment Resistant Depression |
| Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression |
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression. |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Depression |
- Drug: Venlafaxine
- Drug: Quetiapine
|
- Experimental: Quetiapine augmentation
- Placebo Comparator: "Placebo" augmentation
|
| |
| |
| Recruiting |
| 242 |
| March 2011 |
| December 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 20 Years to 70 Years |
| No |
|
|
| Germany |
| |
| NCT00253266 |
| Prof. Florian Holsboer, Max-Planck-Institute of Psychiatry |
| 01/2005, EudraCT 2005-001217-17 |
| Max-Planck-Institute of Psychiatry |
|
| Principal Investigator: |
Florian Holsboer, MD, PhD |
Max-Planck-Institute of Psychiatry |
|
|
| Max-Planck-Institute of Psychiatry |
| September 2009 |
