Quetiapine XR in Schizophrenic Patients

NCT01071135 | Terminated Phase 3

• 1 other identifier: D1443C00018
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Quetiapine XR

EXPERIMENTAL

Drug: Quetiapine XR

Interventions

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.

Quetiapine XR

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy or lactation.
• 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%.

Sponsors & Collaborators

• Hannover Medical School: lead
• AstraZeneca: collaborator

Study Sites (3)

Hannover Medical School

Hanover, 30625, Germany

Location

Krankenhaus Lübbecke

Lübbecke, 32312, Germany

Location

Klinikum Wahrendorff

Sehnde, 31319, Germany

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Wolfgang Dillo, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 11, 2011

Record last verified: 2011-08

Locations

DE (3)