Venlafaxine Augmentation in Treatment Resistant Depression

NCT00253266 | Completed Phase 4 DMC

• 2 other identifiers: 01/20052005-001217-17
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Keywords

Treatment resistant depression; Augmentation; Pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HDRS)

  after monotherapy and after augmentation

Secondary Outcomes (2)

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

  after monotherapy and after augmentation

• Cognitive function

  after monotherapy and after augmentation

Study Arms (2)

Verum

EXPERIMENTAL

Quetiapine augmentation

Drug: Venlafaxine; Drug: Quetiapine

Placebo

PLACEBO COMPARATOR

"Placebo" augmentation

Drug: Venlafaxine

Interventions

Venlafaxine DRUG

Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)

Also known as: Trevilor retard

Placebo; Verum

Quetiapine DRUG

Quetiapine up to 200 mg/d for four weeks

Also known as: Seroquel

Verum

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead

Study Sites (1)

Max Planck Institute of Psychiatry

Munich, Bavaria, 80804, Germany

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Treatment-Resistant

Interventions

Venlafaxine Hydrochloride; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Florian Holsboer, MD, PhD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2005
• First Posted: November 15, 2005
• Study Start: April 1, 2008
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

DE (1)