Comparison of venlafaxine augmentation with lamotrigine, quetiapine, or placebo in treatment resistant depression - Venlafaxine augmentatio

Active, not recruiting

• Conditions: Treatment resistant depression

• Registration Number: EUCTR2005-001217-17-DE
• Lead Sponsor: Max-Planck-Institute of Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-24
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

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
- Age between 20 and 70
- Total score > 18 in 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 epsiode

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Other psychiatric axis I disorders than those mentioned as Inclusion criteria
- Acute suicidality (Item 3 of the Hamilton Depression Rating Scale > 2)
- Drug or alcohol addiction
- Patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
- Documentation or report of a previous ineffective tratement trial with venlafaxine, lamotrigine or quetiapine
- Functional kidney disorders
- Untreated hypertension
- Acute treatment with thyroid hormone (less than 3 months)
- Preganent or nursing patients
- Women of childbearing age without effective contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified