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

INTERVENTION: 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 hydrochloride Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 84.84‐ Trade Name: Trevilor retard (XR) 150 mg Product Name: Venlafaxine‐HCL Pharmaceutical Form: Tablet INN or Proposed INN: venlafaxine hydrochloride CAS Number: 99300‐78‐4 Current Sponsor code: venlafaxine hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 169.7‐ Trade Name: 25mg, 1x Elmendos 25 mg, 3x P‐Tabletten Lichtenstein, capsuled Product Name: Lamotrigine Pharmaceutical Form: Capsule, hard INN or Proposed INN: lamotrogine CAS Number: 84057‐84‐1 Current Sponsor code: lamotrogine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: 50mg, 2x Elmendos 25 mg, 2x P‐Tabletten Lichtenstein, capsuled Product Name: Lamotrigine Pharmaceutical Form: Capsule, hard INN or Proposed INN: lamotrogine CAS Number: 84057‐84‐1 Current Sponsor code: lamotrogine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: 100mg, 4x Elmendos 25 mg, capsuled Product Name: Lamotrigine Pharmaceutical Form: Capsule, hard INN or Proposed INN: lamotrogine CAS Number: 84057‐84‐1 Current Sponsor code: lamotrogine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: 50mg, 2x Seroquel 25 mg Filmtabletten, 2x P‐Tabletten Lichtenstein, capsuled Product Name: Quetiapine Pharmaceutical Form: Capsule, hard INN or Propose CONDITION: Treatment resistant depression PRIMARY OUTCOME: Main Objective: Efficacy of Venlafaxine‐HCL augmentation with the mood stabilizer Lamotrigine and with the neuroleptic Quetiapine 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 Secondary Objective: Pharmacogenetic factors contributing to drug efficacy in treatment resistant depression 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