In this study, patients suffering from unipolar depression are investigated. 40 unipolar depressed inpatients (age 18-65) enter the study after the procedure has been fully explained and written informed consent has been obtained. The patients are diagnosed by experienced and trained psychiatrists according to DSM-IV criteria (296.2, 296.3) using the Structured Clinical Interview for DSM-IV, German version (Wittchen et al. 1997). MedDRA version: 9.1 Level: LLT Classification code 10012378 Term:
Conditions
Interventions
Trade Name: Seroquel Prolong 300 mg
Pharmaceutical Form: Tablet
Trade Name: Cipralex 10 mg
Pharmaceutical Form: Tablet
Sponsors
Ludwig-Maximilian-University of Munich, Department of Psychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Inpatients (the admission to hospital occurs independently from study participation) 2. Provision of written informed consent 3. A diagnosis of major depression by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) (unipolar depression: 296.2, 296.3) 4. Female and male patients aged 18 to 65 years 5. Female patients of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at enrolment and e willing to use a reliable method of birth control (i.e. barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal litigation) during the study. 6. Able to understand and comply with the requirements of the study as judged by the investigator. 7. A sum score of at least 18 on the 21-item version of the Hamilton Depression Rating Scale (21-HAMD) 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: 1. Pregnancy or lactation 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria 3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 4. Known intolerance or lack of response to quetiapine fumarate and/or escitalopram, as judged by the investigator 5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir 6. Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids 7. Use of monoamine oxidase inhibitors (MAOIs) or other serotonergic drugs (e.g. triptanes) in the 14 days preceding enrolment 8. Use of oral anticoagulants in the 14 days preceding enrolment 9. History of bleeding disorders. 10. Use of drugs which are mainly metabolized by cytochrome P450 2D6 having a low therapeutic index (e.g. flecainide, propafenone, metoprolole) in the 14 days preceding enrolment 11. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation 12. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria 13. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment 14. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 15. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator 16. Involvement in the planning and conduct of the study 17. Previous enrolment or randomisation of treatment in the present study. 18. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements 19. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: • Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%. • Admitted to hospital for treatment of DM or DM related illness in past 12 weeks. • Not under physician care for DM • Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled. • Physician responsible for patient’s DM care has not approved patient’s participation in the study • Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks. • Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study. 20. An absolute neutrophil count (ANC) of <= 1.5 x 10exp9 per liter 21. Abnormal laboratory parameters of clinical relevance before enrolment 22. Abnormal blood pressure, abnormal electrocardiogram, and/or abnormal electroencephalogram with clinical relevance before enrolment 23. Psychotropic drugs within 3 days before and throug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The atypical antipsychotic quetiapine shows antidepressant efficacy both in bipolar and in unipolar depression. In contrast to reuptake inhibiting antidepressants such as escitalopram which stimulate cortisol secretion after first administration, quetiapine rapidly attenuates hypothalamic-pituitary-adrenocortical (HPA) axis activity in healthy subjects which can be observed already after first administration. Therefore, primary objective is to answer the question whether there are different effects of quetiapine prolong and the SSRI escitalopram on HPA axis activity in depressed patients as measured by serial dexamethasone/CRH tests (week 0, 1, and 5). ;Secondary Objective: We hypothesize that the antidepressant efficacy of quetiapine XR after 5 weeks of treatment and the onset of antidepressant action of quetiapine XR may be related to its presumed inhibitory effects on HPA axis activity in depressed patients. Therefore, secondary objective is to elucidate the questions whether the endocrinological effects of quetiapine XR on HPA system in depressed patients are related to its antidepressant efficacy after 5 weeks of treatment and whether the onset of antidepressant action of quetiapine XR is related to a putative rapid inhibition of HPA axis activity. ;Primary end point(s): Primary endpoint is the following parameter to assess the HPA axis activity: total area under the curve (AUC) value for cortisol during the combined dexamethasone/CRH test calculated according to the trapezoid rule. This parameter has been demonstrated in numerous studies to be adequate in the assessment of HPA system activity and its changes. Secondary endpoints are additional parameters to assess the HPA axis activity (basal plasma concentrations of cortisol and ACTH; salivary cortisol levels) and clinical parameters (21-HAMD, MADRS, CGI) which are well established to assess the severity of depression within clinical trials. | — |
Countries
Germany
Outcome results
None listed