Trial record 1 of 1 for:
NCT00328978
Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects
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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. |
| ClinicalTrials.gov Identifier: NCT00328978 |
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Recruitment Status :
Completed
First Posted : May 24, 2006
Last Update Posted : March 25, 2009
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Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
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Brief Summary:
The purpose of the study is to assess and compare the side effect profile, safety, tolerability and efficacy of schizophrenic or schizoaffective subjects non- or partially- responsive to 800 mg/day of quetiapine treated with either 800 mg/day or more than 800 mg/day of quetiapine during 8 weeks.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia Schizoaffective Disorders | Drug: Quetiapine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 330 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Canadian, Multicenter, Double-Blind, Randomized, Parallel-Group Study of the Safety, Tolerability, and Efficacy of Treatment With Higher Doses of Quetiapine Fumarate (Seroquel®) Greater Than 800 mg/Day in Schizophrenic or Schizoaffective Subjects. |
| Study Start Date : | October 2003 |
| Actual Study Completion Date : | September 2005 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Schizophrenia
Primary Outcome Measures :
- To determine the proportion of subjects (%) experiencing emergent or a worsening of EPS following treatment of quetiapine 800mg or higher than 800 mg/day in schizophrenic or schizoaffective subjects.
Secondary Outcome Measures :
- To determine the safety, tolerability and efficacy of treatment with quetiapine in with doses higher than 800 mg/day in schizophrenic or schizoaffective subjects.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Inclusion Criteria: Men and women, age 18-65 years with persistent positive or negative symptoms with a PANSS total score of ≥ 70 and < 110 and a Clinical Global Improvement (CGI)- Severity of Illness score of at least 4 (moderately ill) at screening. Subjects may be treated as in- or out-patients. Subjects must give written informed consent.
Exclusion Criteria:
- Subjects with other psychiatric, medical or behavioural comorbid disorder that may interfere with study conduct or interpretation.
- Female of childbearing potential, unless the subject is using a reliable method of contraception
- Subjects with alcohol or psychoactive-substance dependence not in full remission or with significant alcohol or substance abuse in the past 3 months will be excluded.
- Laboratory test results outside the range of reference considered by the investigator to be clinically significant.
- Inability to respect the visit schedule and known intolerance to quetiapine at 800mg/day.
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 ClinicalTrials.gov identifier (NCT number): NCT00328978
Locations
| Canada, Alberta | |
| Research Site | |
| Calgary, Alberta, Canada | |
| Research Site | |
| Edmonton, Alberta, Canada | |
| Research Site | |
| West Claresholm, Alberta, Canada | |
| Canada, British Columbia | |
| Research Site | |
| Victoria, British Columbia, Canada | |
| Research Site | |
| White Rock, British Columbia, Canada | |
| Canada, Manitoba | |
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| Winnipeg, Manitoba, Canada | |
| Canada, Nova Scotia | |
| Research Site | |
| Sydney, Nova Scotia, Canada | |
| Canada, Ontario | |
| Research Site | |
| Kingston, Ontario, Canada | |
| Research Site | |
| London, Ontario, Canada | |
| Research Site | |
| Markham, Ontario, Canada | |
| Research Site | |
| Mississauga, Ontario, Canada | |
| Research Site | |
| Ottawa, Ontario, Canada | |
| Research Site | |
| Windsor, Ontario, Canada | |
| Canada, Quebec | |
| Research Site | |
| Montreal, Quebec, Canada | |
| Research Site | |
| Quebec City, Quebec, Canada | |
| Research Site | |
| Verdun, Quebec, Canada | |
| Canada, Saskatchewan | |
| Research Site | |
| Saskatoon, Saskatchewan, Canada | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Canada Medical Director, MD | AstraZeneca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00328978 |
| Other Study ID Numbers: |
DC-990-0165 D1441C00023 |
| First Posted: | May 24, 2006 Key Record Dates |
| Last Update Posted: | March 25, 2009 |
| Last Verified: | March 2009 |
Keywords provided by AstraZeneca:
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schizophrenia schizoaffective disorders |
Additional relevant MeSH terms:
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Schizophrenia Psychotic Disorders 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 |