| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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.
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10012393 |
| E.1.2 | Term | Depression psychotic |
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| 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 |
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.
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| E.2.2 | Secondary objectives of the trial |
Secondary objectives
To evaluate the safety and tolerability of quetiapine in this same patient population.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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
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| E.4 | Principal 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.
20. Any serious and unstable somatic illness that, in the opinion of the investigator, would be negatively affected by the study medication
21. Participation in another drug trial within 4 weeks prior enrollment into this study (or longer in accordance with local requirements)
22. Patients with insufficient knowledge of the German language
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary efficacy measure will be the change from baseline to endpoint (week 6 LOCF) in MADRS total score. |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| 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 | Information not present in EudraCT |
| 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 | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| 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 | No |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| 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 | Yes |
| 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
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| The end of the trial is defined as the last visit in reference to protocol |
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| 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 | |
| E.8.9.1 | In the Member State concerned days | |
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