E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
|
E.2.2 | Secondary objectives of the trial |
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) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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<1) or sexual abstinence during study period -no participation in any other trial according to German Pharmaceuticals Act (AMG)1month prior to and during study participation -normal liver function (SGOT, SGPT)(see exclusion criteria) |
|
E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
-relapse rate after response or remission |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |