Venlafaxine Augmentation in Treatment Resistant Depression

Depression Clinical Trial

Official title:

Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253266
• Other study ID #: 01/2005
• Secondary ID: 2005-001217-17
• Status: Completed
• Phase: Phase 4
• First received: November 11, 2005
• Last updated: April 7, 2015
• Start date: April 2008
• Est. completion date: August 2014

Study information

• Verified date: April 2015
• Source: Max-Planck-Institute of Psychiatry
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Intervention

Drug:
• Venlafaxine
Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
• Quetiapine
Quetiapine up to 200 mg/d for four weeks

Locations

Country	Name	City	State
Germany	Max Planck Institute of Psychiatry	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Max-Planck-Institute of Psychiatry

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HDRS)		after monotherapy and after augmentation	No
Secondary	Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])		after monotherapy and after augmentation	No
Secondary	Cognitive function		after monotherapy and after augmentation	No