Quetiapine Prolong, Escitalopram and Hypothalamic-pituitary-adrenocortical (HPA) Axis Activity in Depressed Patients

Launched by LUDWIG-MAXIMILIANS - UNIVERSITY OF MUNICH · Aug 5, 2009

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Eligibility criteria

• Inclusion criteria:
• For inclusion in the study patients must fulfil all of the following 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)
• Exclusion criteria:
• Any of the following is regarded as a criterion for exclusion from the study:
• • 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. triptans) 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, metoprolol) 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 109 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 throughout the study with the exception of zopiclon (up to 7.5 mg per day) in case of sleep difficulties and lorazepam (up to 2 mg per day) in case of inner tension and anxiety