Comparison of venlafaxine augmentation with lamotrigine, quetiapine, or placebo in treatment resistant depression - Venlafaxine augmentatio
- 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
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 220
- 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
- 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
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of Venlafaxine-HCL augmentation with the mood stabilizer Lamotrigine and with the neuroleptic Quetiapine in treatment resistant depression;Secondary Objective: Pharmacogenetic factors contributing to drug efficacy in treatment resistant depression;Primary end point(s): - Psychopathology as asessed by the Hamilton Depression Rating Scale (HDRS) and the Montgomery Asberg Depression Rating Scale (MADRS)<br>- Number of patients with treatment response as indicated by a HDRS reduction of at least 50% compared with baseline after six weeks of augmentation
- Secondary Outcome Measures
Name Time Method