E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
relapse prevention of alcoholics suffering from persisting craving and/or affective symptoms |
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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 |
Due to Quetiapine’s particulars and the promising receptor profile, we want to examine the efficacy concerning relapse prevention of alcoholics suffering from persisting craving and/or affective symptoms (persisting sleep disorder, persisting excitement, persisting depressive symptoms, persisting anxiety symptoms) in comparison to matching placebo in a double-blind pilot study. |
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E.2.2 | Secondary objectives of the trial |
Evaluation of safety and tolerability of Quetiapine. We further want to compare the course of the above mentioned craving and affective symptoms under medication with quetiapine / matching placebo.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Alcohol dependence according to ICD-10 and DSM-IV since a minimum of 12 months.
2. Detoxified male or female aged between 18 and 65 years.
3. Abstinence for a minimum of 7 days and maximum of 21 days before randomization.
4. Craving : minimum of 5 points at randomisation (OCDS-G)
5. Free informed consent has been given in written form.
6. Women of childbearing potential must use a medically accepted method of contraception. Only methods with a Pearl-index lower than 1% are regarded as acceptable such as hormonal contraception, surgical sterilization, bilateral ovarectomy, and postmenopause (WHO definition: natural menopause retrospectively for at least one year amenorrhoe) without hormonal replacement therapy within the past 5 months.
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E.4 | Principal exclusion criteria |
1. Patients suffering from psychotic diseases and/or depression with psychotic symptoms and/or demented patients, patients with longlasting continous treatment with psychotropic drugs.
2. Known substance abuse other than alcohol or nicotine (except dependence in full remission) as defined by DSM-IV criteria. Patients with a positive urine toxicology screen will be excluded only if they satisfy the DSM-IV criteria for abuse or dependence.
3. Hepatitis (GGT or AST three times above normal range).
4. An absolute neutrophil count (ANC) of 1.5 x 109 per liter.
5. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: unstable DM defined as enrollment glycosylated hemoglobin (HbA1c)>8.5 %; patients admitted to hospital for treatment of DM or DM related illness in past 12 weeks; patients not under physicians care for DM; physicians 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; patient has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 weeks; patients 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.
Evidence of clinical relevant disease or clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by study medication or that would affect study medication.
6. Patients who, in the investigator´s judgement, pose a current serious suicidal risk or have made a suicide attempt within the past 6 months.
7. Restricted or complete legal incapacity.
8. Additional psychotherapy 1 month prior to randomisation or during participation in the study.
9. History of idiopathic orthostatic hypotension, or condition that would predispose to hypotension (e.g. dehydration, hypovolemia).
10. Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, C, via blood or other body fluids (as judged by the investigator). Positive HIV-serology in the screening visit.
11. Known regular treatment with Quetiapine prior to randomisation.
12. Hypersensitivity to Quetiapine or other constituents of the investigational product.
13. Simultaneous intake of Cytochrome-P-450-3A4- inducers or inhibitors: Use of drugs that induce or inhibit the hepatic metabolizing cytochrome 3A4 enzymes within 2 weeks prior to randomization or during the study period, e.g. the inducers: carbamazepine, phenytoin, barbiturates, rifampicin, rifabutin, glucocorticoids, thioridazine and St. Johns wort, and e.g. the inhibitors: HIV-protease-inhibitors, antimycotics of the azole type (e.g. ketoconazole (except for topical use), itroconazole, fluconazole), erythromycin, clarithromycin, fluvoxamine, nefazodone, troleandomycin, indinavir, nelfinavir, ritonavir, and saquinavir.
14. Female patients who are pregnant or are lactating. Women of childbearing potential not using a medically accepted method of contraception with a Pearl-index > 1%.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first severe alcohol relapse in quetiapine treated compared to placebo treated patients. |
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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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |