Patients with Major Depression DSM IV middle serious MedDRA version: 9.1 Level: LLT Classification code 10057840 Term: Major depression
Conditions
Interventions
Trade Name: ReBalance
Product Name: ReBalance
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Johanniskraut-Trockenextrakt
Current Sponsor code: Ze 117
Other descriptive name: Hypericum
C
Sponsors
Max Zeller Söhne AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age at least 18 informed consent Major depression according DSM IV single/repeated episodes middle serious 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: illnesses of thyroid dementia etc dependences danger of suicide contraception by hormones fever heart, liver, kidney, circulation illness etc more
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Avoidance of relapses during therapy with St John Wort (Ze 117);Secondary Objective: Tolerability safety responder variables of efficacy by self-/ physician assessment;Primary end point(s): avoidance of relapses (survival analysis) | — |
Countries
Germany
Outcome results
None listed