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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001217-17-DE

Enrollment

220

Registered

2005-06-24

Start date

2005-09-12

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment resistant depression

Interventions

Trade Name: Trevilor retard (XR) 75 mg Product Name: Venlafaxine-HCL Pharmaceutical Form: Tablet INN or Proposed INN: venlafaxine hydrochloride CAS Number: 99300-78-4 Current Sponsor code: venlafaxine

Eligibility

Sex/Gender

All

Inclusion 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 - 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

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

Design outcomes

Primary

Measure	Time frame
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) - Number of patients with treatment response as indicated by a HDRS reduction of at least 50% compared with baseline after six weeks of augmentation	—

Measure

Time frame

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) - Number of patients with treatment response as indicated by a HDRS reduction of at least 50% compared with baseline after six weeks of augmentation

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026