Overview

Venlafaxine Augmentation in Treatment Resistant Depression

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
All
Summary
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Max-Planck-Institute of Psychiatry
Treatments:
Quetiapine Fumarate
Venlafaxine Hydrochloride
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