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Quetiapine XR in Schizophrenic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01071135
Recruitment Status : Terminated (Planned number of 30 subjects could not be recruited during recruitment phase.)
First Posted : February 19, 2010
Last Update Posted : November 11, 2011
Information provided by (Responsible Party):
Wolfgang Dillo, Hannover Medical School

Brief Summary:
The purpose of the study is to determine the effect of Quetiapine in patients with schizophrenia induced by cannabis abuse.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Quetiapine XR Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Quetiapine XR in Schizophrenic Patients With Cannabis Abuse and/or Cannabis Induced Psychosis -Pilot Study-
Study Start Date : September 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Quetiapine

Arm Intervention/treatment
Experimental: Quetiapine XR Drug: Quetiapine XR
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.

Primary Outcome Measures :
  1. Reduction in PANSS total score [ Time Frame: within 3 months ]
    The primary variable will be the proportion of patients with a 30% reduction from screening visit to month 3 in PANSS total score.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01071135

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Hannover Medical School
Hannover, Germany, 30625
Krankenhaus Lübbecke
Lübbecke, Germany, 32312
Klinikum Wahrendorff
Sehnde, Germany, 31319
Sponsors and Collaborators
Hannover Medical School
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Principal Investigator: Wolfgang Dillo, MD Hannover Medical School
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Responsible Party: Wolfgang Dillo, MD, Hannover Medical School Identifier: NCT01071135    
Other Study ID Numbers: D1443C00018
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs