Quetiapine Decreases Smoking in Patients With Chronic Schizophrenia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Arthur P. Noyes Research Foundation.
Recruitment status was Recruiting
Information provided by:
Arthur P. Noyes Research Foundation
First received: September 30, 2005
Last updated: October 16, 2006
Last verified: September 2005
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 and biological measures will be used to compare smoking behavior over time in these two groups.
Smoking Behavior in Schizophrenia
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
||Quetiapine Decreases Smoking in Patients With Chronic Schizophrenia
Primary Outcome Measures:
- The Fagerstrom Test for Nicotine Dependence,weekly measures of expired CO and blood levels of cotinine. The endpoints for assessing nicotine receptor activation will include: the auditory P50, visuospatial working memory, and the CPT.
- Changes in psychopathology will be performed monthly PANSS, CGI, and the SANS.
- EPS will be measured weekly using the NRS, and the Barnes Akathisia Scale.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00231101
|Arthur P. Noyes Research Foundation
|Norristown, Pennsylvania, United States, 19401 |
|Contact: Richard C Josiassen, Ph.D. email@example.com |
|Principal Investigator: Richard C Josiassen, Ph.D. |
Arthur P. Noyes Research Foundation
||Richard C Josiassen, Ph.D.
||Arthur P. Noyes Research Foundation
No publications provided
History of Changes
|Other Study ID Numbers:
||NSH Protocol 03-08
|Study First Received:
||September 30, 2005
||October 16, 2006
||United States: Institutional Review Board
Keywords provided by Arthur P. Noyes Research Foundation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Schizophrenia and Disorders with Psychotic Features
Central Nervous System Agents
Central Nervous System Depressants
Physiological Effects of Drugs