Status:
UNKNOWN
Quetiapine Decreases Smoking in Patients With Chronic Schizophrenia
Lead Sponsor:
Arthur P. Noyes Research Foundation
Conditions:
Smoking Behavior in Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A single-blind switching study in which forty subjects currently being treated with risperidone will be randomly assigned to either stay on risperidone or switched to quetiapine. Various behavioral an...
Detailed Description
STUDY SYNOPSIS Study Design Number of subjects enrolled: Forty patients (Two groups - 20 each) Number of centers: One Study design: Single-blind, Switching Paradigm Extension: None specifically, ...
Eligibility Criteria
Inclusion
- Patients (male or female) between 18-65 years of age must be diagnosed as having DSM-IV schizophrenia (any subtype including schizoaffective disorder).
- Patients must have shown a less-than-optimal clinical response to an adequate course of risperidone treatment and must be willing to agree to the possibility of receiving quetiapine as an alternative treatment for their mild to moderate psychotic symptoms. We define an adequate course of treatment as three or more months of at least 6 mg/day of risperidone. We define less-than-adequate treatment as a Total PANSS Score of 60 or more.
- Patients must be active cigarette smokers. We define active cigarette smoking as patients who consume one pack of cigarettes or more per day. Although there is no standard for defining active cigarette smokers, it has been our experience that the high rate of smoking activity on the hospital wards can have the effect of small elevations in cotinine levels even among "non-smoking" patients through second hand smoke. Therefore, we want to insure that we enroll "heavy" smokers.
- Patients must be able to fully participate in the informed consent and HIPAA process, or have a legal guardian able to participate
Exclusion
- Patients who have had an adequate clinical response to risperidone and are considered by themselves or their treating psychiatrist to be clinically stable.
- Patients who are judged to be treatment refractory, which we define as documented treatment failure with 3 FDA-approved antipsychotic medications administered for an adequate duration in a sufficient dosage (6 or more weeks of 1000 mg/day chlorpromazine equivalents).
- Patients at the time of screening who have clinically significant akathisia (Barnes global score \>2), Parkinsonian symptoms symptoms (Simpson Angus total score \>3), or significant EPS (indicated by treatment with benztropine, lorazepam or propranolol).
- ECG abnormalities consistent with significant or acute cardiac disease.
- History of significant or unstable hypertension during the screening examination outside the range from 90/60 to 140/90, or a pulse outside of the range of 60 to 100 beats per minute.
- Any history of seizures or primary CNS disease (other than tardive dyskinesia or extrapyramidal symptoms from psychotropic medications), comatose states, bone marrow depression, significant cardiovascular, renal or hepatic disease, brain trauma, chronic obstructive lung disease and/or pulmonary emphysema, or a mental deficiency.
- Active drug or alcohol addiction within the past 3-month period.
- Symptoms of significant physical illness in the 4-week period prior to enrollment, excluding mild upper respiratory or gastrointestinal disorders.
- Clinical laboratory findings that indicate the presence of a pathological condition in the judgment of the principal investigator.
- Having received any investigational drug in the 4 weeks preceding the study.
- Pregnant or lactating patients are excluded. Pregnancy must be excluded by laboratory tests prior to beginning the study. Female patients judged to have potential for pregnancy (sexually-active females who do not use an approved form of contraception) will be excluded.
- At serious suicidal risk.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00231101
Start Date
January 1 2004
End Date
June 1 2006
Last Update
October 17 2006
Active Locations (1)
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1
Arthur P. Noyes Research Foundation
Norristown, Pennsylvania, United States, 19401