The screening assessment consists of a consecutive recruitment of depressed pat. adequately treated for their current depressive episode. 2. Pat. who failed to respond to a well-conducted treatment with an antidepressant and for whom the investigator considers switching to venlafaxine, will start this treatment period.3. Pat. considered as non responders at the end of the the “Venlafaxine treatment”, will be included in a 6 week prospective treatment with Escit..
Conditions
Interventions
Trade Name: Cipralex
Product Name: Escitalopram
Product Code: Lu 26-054
Pharmaceutical Form: Capsule*
Trade Name: Efectin
Product Name: Venlafaxin
Pharmaceutical Form: Capsule, hard
Sponsors
Group for the Study of Resistant Depression (GSRD), Head: Prof. Julien Mendlewicz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In- or outpatient, male or female, between 18 and 65 years of ageThe patient has a Current Major Depressive Episode, assessed with the MINI, moderate or severe, according to DSM-IV-TR criteria (classification code = 296.2x or 296.3x). The patient has been treated for the Current Episode with an antidepressant (other than escitalopram or venlafaxine) prescribed continuously at the optimal dose for at least 4 weeks preceding selection. The patients has a total score of 22 or higher on the MADRS. Escitalopram-Treatment:Any patient who meets the 2 following inclusion criteria at the end of the “Venlafaxine Treatment” is eligible fore inclusion in the “Escitalopram Treatment”1. The patient has a total score of 20 or higher on the MADRS at day 422. The decrease from start of the “Venlafaxine Treatment” in MADRS total score is not higher than 25 %. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Venlafaxine-Treatment:Patient non responder to a combination of 2 antidepressants (at least 2 weeks of treatment with an adequate dose for each of the 2 drugs) and/or to an augmentation therapy (at least 2 weeks with a potentiating agent at any dose) at the time of screeningPatient has one or more of the following conditions: Any Current Psychiatric Disorder established as the principal diagnosis other than Major Depressive Disorder as defined in the DSM-IV-TR (assessed with the MINI), any Substance Disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR, any severe Personality Disorder according to investigator clinical judgement that might compromise the studyPatient has received the following disallowed treatments: antipsychotic drugs, ECT, lithium, carbamazepine, valproate or valpromide, benzodiazepines, anxiolytic, serotinin-agonist (see wash-out according to the study protocol)Patient has been treated during the Current Episode with escitalopram or venlafaxine Escitalopram-Treatment:Any patient who meets the following criteria at the end of the “Venlafaxine Treatment” cannot be included in the “Escitalopram Treatment”:1. The patient has not taken the medication for three consecutive days or more, or overall compliance is less than 80 % during the “Venlafaxine Treatment”
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of escitalopram in treatment resistant depression (TRD), assessed by 2 consecutive failed antidepressive treatments from different classes. The last treatment received is a 6 week prospective trial with venlafaxine. ;Secondary Objective: To assess the safety and tolerability of escitalopram in TRD. To identify predictors factors of clinical response to a serotoninergic antidepressant treatment in patients with TRD and non responders to venlafaxine. To identify possible genetic factors and functional polymorphisms that my predict treatment response and adverse events. ;Primary end point(s): The primary efficacy endpoint will be the mean change in MADRS total score from baseline.The assessment of the treatment resistance to antidepressant therapy will be evidenced in a retrospective and prospective way, 2 consecutive trials will be needed to define TRD as recommended by CPMP guidelines.The data base will also be used to identify predictor factors of clinical response to a serotoninergic antidepressant treatment in patients with TRD and non responders to venlafaxine, including possible genetic factors and functional polymorphisms that my predict treatment response and adverse events. Pharmacogenetics investigatons will identify polymorphic genetic predictive factors in conjunction with clinical factors. | — |
Countries
Austria
Outcome results
None listed