Clinical trial NCT01071135 (phase 3, status: terminated)
Conditions: schizophrenia
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9
Drugs: quetiapine xr
SMILES: OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12
Reason stopped: 
    planned number of 30 subjects could not be recruited during recruitment phase.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Females and/or males aged 18 to 60 years.

          2. Provision of written informed consent. In case of acute psychosis written informed
             consent has to be obtained from the legal representative of the patient, if applicable
             or from two independent physicians not involved in the study. When the patient
             recovers, the written informed consent has to be signed by the patient itself.

          3. A diagnosis of schizophrenia (ICD10: F20.0, F20.1, F20.2, F20.4, F20.5) with
             associated cannabis abuse and/or psychotic disorders (e.g. schizophrenia) through
             cannabis (ICD 10: F12.5, F12.7).

          4. A score of at least 15 on the positive scale of the PANSS.

          5. Female patients of childbearing potential must be using a reliable method of
             contraception (i.e. contraceptive pill, contraceptive coil, sterilization,
             hysterectomy) and have a negative blood human chorionic gonadotropin (HCG) test at
             enrollment.

          6. Able to understand and comply with the requirements of the study. In case of acute
             psychosis only those patients are included that are expected to understand the
             requirements under healthy conditions.

        Exclusion Criteria:

          1. Pregnancy or lactation.

          2. Any ICD10 F-criteria 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 themselves 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 3A4 inducers in the 14 days preceding
             enrollment including but not limited to: phenytoin, carbamazepine, barbiturates,
             rifampin, St. John's Wort, and glucocorticoids.

          7. Patients who require treatment with one or more additional neuroleptics to quetiapine.

          8. Administration of a depot antipsychotic injection within one dosing interval (for the
             depot) before randomisation.

          9. Substance or alcohol dependence within 4 weeks prior to enrolment, at enrollment and
             during the study (except for cannabis, caffeine or nicotine dependence), as defined by
             DSM-IV criteria.

         10. Medical conditions that would affect absorption, distribution, metabolism, or
             excretion of study treatment.

         11. Unstable or inadequately treated medical illness (e.g. congestive heart failure,
             angina pectoris, hypertension) as judged by the investigator.

         12. An absolute neutrophil count (ANC) of ≤ 1.5 x 109 per liter.

         13. Involvement in the planning and conduct of the study.

         14. Previous enrollment or randomisation of treatment in the present study.

         15. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

               -  Unstable DM as defined as enrollment glycosylated haemoglobin (HbA1c) >8.5%.

               -  Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.

               -  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.

               -  Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4
                  weeks prior to inclusion. For thiazolidinediones (glitazones) this period should
                  be at least 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.

         16. Previous treatment with study medication within the last 4 weeks prior to enrollment
             into this study.

         17. Participation in another drug trial within 4 weeks prior enrollment into this study or
             current participation in another clinical trial.