Major Depression
Conditions
Interventions
Trade Name: Zyprexa
Product Name: Zyprexa
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Olanzapine
CAS Number: 132539-06-1
Current Sponsor code: Olanzapin
Concentration unit: mg milligram(s)
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -informed consent of patient -age 18 - 80 yrs. -diagnosis of major depression according to DSM-IV, unipolar course -Hamilton-Depression-Scale (17 item score) >18 prior to inclusion -response towards therapy with antidepressant and Olanzapine as defined by >50% reduction of HAM-D (17) score -negative pregnancy testing -highly effective contraceptive method in women (Pearl-index=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -duration of current depressive episode > 1yr. -number of previous episodes > 5 -pregnancy, lactation -depressive episode secondary to somatic disease or substance dependency -contraindication for Zyprexa substance or constituents -severe psychotic symptoms and/or hallucinations (PANSS positive scale: 4 or more on one of the following items: delusions P1, hallucinations P3, Delusions of persecution P6) -treatment with interacting substances (CYP1A2 inhibitors or inductors) -treatment with substances prolonging QTc period as listed in the protocol appendix -comorbidity according to DSM-IV, axis I -denial of consent to §12, §13 GCP-V (Germany) -hospital treatment by legal order -hepatic insufficiency, elevation of SGOT, SGPT, and/or GGT of more than 3fold upper reference value -severe neurological or medical disease -adipositas permagna (BMI>30) -HIV-infection -active viral hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Hypothesis: In major depression, long-term add-on treatment with Olanzapine prevents relapse more effectively than treatment with antidepressants alone. Primary endpoint is the relapse rate after response and remission as rated with the Hamilton-Depression Scale (HAM-D-17);Secondary Objective: Secondary endpoints are tolerability and safety of Olanzapine in long-term treatment, long-term efficacy of Olanzapine in major depression with additional mild psychotic features, determination of necessary co-medication, rehospitalisation rate, quality of life, as measured with self-rating scales (SWN: Subjective Wellbeing Under Neuroleptics) and CGI (Clinical Global Impression);Primary end point(s): -relapse rate after response or remission | — |
Countries
Germany
Outcome results
None listed