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Venlafaxine Augmentation in Treatment Resistant Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Venlafaxine
Quetiapine
Sponsored by
Max-Planck-Institute of Psychiatry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Treatment resistant depression, Augmentation, Pharmacogenetics

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Max Planck Institute of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum

Placebo

Arm Description

Quetiapine augmentation

"Placebo" augmentation

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HDRS)

Secondary Outcome Measures

Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])
Cognitive function

Full Information

First Posted
November 11, 2005
Last Updated
April 7, 2015
Sponsor
Max-Planck-Institute of Psychiatry
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1. Study Identification

Unique Protocol Identification Number
NCT00253266
Brief Title
Venlafaxine Augmentation in Treatment Resistant Depression
Official Title
Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Max-Planck-Institute of Psychiatry

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 evaluation of pharmacogenetic factors contributing to drug efficacy in treatment resistant depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Treatment resistant depression, Augmentation, Pharmacogenetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum
Arm Type
Experimental
Arm Description
Quetiapine augmentation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
"Placebo" augmentation
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Other Intervention Name(s)
Trevilor retard
Intervention Description
Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
Quetiapine up to 200 mg/d for four weeks
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS)
Time Frame
after monotherapy and after augmentation
Secondary Outcome Measure Information:
Title
Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])
Time Frame
after monotherapy and after augmentation
Title
Cognitive function
Time Frame
after monotherapy and after augmentation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Holsboer, MD, PhD
Organizational Affiliation
Max-Planck-Institute of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Max Planck Institute of Psychiatry
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80804
Country
Germany

12. IPD Sharing Statement

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Venlafaxine Augmentation in Treatment Resistant Depression

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