- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01071135
Quetiapine XR in Schizophrenic Patients
November 10, 2011 updated by: Wolfgang Dillo, Hannover Medical School
Effects of Quetiapine XR in Schizophrenic Patients With Cannabis Abuse and/or Cannabis Induced Psychosis -Pilot Study-
The purpose of the study is to determine the effect of Quetiapine in patients with schizophrenia induced by cannabis abuse.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hannover, Germany, 30625
- Hannover Medical School
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Lübbecke, Germany, 32312
- Krankenhaus Lübbecke
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Sehnde, Germany, 31319
- Klinikum Wahrendorff
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Females and/or males aged 18 to 60 years.
- 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.
- 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).
- A score of at least 15 on the positive scale of the PANSS.
- 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.
- 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:
- 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:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Quetiapine XR
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in PANSS total score
Time Frame: within 3 months
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The primary variable will be the proportion of patients with a 30% reduction from screening visit to month 3 in PANSS total score.
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within 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wolfgang Dillo, MD, Hannover Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
February 18, 2010
First Submitted That Met QC Criteria
February 18, 2010
First Posted (Estimate)
February 19, 2010
Study Record Updates
Last Update Posted (Estimate)
November 11, 2011
Last Update Submitted That Met QC Criteria
November 10, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1443C00018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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