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Venlafaxine Augmentation in Treatment Resistant Depression

Information source: Max-Planck-Institute of Psychiatry
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression

Intervention: Venlafaxine (Drug); Quetiapine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Max-Planck-Institute of Psychiatry

Official(s) and/or principal investigator(s):
Florian Holsboer, MD, PhD, Principal Investigator, Affiliation: Max-Planck-Institute of Psychiatry

Summary

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

Clinical Details

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

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

Primary outcome: Hamilton Depression Rating Scale (HDRS)

Secondary outcome:

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

Cognitive function

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

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Max Planck Institute of Psychiatry, Munich, Bavaria 80804, Germany
Additional Information

Homepage of the Max Planck Institute of Psychiatry

Starting date: April 2008
Last updated: April 7, 2015

Page last updated: August 23, 2015

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