Venlafaxine Augmentation in Treatment Resistant Depression
This study is currently recruiting participants.
Verified February 2012 by Max-Planck-Institute of Psychiatry
Sponsor:
Max-Planck-Institute of Psychiatry
Information provided by (Responsible Party):
Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier:
NCT00253266
First received: November 11, 2005
Last updated: February 8, 2012
Last verified: February 2012
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Purpose
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Venlafaxine Drug: Quetiapine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression |
Resource links provided by NLM:
MedlinePlus related topics:
Depression
Drug Information available for:
Venlafaxine
Venlafaxine hydrochloride
Quetiapine
Quetiapine fumarate
U.S. FDA Resources
Further study details as provided by Max-Planck-Institute of Psychiatry:
Primary Outcome Measures:
- Hamilton Depression Rating Scale (HDRS) [ Time Frame: after monotherapy and after augmentation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 242 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Verum
Quetiapine augmentation
|
Drug: Venlafaxine
Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
Other Name: Trevilor retard
Drug: Quetiapine
Quetiapine up to 200 mg/d for four weeks
Other Name: Seroquel
|
|
Placebo Comparator: Placebo
"Placebo" augmentation
|
Drug: Venlafaxine
Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
Other Name: Trevilor retard
|
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| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253266
Contacts
| Contact: Thomas Nickel, MD | 0049 - 89 - 30622 ext 572 | nickel@mpipsykl.mpg.de |
| Contact: Marcus Ising, PhD | 0049 - 89 - 30622 ext 430 | ising@mpipsykl.mpg.de |
Locations
| Germany | |
| Max Planck Institute of Psychiatry | Recruiting |
| Munich, Bavaria, Germany, 80804 | |
| Contact: Florian Holsboer, MD, PhD +49 (0)89 30622 ext 221 holsboer@mpipsykl.mpg.de | |
| Contact: Nickel Thomas, MD + 49 (0)8930622 ext 572 nickel@mpipsykl.mpg.de | |
| Principal Investigator: Florian Holsboer, MD, PhD | |
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
Investigators
| Principal Investigator: | Florian Holsboer, MD, PhD | Max-Planck-Institute of Psychiatry |
More Information
Additional Information:
No publications provided
| Responsible Party: | Max-Planck-Institute of Psychiatry |
| ClinicalTrials.gov Identifier: | NCT00253266 History of Changes |
| Other Study ID Numbers: | 01/2005, 2005-001217-17 |
| Study First Received: | November 11, 2005 |
| Last Updated: | February 8, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Max-Planck-Institute of Psychiatry:
|
Treatment resistant depression Augmentation Pharmacogenetics |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Venlafaxine Quetiapine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 23, 2013