Major Depression ICD10: F 32.1, F 32.2, F32.3, F33.1, F33.2, F33.3 Klassifikationscode MedDRA : 10012378 MedDRA version: 21.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Jatrosom N (10 and 20mg Tablets will be used in the trial)
Product Name: Jatrosom N
Pharmaceutical Form: Tablet
Trade Name: Quilonum retard
Product Name: Quilonum retard
Pharmaceutical Fo
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Major Depression • Indication for antidepressiv pharmakotherapy • current in- or outpatient status • insufficient response to a Minimum of one adequate Treatment-attempt with an antidepressant (Minimum dursation of 4 weeks, adequate dose according to product Information) • at baseline MADRS > 20 or MADRS > 16 with no Amelioration in the last 4 weeks • written informed consent after verbal and written information • Age: 18 years or higher • negative pregnancy test • Infertility or highly effective method of contraception (PEARL - Index =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Contraindikationen against TCP, Lithium or the antidepressant thet the patient received prior to study entry (see product informations for list of contraindications). A contraindication to tranylcypromine is, for example, insufficiently adjusted or adjustable arterial hypertension. • Pretreatment with Li.-Aug., TCP, elektroconvulsivetherapy (ECT) in current depressive episode • severe somatic illness with corresponding polypharmacy • Pregnancy, breast-feednig • age > 75 years • women with child-bearing potential and men in reproductive age without using of a highly effective contraception method (PEARL-Index < 1%) • laboratory and / or ECG Findings, that exclude treatment with lithium • depressive Syndrom due to a non-psychiatric condition or secondary due to another axis-I-diagnosis • Diagnosis of antisocial personality disorder, a profound personality disorder, schizophrenia, severe anxiety- or panic-disorder • Diagnosis of dementia or an organic brain-disease • Diagnosis of substance dependency and use of the substance in the last six months (coffein and Nicotin allowed) • psychiatric hospitalisation by law (according to AMG §40 (1) 4)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary aim of the study is to investigate the efficacy of a six-week Treatment with Tranylcypromine (TCP) in doses up to 60mg / day in therapy-resistant unipolar Depression. Evaluation of efficacy is made by comparison with a historical control group of patients receiving lithiumaugmentation taken from the metaanalysis of Bauer et al., 2007 describing a response rate of 42%. In our study the validity of these metaanalytic lithium-response-data will be controlled by a Group of participants receiving lithiumaugmentation. The randomisation-ratio of TCP : Li.Aug. is 3 : 1. This is an open label randomized, multicentre prospective clinical trial in a Simon-Phase-II-design. If a planned Interim-Analysis does not reveal superiority of TCP over Li.-Aug. the study will be terminated previously.;Secondary Objective: Investigation of efficacy (other than Response), tolerability, patients`s satisfaction, qulaity of life, fisibility, sexual dysfunction, body-weight, treatment-effort in patients treated with TCP or Li.-Aug.;Primary end point(s): •Responserate Response is defined as 50% Scorereduktion from Baseline or MADRS (Montgomery Asberg Depression Rating Scale) - score =12 ;Timepoint(s) of evaluation of this end point: weekly assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Remission-rate - Remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) < 12, Hamilton Depression Rating Scale (HAMD-17) < 7 • score-changes in MADRS, HAMD-17, Clinical Global Impression (CGI), BDI-II (Beck Depression Inventory Version 2), Inventory of Depressive Symptoms (IDS) • time to Remission and Response • tolerability and safety measured by the self-rating Antidepressant Side Effect Scale (ASEC) und physicians Adverse Event Report, the percentage of drop-outs, peripheral blood pressure, Laboratory and ECG-findings • treatment satisfaction is measured by Treatment Satisfaction Questionaire (TSQ) • Quality of life is measured by the Quality of Life Questionaire (QLESQ) • Sexual Dysfunktion is measured by the Arizona Sexual Functioning Questionaire (ASEX) • Body-weiht is measured by Body weight in KG and Body Maß Index (BMI) • treatment Fisibility is measured by the estimated time spent on Treatment and the estimated subjective effort rated by physicians, nurses and patients (on a six step Likert scale) • for exploratory Analysis the complete medication is assessed;Timepoint(s) of evaluation of this end point: a) weekly, starting at baseline: MADRS, HAMD-17, BDI-II, IDS, CGI, peripheral blood pressure (RR), ASEC, Adverse Event Report, asessment of medication b)baseline and last visit: ECG, laboratory-findings (according to routine care in the study site), QLESQ, BMI, ASEX c) last visit: asessment of Treatment-fisibility d) telephone Interview after 3 and 6 month after baseline: HAMD, MADRS, BMI, ASEX | — |
Countries
Germany
Contacts
Public ContactKlinik für Psychiatrie (CCM)
Charité Universitätsmedizin Berlin
Outcome results
None listed