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Planned number of 30 subjects could not be recruited during recruitment phase.
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of the study is to determine the effect of Quetiapine in patients with schizophrenia induced by cannabis abuse.
To evaluate the effect of quetiapine on positive and negative symptoms of schizophrenia on schizophrenic patients associated with cannabis abuse and patients with psychotic disorders through cannabis abuse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine XR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine XR | Drug | Quetiapine XR (Seroquel Prolong®) extended-release tablets à 50 mg und 200 mg. Seroquel Prolong® should be administered as the only neuroleptics preferably once daily, preferably in the evening. The recommended initial dose is 200 mg/day. Patients should be titrated within a dose range of 400 - 800 mg/day depending on the response and tolerance of the individual patient. Dose increases can be made at intervals as short as 1 day and in increments of up to 200 mg/day. Seroquel Prolong® tablets should be swallowed whole and not split, chewed or crushed. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in PANSS total score | The primary variable will be the proportion of patients with a 30% reduction from screening visit to month 3 in PANSS total score. | within 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy or lactation.
Any ICD10 F-criteria not defined in the inclusion criteria.
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to themselves or others.
Known intolerance or lack of response to quetiapine fumarate as judged by the investigator.
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.
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.
Patients who require treatment with one or more additional neuroleptics to quetiapine.
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation.
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.
Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment.
Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator.
An absolute neutrophil count (ANC) of ≤ 1.5 x 109 per liter.
Involvement in the planning and conduct of the study.
Previous enrollment or randomisation of treatment in the present study.
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
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.
Previous treatment with study medication within the last 4 weeks prior to enrollment into this study.
Participation in another drug trial within 4 weeks prior enrollment into this study or current participation in another clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Dillo, MD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Hanover | 30625 | Germany | |||
| Krankenhaus Lübbecke |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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|
| Lübbecke |
| 32312 |
| Germany |
| Klinikum Wahrendorff | Sehnde | 31319 | Germany |