The planned open and monocentric trial investigates quetiapine as a monotherapy for patients with unipolar depression and psychotic features. The aim of this pilot study is to investigate the antidepressive effect and safety aspects of quetiapine on monopolar depression with psychotic features. MedDRA version: 9.1 Level: LLT Classification code 10012393 Term: Depression psychotic
Conditions
Interventions
Trade Name: Quetiapine
Trade name: Seroquel Prolong
Product Name: Quetiapine/Seroquel Prolong
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapin
Concentration unit: mg milligram(s)
Sponsors
LWL Universitätsklinik für Psychiatrie Bochum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. A diagnosis of depression with psychotic features by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV 296.23;296.33/ICD-10 F31.5, F32.3, F33.3) 3. Females and males aged 18 to 65 years 4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human choriogonadotropine (HCG) test at enrollment. 5. Able to understand and comply with the requirements of the study 6. MADRS score above 20 points 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 or not in full remission (e.g. schizophrenia, bipolar disorder, intoxication) 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, as judged by the investigator 5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment 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 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids 7. Thyroid-stimulating hormone (TSH) concentration more than 10 % above the upper limit of the normal range and the laboratory used for sample analysis at enrollment, whether or not the patient is being treated for hyperthyroidism 8. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation 9. Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria. A urine screen will be performed and the investigator will evaluate the results along with the medical history to find out if the patient meets the DSM-IV criteria for substance dependence. 10. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment 11. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 12. Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B via blood or other body fluids 13. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator 14. 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. 15. An absolute neutrophil count (ANC) ? 1.5 x 109 per liter 16. History of idiopathic orthostatic hypotension, or condition that would predispose to (dehydration, hypovolaemia) 17. ECG considered to show clinical significant abnormalities at enrollment as determined by a cardiologist 18. Involvement in the planning and conduct of the study 19. Previous enrollment or randomisation of treatment in the present study. 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 2.1 Primary objective To investigate the efficacy of Quetiapine in reducing depressive symptoms, as measured by Montgomery-Asberg Scale of Depression in a six weeks trial of depressive patients with psychotic features. ;Secondary Objective: Secondary objectives To evaluate the safety and tolerability of quetiapine in this same patient population. ;Primary end point(s): The primary efficacy measure will be the change from baseline to endpoint (week 6 LOCF) in MADRS total score. | — |
Countries
Germany
Outcome results
None listed